M. Alexander Otto

VANCOUVER – Perhaps in the not-too-distant future, people at risk for type 1 diabetes will be screened for antibodies against beta cells, and, if two or more are present, started on immunotherapy to prevent beta cell destruction and clinical disease.

The vision is to treat “islet autoimmunity” as we do hypertension and other silent diseases to prevent problems down the road.

In the everyday medical world, that’s mostly science fiction for now – treatment starts when symptoms emerge – but researchers around the world are working hard to make it a reality, including Dr. Carla J. Greenbaum, director of the Diabetes Research Program at the Benaroya Research Institute in Seattle.

It’s known now that when babies have two or more antibodies against beta cells, about 11% per year will develop clinical diabetes, and all of them eventually. Adults with two or more antibodies will also develop diabetes, although at a slower rate than children.

“The take-home message is that type 1 diabetes starts when you have two antibodies. We need to change from symptom management to disease-modifying therapy, and that will require immunotherapy; it will be the future of diabetes care. Endocrinologists need to learn about immunotherapy,” Dr. Greenbaum said at the World Diabetes Congress.

So far, studies of four immunotherapies – teplizumab (Diabetes. 2013 Nov;62[11]:3766-74), rituximab (N Engl J Med. 2009 Nov 26;361[22]:2143-52), abatacept (Diabetes Care. 2014 Apr;37[4]:1069-75), and, most recently, alefacept (J Clin Invest. 2015 Aug 3;125[8]:3285-96) – have shown positive outcomes in preserving beta cell function after diagnosis of type 1. “The positive results are largely driven by children,” she said, suggesting that they might benefit most from a screen-and-treat approach to islet autoimmunity.

Teplizumab, oral insulin, and abatacept are now being tested in antibody-positive patients who haven’t developed symptoms. The trials aim to reduce the risk of clinical disease by 40%. If successful, treating 100 people with islet autoimmunity would prevent 14 from getting clinical type 1 diabetes, said Dr. Greenbaum, who is involved in the work.

A lot of questions need to be answered if the results pan out. Who should be screened, for instance, and how, and what immunotherapies should be used in different patient groups? What’s the right balance between risks and benefits?

There’s also a big question about how to “bring disease-modifying therapies to the clinic. As endocrinologists, we don’t use immunotherapies, but it’s important to recognize that millions of people for many decades have been using them safely to change the course of disease. We need to learn how to do this,” Dr. Greenbaum said.

“I often get people saying immunotherapy doesn’t really work, but that’s not true.” The effect sizes are small – maybe 20% – but it’s the same case in multiple sclerosis and rheumatoid arthritis. “The issue is if you have a weak joint, and you are 20% better, you feel it, but if beta cells are doing better, you might not notice,” she said.

Dr. Greenbaum disclosed research support from Novo Nordisk.

[email protected]

VANCOUVER – Perhaps in the not-too-distant future, people at risk for type 1 diabetes will be screened for antibodies against beta cells, and, if two or more are present, started on immunotherapy to prevent beta cell destruction and clinical disease.

The vision is to treat “islet autoimmunity” as we do hypertension and other silent diseases to prevent problems down the road.

In the everyday medical world, that’s mostly science fiction for now – treatment starts when symptoms emerge – but researchers around the world are working hard to make it a reality, including Dr. Carla J. Greenbaum, director of the Diabetes Research Program at the Benaroya Research Institute in Seattle.

It’s known now that when babies have two or more antibodies against beta cells, about 11% per year will develop clinical diabetes, and all of them eventually. Adults with two or more antibodies will also develop diabetes, although at a slower rate than children.

“The take-home message is that type 1 diabetes starts when you have two antibodies. We need to change from symptom management to disease-modifying therapy, and that will require immunotherapy; it will be the future of diabetes care. Endocrinologists need to learn about immunotherapy,” Dr. Greenbaum said at the World Diabetes Congress.

So far, studies of four immunotherapies – teplizumab (Diabetes. 2013 Nov;62[11]:3766-74), rituximab (N Engl J Med. 2009 Nov 26;361[22]:2143-52), abatacept (Diabetes Care. 2014 Apr;37[4]:1069-75), and, most recently, alefacept (J Clin Invest. 2015 Aug 3;125[8]:3285-96) – have shown positive outcomes in preserving beta cell function after diagnosis of type 1. “The positive results are largely driven by children,” she said, suggesting that they might benefit most from a screen-and-treat approach to islet autoimmunity.

Teplizumab, oral insulin, and abatacept are now being tested in antibody-positive patients who haven’t developed symptoms. The trials aim to reduce the risk of clinical disease by 40%. If successful, treating 100 people with islet autoimmunity would prevent 14 from getting clinical type 1 diabetes, said Dr. Greenbaum, who is involved in the work.

A lot of questions need to be answered if the results pan out. Who should be screened, for instance, and how, and what immunotherapies should be used in different patient groups? What’s the right balance between risks and benefits?

There’s also a big question about how to “bring disease-modifying therapies to the clinic. As endocrinologists, we don’t use immunotherapies, but it’s important to recognize that millions of people for many decades have been using them safely to change the course of disease. We need to learn how to do this,” Dr. Greenbaum said.

“I often get people saying immunotherapy doesn’t really work, but that’s not true.” The effect sizes are small – maybe 20% – but it’s the same case in multiple sclerosis and rheumatoid arthritis. “The issue is if you have a weak joint, and you are 20% better, you feel it, but if beta cells are doing better, you might not notice,” she said.

Dr. Greenbaum disclosed research support from Novo Nordisk.

[email protected]

VANCOUVER – Perhaps in the not-too-distant future, people at risk for type 1 diabetes will be screened for antibodies against beta cells, and, if two or more are present, started on immunotherapy to prevent beta cell destruction and clinical disease.

The vision is to treat “islet autoimmunity” as we do hypertension and other silent diseases to prevent problems down the road.

In the everyday medical world, that’s mostly science fiction for now – treatment starts when symptoms emerge – but researchers around the world are working hard to make it a reality, including Dr. Carla J. Greenbaum, director of the Diabetes Research Program at the Benaroya Research Institute in Seattle.

It’s known now that when babies have two or more antibodies against beta cells, about 11% per year will develop clinical diabetes, and all of them eventually. Adults with two or more antibodies will also develop diabetes, although at a slower rate than children.

“The take-home message is that type 1 diabetes starts when you have two antibodies. We need to change from symptom management to disease-modifying therapy, and that will require immunotherapy; it will be the future of diabetes care. Endocrinologists need to learn about immunotherapy,” Dr. Greenbaum said at the World Diabetes Congress.

So far, studies of four immunotherapies – teplizumab (Diabetes. 2013 Nov;62[11]:3766-74), rituximab (N Engl J Med. 2009 Nov 26;361[22]:2143-52), abatacept (Diabetes Care. 2014 Apr;37[4]:1069-75), and, most recently, alefacept (J Clin Invest. 2015 Aug 3;125[8]:3285-96) – have shown positive outcomes in preserving beta cell function after diagnosis of type 1. “The positive results are largely driven by children,” she said, suggesting that they might benefit most from a screen-and-treat approach to islet autoimmunity.

Teplizumab, oral insulin, and abatacept are now being tested in antibody-positive patients who haven’t developed symptoms. The trials aim to reduce the risk of clinical disease by 40%. If successful, treating 100 people with islet autoimmunity would prevent 14 from getting clinical type 1 diabetes, said Dr. Greenbaum, who is involved in the work.

A lot of questions need to be answered if the results pan out. Who should be screened, for instance, and how, and what immunotherapies should be used in different patient groups? What’s the right balance between risks and benefits?

There’s also a big question about how to “bring disease-modifying therapies to the clinic. As endocrinologists, we don’t use immunotherapies, but it’s important to recognize that millions of people for many decades have been using them safely to change the course of disease. We need to learn how to do this,” Dr. Greenbaum said.

“I often get people saying immunotherapy doesn’t really work, but that’s not true.” The effect sizes are small – maybe 20% – but it’s the same case in multiple sclerosis and rheumatoid arthritis. “The issue is if you have a weak joint, and you are 20% better, you feel it, but if beta cells are doing better, you might not notice,” she said.

Dr. Greenbaum disclosed research support from Novo Nordisk.

[email protected]

VANCOUVER – When diabetes is diagnosed from ages 15 to 30 years, type 2 patients are less likely than are type 1 patients to reach their 50th birthday, according to investigators from the University of Sydney.

Even just a few years after diagnosis, young type 2 patients have a worse cardiovascular profile and worse cardiovascular disease, which leads to an earlier death.

“We pay less attention to type 2 than type 1 in young people. They’re not as sick, and don’t develop [diabetic ketoacidosis] if they miss a treatment. But young type 2 is not a milder form of diabetes in young people, and its detrimental impact occurs early. Before we know what’s going on, patients are middle age, and it’s too late,” said investigator Maria Constantino, a Ph.D. candidate, nurse, and diabetes researcher and educator at the University of Sydney.

Screening for type 2 diabetes “should start at a young age in at-risk groups,” and diabetes cardiovascular risk criteria should be reconsidered so that younger type 2 patients aren’t overlooked because of their age. Current criteria likely “lead to delay in preventive treatment” in the young, she said.

The conclusions come from a review of diabetes patients treated since 1990 at the Royal Prince Alfred Hospital in Sydney (Diabetes Care. 2013 Dec; 36[12]:3863-9).

The investigators compared 354 type 2 patients with 470 type 1 patients diagnosed from age 15-30 years. By around the age of 40 years, 11% of the type 2 patients had died, vs. 6.8% with type 1 (hazard ratio, 2.0; 95% confidence interval, 1.2-3.2; P = .003). Strokes, coronary artery disease, and other macrovascular complications were also far more common in the type 2 group, and they had worse hypertension and dyslipidemia despite taking more drugs to combat both. Type 2 patients also had more albuminuria and neuropathy.

The differences occurred despite the fact that type 2 patients smoked less, had a slightly shorter duration of disease (11.6 vs. 14.7 years), and equivalent glycemic control with their type 1 counterparts, with a mean hemoglobin A_1c of 8.1% in both groups. They were heavier, however, with a mean body mass index of 32.2 kg/m² vs. 25.6 kg/m² in type 1 patients.

In short, young-onset type 2 is a “more lethal phenotype of diabetes. We are not saying one type of diabetes is more important; we need to conquer both.” But in young type 2 patients, “we need to focus on more than just glycemic control.” Cardiovascular risk factors are “detectable early, and treatable,” Ms. Constantino said.

The investigators also compared their 354 young-onset type 2 patients with 1,062 patients diagnosed from age 40-50 years.

By the time they were about 50 years old, young-onset patients were 6.5 times more likely to have died than were their age-matched peers without diabetes in the general Australian population. The peak in excess mortality for those diagnosed in their 5th decade came at about age of 65 years, with a risk of death about 2.5 times higher than nondiabetic peers in the general population.

“The impact of type 2 is much higher the younger a person is. You can argue that in our enthusiasm to diagnose diabetes, we are casting our screening net wider and wider, and take pride in diagnosing many elderly patients with diabetes, but we should not lose sight of the fact that finding and treating an elderly person with diabetes has much less impact than finding and treating one in a young age group,” she said.

Ms. Constantino has no conflicts of interest.

[email protected]

VANCOUVER – When diabetes is diagnosed from ages 15 to 30 years, type 2 patients are less likely than are type 1 patients to reach their 50th birthday, according to investigators from the University of Sydney.

Even just a few years after diagnosis, young type 2 patients have a worse cardiovascular profile and worse cardiovascular disease, which leads to an earlier death.

“We pay less attention to type 2 than type 1 in young people. They’re not as sick, and don’t develop [diabetic ketoacidosis] if they miss a treatment. But young type 2 is not a milder form of diabetes in young people, and its detrimental impact occurs early. Before we know what’s going on, patients are middle age, and it’s too late,” said investigator Maria Constantino, a Ph.D. candidate, nurse, and diabetes researcher and educator at the University of Sydney.

Screening for type 2 diabetes “should start at a young age in at-risk groups,” and diabetes cardiovascular risk criteria should be reconsidered so that younger type 2 patients aren’t overlooked because of their age. Current criteria likely “lead to delay in preventive treatment” in the young, she said.

The conclusions come from a review of diabetes patients treated since 1990 at the Royal Prince Alfred Hospital in Sydney (Diabetes Care. 2013 Dec; 36[12]:3863-9).

The investigators compared 354 type 2 patients with 470 type 1 patients diagnosed from age 15-30 years. By around the age of 40 years, 11% of the type 2 patients had died, vs. 6.8% with type 1 (hazard ratio, 2.0; 95% confidence interval, 1.2-3.2; P = .003). Strokes, coronary artery disease, and other macrovascular complications were also far more common in the type 2 group, and they had worse hypertension and dyslipidemia despite taking more drugs to combat both. Type 2 patients also had more albuminuria and neuropathy.

The differences occurred despite the fact that type 2 patients smoked less, had a slightly shorter duration of disease (11.6 vs. 14.7 years), and equivalent glycemic control with their type 1 counterparts, with a mean hemoglobin A_1c of 8.1% in both groups. They were heavier, however, with a mean body mass index of 32.2 kg/m² vs. 25.6 kg/m² in type 1 patients.

In short, young-onset type 2 is a “more lethal phenotype of diabetes. We are not saying one type of diabetes is more important; we need to conquer both.” But in young type 2 patients, “we need to focus on more than just glycemic control.” Cardiovascular risk factors are “detectable early, and treatable,” Ms. Constantino said.

The investigators also compared their 354 young-onset type 2 patients with 1,062 patients diagnosed from age 40-50 years.

By the time they were about 50 years old, young-onset patients were 6.5 times more likely to have died than were their age-matched peers without diabetes in the general Australian population. The peak in excess mortality for those diagnosed in their 5th decade came at about age of 65 years, with a risk of death about 2.5 times higher than nondiabetic peers in the general population.

“The impact of type 2 is much higher the younger a person is. You can argue that in our enthusiasm to diagnose diabetes, we are casting our screening net wider and wider, and take pride in diagnosing many elderly patients with diabetes, but we should not lose sight of the fact that finding and treating an elderly person with diabetes has much less impact than finding and treating one in a young age group,” she said.

Ms. Constantino has no conflicts of interest.

[email protected]

VANCOUVER – When diabetes is diagnosed from ages 15 to 30 years, type 2 patients are less likely than are type 1 patients to reach their 50th birthday, according to investigators from the University of Sydney.

Even just a few years after diagnosis, young type 2 patients have a worse cardiovascular profile and worse cardiovascular disease, which leads to an earlier death.

“We pay less attention to type 2 than type 1 in young people. They’re not as sick, and don’t develop [diabetic ketoacidosis] if they miss a treatment. But young type 2 is not a milder form of diabetes in young people, and its detrimental impact occurs early. Before we know what’s going on, patients are middle age, and it’s too late,” said investigator Maria Constantino, a Ph.D. candidate, nurse, and diabetes researcher and educator at the University of Sydney.

Screening for type 2 diabetes “should start at a young age in at-risk groups,” and diabetes cardiovascular risk criteria should be reconsidered so that younger type 2 patients aren’t overlooked because of their age. Current criteria likely “lead to delay in preventive treatment” in the young, she said.

The conclusions come from a review of diabetes patients treated since 1990 at the Royal Prince Alfred Hospital in Sydney (Diabetes Care. 2013 Dec; 36[12]:3863-9).

The investigators compared 354 type 2 patients with 470 type 1 patients diagnosed from age 15-30 years. By around the age of 40 years, 11% of the type 2 patients had died, vs. 6.8% with type 1 (hazard ratio, 2.0; 95% confidence interval, 1.2-3.2; P = .003). Strokes, coronary artery disease, and other macrovascular complications were also far more common in the type 2 group, and they had worse hypertension and dyslipidemia despite taking more drugs to combat both. Type 2 patients also had more albuminuria and neuropathy.

The differences occurred despite the fact that type 2 patients smoked less, had a slightly shorter duration of disease (11.6 vs. 14.7 years), and equivalent glycemic control with their type 1 counterparts, with a mean hemoglobin A_1c of 8.1% in both groups. They were heavier, however, with a mean body mass index of 32.2 kg/m² vs. 25.6 kg/m² in type 1 patients.

In short, young-onset type 2 is a “more lethal phenotype of diabetes. We are not saying one type of diabetes is more important; we need to conquer both.” But in young type 2 patients, “we need to focus on more than just glycemic control.” Cardiovascular risk factors are “detectable early, and treatable,” Ms. Constantino said.

The investigators also compared their 354 young-onset type 2 patients with 1,062 patients diagnosed from age 40-50 years.

By the time they were about 50 years old, young-onset patients were 6.5 times more likely to have died than were their age-matched peers without diabetes in the general Australian population. The peak in excess mortality for those diagnosed in their 5th decade came at about age of 65 years, with a risk of death about 2.5 times higher than nondiabetic peers in the general population.

“The impact of type 2 is much higher the younger a person is. You can argue that in our enthusiasm to diagnose diabetes, we are casting our screening net wider and wider, and take pride in diagnosing many elderly patients with diabetes, but we should not lose sight of the fact that finding and treating an elderly person with diabetes has much less impact than finding and treating one in a young age group,” she said.

Ms. Constantino has no conflicts of interest.

[email protected]

Vancouver, B.C. – If a patient is admitted to the hospital with a plasma glucose at or above 140 mg/dL, it’s wise to check the hemoglobin A_1c level to catch undiagnosed diabetes, according to British and Irish researchers.

“A combination of admission plasma glucose and hemoglobin A_1c can be used to diagnose diabetes in acute medicine, provided care is taken when interpreting hemoglobin A_1c results, as they can be affected by various medical conditions or certain drugs,” said investigator Dr. Sandip Ghosh, a diabetologist at Queen Elizabeth Hospital in Birmingham, England.

The conclusion comes from a review of 2,061 white inpatients at University Hospital Waterford (Ireland), 412 (20%) of whom were diagnosed with diabetes on admission or displayed symptoms and complications.

An admission plasma glucose level of 140.4 mg/dL correlated with a hemoglobin A_1c of 6.5%, the threshold for diabetes diagnosis. If ordering a hemoglobin A_{1c is delayed until the plasma glucose reaches 200 mg/dL}, “we are missing an awful lot of people with diabetes,” Dr. Ghosh said.

The linear correlation between admission plasma glucose and hemoglobin A_1c levels wasn’t perfect (r² = 0.63, P less than 0.001). The approach was highly specific but not very sensitive, possibly because of a hemoglobin A_1c level that has been compromised by liver, renal, or other problems, said investigator Susan Manley, Ph.D., a biochemist at the Birmingham hospital.

The Joint British Diabetes Society is planning to release a nationwide guideline for diabetes screening at hospital admission, but the quickest and most cost-effective way to screen for diabetes is uncertain.

Dr. Ghosh and Dr. Manley are both involved with those efforts, and their study is an attempt to solve the problem. They and their colleagues are planning a prospective study of hemoglobin A_1c screening approaches in a more racially diverse population.

Eventually, “we are going to use” these findings to help write the recommendations, but “we need to make sure emergency wards do make the measurements,” and that labs can handle an upsurge in hemoglobin A_1c testing, Dr. Manley said.

For now, hemoglobin A_1c is generally used to check glucose control in hospital patients already known to have diabetes, both in the United Kingdom and the United States. It’s attractive as a hospital screening tool, however, because it can help discriminate between patients who truly have diabetes and those who are hyperglycemic because of acute illness.

The study analyzed admission plasma glucose, hemoglobin A_1c, oral glucose tolerance tests, and other measures in consecutive, short-term medical admissions to the Waterford hospital from 2005 to 2007. The researchers calculated that hemoglobin A_1c screening would have identified about 40 more cases of diabetes.

The authors reported no conflicts of interest.

[email protected]

Vancouver, B.C. – If a patient is admitted to the hospital with a plasma glucose at or above 140 mg/dL, it’s wise to check the hemoglobin A_1c level to catch undiagnosed diabetes, according to British and Irish researchers.

“A combination of admission plasma glucose and hemoglobin A_1c can be used to diagnose diabetes in acute medicine, provided care is taken when interpreting hemoglobin A_1c results, as they can be affected by various medical conditions or certain drugs,” said investigator Dr. Sandip Ghosh, a diabetologist at Queen Elizabeth Hospital in Birmingham, England.

The conclusion comes from a review of 2,061 white inpatients at University Hospital Waterford (Ireland), 412 (20%) of whom were diagnosed with diabetes on admission or displayed symptoms and complications.

An admission plasma glucose level of 140.4 mg/dL correlated with a hemoglobin A_1c of 6.5%, the threshold for diabetes diagnosis. If ordering a hemoglobin A_{1c is delayed until the plasma glucose reaches 200 mg/dL}, “we are missing an awful lot of people with diabetes,” Dr. Ghosh said.

The linear correlation between admission plasma glucose and hemoglobin A_1c levels wasn’t perfect (r² = 0.63, P less than 0.001). The approach was highly specific but not very sensitive, possibly because of a hemoglobin A_1c level that has been compromised by liver, renal, or other problems, said investigator Susan Manley, Ph.D., a biochemist at the Birmingham hospital.

The Joint British Diabetes Society is planning to release a nationwide guideline for diabetes screening at hospital admission, but the quickest and most cost-effective way to screen for diabetes is uncertain.

Dr. Ghosh and Dr. Manley are both involved with those efforts, and their study is an attempt to solve the problem. They and their colleagues are planning a prospective study of hemoglobin A_1c screening approaches in a more racially diverse population.

Eventually, “we are going to use” these findings to help write the recommendations, but “we need to make sure emergency wards do make the measurements,” and that labs can handle an upsurge in hemoglobin A_1c testing, Dr. Manley said.

For now, hemoglobin A_1c is generally used to check glucose control in hospital patients already known to have diabetes, both in the United Kingdom and the United States. It’s attractive as a hospital screening tool, however, because it can help discriminate between patients who truly have diabetes and those who are hyperglycemic because of acute illness.

The study analyzed admission plasma glucose, hemoglobin A_1c, oral glucose tolerance tests, and other measures in consecutive, short-term medical admissions to the Waterford hospital from 2005 to 2007. The researchers calculated that hemoglobin A_1c screening would have identified about 40 more cases of diabetes.

The authors reported no conflicts of interest.

[email protected]

Vancouver, B.C. – If a patient is admitted to the hospital with a plasma glucose at or above 140 mg/dL, it’s wise to check the hemoglobin A_1c level to catch undiagnosed diabetes, according to British and Irish researchers.

“A combination of admission plasma glucose and hemoglobin A_1c can be used to diagnose diabetes in acute medicine, provided care is taken when interpreting hemoglobin A_1c results, as they can be affected by various medical conditions or certain drugs,” said investigator Dr. Sandip Ghosh, a diabetologist at Queen Elizabeth Hospital in Birmingham, England.

The conclusion comes from a review of 2,061 white inpatients at University Hospital Waterford (Ireland), 412 (20%) of whom were diagnosed with diabetes on admission or displayed symptoms and complications.

An admission plasma glucose level of 140.4 mg/dL correlated with a hemoglobin A_1c of 6.5%, the threshold for diabetes diagnosis. If ordering a hemoglobin A_{1c is delayed until the plasma glucose reaches 200 mg/dL}, “we are missing an awful lot of people with diabetes,” Dr. Ghosh said.

The linear correlation between admission plasma glucose and hemoglobin A_1c levels wasn’t perfect (r² = 0.63, P less than 0.001). The approach was highly specific but not very sensitive, possibly because of a hemoglobin A_1c level that has been compromised by liver, renal, or other problems, said investigator Susan Manley, Ph.D., a biochemist at the Birmingham hospital.

The Joint British Diabetes Society is planning to release a nationwide guideline for diabetes screening at hospital admission, but the quickest and most cost-effective way to screen for diabetes is uncertain.

Dr. Ghosh and Dr. Manley are both involved with those efforts, and their study is an attempt to solve the problem. They and their colleagues are planning a prospective study of hemoglobin A_1c screening approaches in a more racially diverse population.

Eventually, “we are going to use” these findings to help write the recommendations, but “we need to make sure emergency wards do make the measurements,” and that labs can handle an upsurge in hemoglobin A_1c testing, Dr. Manley said.

For now, hemoglobin A_1c is generally used to check glucose control in hospital patients already known to have diabetes, both in the United Kingdom and the United States. It’s attractive as a hospital screening tool, however, because it can help discriminate between patients who truly have diabetes and those who are hyperglycemic because of acute illness.

The study analyzed admission plasma glucose, hemoglobin A_1c, oral glucose tolerance tests, and other measures in consecutive, short-term medical admissions to the Waterford hospital from 2005 to 2007. The researchers calculated that hemoglobin A_1c screening would have identified about 40 more cases of diabetes.

The authors reported no conflicts of interest.

[email protected]

The Food and Drug Administration on Dec. 16 approved Lilly’s Basaglar (insulin glargine injection 100 unit/mL), a long-acting human insulin analog that will compete with Sanofi’s blockbuster Lantus.

Basaglar received tentative approval in 2014, but final approval was held up until the two companies settled a Sanofi lawsuit in September of 2015 that claimed patent infringement on the pen formulation of Lantus. Basaglar will now also have a pen option.

U.S. pricing information hasn’t been released, but in Europe, where Basaglar is already on the market, the pen formulation costs about 15% less than Lantus pens.

The approval was based, in part, on the FDA’s confidence in Lantus, which was approved in 2000. “The applicant demonstrated that Basaglar was sufficiently similar to Lantus to scientifically justify” approval, “and also provided Basaglar-specific data to establish the drug’s safety and efficacy for its approved uses. The Basaglar-specific data included two clinical trials enrolling 534 and 744 patients with type 1 and 2 diabetes mellitus, respectively,” the agency said in a statement.

Basaglar carries the same indications as Lantus to improve glycemic control in adults and children with type 1 diabetes and adults with type 2 diabetes. The agency said Basaglar is meant to be administered once daily at the same time every day. Lantus carries that dosing recommendation, but physicians have come to realize that its duration of action varies, and some now prefer a split dose with two daily injections, believing it provides tighter glycemic control.

“Long-acting insulin products like insulin glargine play an important role in the treatment of types 1 and 2 diabetes mellitus, and today’s approval is expected to expand the availability of treatment options for health care professionals and patients,” Dr. Jean-Marc Guettier, director of the FDA’s Division of Metabolism and Endocrinology Products, said in the agency statement.

Like any insulin, Basaglar can cause life-threatening hypoglycemia, and life-threatening allergic reactions, including anaphylaxis.

Also as with any insulin, the agency noted, Basaglar should not be used during episodes of hypoglycemia, and patients should be monitored more closely when there are “changes to insulin dosage, co-administration of other glucose-lowering medications, meal pattern, physical activity and in patients with renal impairment or hepatic impairment or hypoglycemia unawareness.”

Adverse reactions in trials were generally the same as with Lantus, and included hypoglycemia, allergic reactions, injection site reactions, injection site pitting, itching, rash, edema, and weight gain.

Although considered a Lantus biosimilar by some, the FDA noted that “Basaglar is not approved as a biosimilar product. No insulin glargine products are currently licensed under the Public Health Service Act, so there is no reference product for a proposed biosimilar product.”

[email protected]

The Food and Drug Administration on Dec. 16 approved Lilly’s Basaglar (insulin glargine injection 100 unit/mL), a long-acting human insulin analog that will compete with Sanofi’s blockbuster Lantus.

Basaglar received tentative approval in 2014, but final approval was held up until the two companies settled a Sanofi lawsuit in September of 2015 that claimed patent infringement on the pen formulation of Lantus. Basaglar will now also have a pen option.

U.S. pricing information hasn’t been released, but in Europe, where Basaglar is already on the market, the pen formulation costs about 15% less than Lantus pens.

The approval was based, in part, on the FDA’s confidence in Lantus, which was approved in 2000. “The applicant demonstrated that Basaglar was sufficiently similar to Lantus to scientifically justify” approval, “and also provided Basaglar-specific data to establish the drug’s safety and efficacy for its approved uses. The Basaglar-specific data included two clinical trials enrolling 534 and 744 patients with type 1 and 2 diabetes mellitus, respectively,” the agency said in a statement.

Basaglar carries the same indications as Lantus to improve glycemic control in adults and children with type 1 diabetes and adults with type 2 diabetes. The agency said Basaglar is meant to be administered once daily at the same time every day. Lantus carries that dosing recommendation, but physicians have come to realize that its duration of action varies, and some now prefer a split dose with two daily injections, believing it provides tighter glycemic control.

“Long-acting insulin products like insulin glargine play an important role in the treatment of types 1 and 2 diabetes mellitus, and today’s approval is expected to expand the availability of treatment options for health care professionals and patients,” Dr. Jean-Marc Guettier, director of the FDA’s Division of Metabolism and Endocrinology Products, said in the agency statement.

Like any insulin, Basaglar can cause life-threatening hypoglycemia, and life-threatening allergic reactions, including anaphylaxis.

Also as with any insulin, the agency noted, Basaglar should not be used during episodes of hypoglycemia, and patients should be monitored more closely when there are “changes to insulin dosage, co-administration of other glucose-lowering medications, meal pattern, physical activity and in patients with renal impairment or hepatic impairment or hypoglycemia unawareness.”

Adverse reactions in trials were generally the same as with Lantus, and included hypoglycemia, allergic reactions, injection site reactions, injection site pitting, itching, rash, edema, and weight gain.

Although considered a Lantus biosimilar by some, the FDA noted that “Basaglar is not approved as a biosimilar product. No insulin glargine products are currently licensed under the Public Health Service Act, so there is no reference product for a proposed biosimilar product.”

[email protected]

The Food and Drug Administration on Dec. 16 approved Lilly’s Basaglar (insulin glargine injection 100 unit/mL), a long-acting human insulin analog that will compete with Sanofi’s blockbuster Lantus.

Basaglar received tentative approval in 2014, but final approval was held up until the two companies settled a Sanofi lawsuit in September of 2015 that claimed patent infringement on the pen formulation of Lantus. Basaglar will now also have a pen option.

U.S. pricing information hasn’t been released, but in Europe, where Basaglar is already on the market, the pen formulation costs about 15% less than Lantus pens.

The approval was based, in part, on the FDA’s confidence in Lantus, which was approved in 2000. “The applicant demonstrated that Basaglar was sufficiently similar to Lantus to scientifically justify” approval, “and also provided Basaglar-specific data to establish the drug’s safety and efficacy for its approved uses. The Basaglar-specific data included two clinical trials enrolling 534 and 744 patients with type 1 and 2 diabetes mellitus, respectively,” the agency said in a statement.

Basaglar carries the same indications as Lantus to improve glycemic control in adults and children with type 1 diabetes and adults with type 2 diabetes. The agency said Basaglar is meant to be administered once daily at the same time every day. Lantus carries that dosing recommendation, but physicians have come to realize that its duration of action varies, and some now prefer a split dose with two daily injections, believing it provides tighter glycemic control.

“Long-acting insulin products like insulin glargine play an important role in the treatment of types 1 and 2 diabetes mellitus, and today’s approval is expected to expand the availability of treatment options for health care professionals and patients,” Dr. Jean-Marc Guettier, director of the FDA’s Division of Metabolism and Endocrinology Products, said in the agency statement.

Like any insulin, Basaglar can cause life-threatening hypoglycemia, and life-threatening allergic reactions, including anaphylaxis.

Also as with any insulin, the agency noted, Basaglar should not be used during episodes of hypoglycemia, and patients should be monitored more closely when there are “changes to insulin dosage, co-administration of other glucose-lowering medications, meal pattern, physical activity and in patients with renal impairment or hepatic impairment or hypoglycemia unawareness.”

Adverse reactions in trials were generally the same as with Lantus, and included hypoglycemia, allergic reactions, injection site reactions, injection site pitting, itching, rash, edema, and weight gain.

Although considered a Lantus biosimilar by some, the FDA noted that “Basaglar is not approved as a biosimilar product. No insulin glargine products are currently licensed under the Public Health Service Act, so there is no reference product for a proposed biosimilar product.”

[email protected]

VANCOUVER, B.C. – So far, just one of the newer diabetes drugs has been shown to cut cardiovascular risk in type 2 diabetes.

Dr. Bernard Zinman, chairman of the meeting’s program committee, explained which one it is, and also shared other highlights from this year’s World Diabetes Congress.

In an interview at the meeting, Dr. Zinman offered new insights on beta-cell preservation, diabetes prevention, pancreas imaging, the microbiome, and the best combination therapies for early intervention.

“Diabetes is a very complex disease,” said Dr. Zinman, also the director of the diabetes center at Mount Sinai Hospital in Toronto and a professor of medicine at the University of Toronto. “To imagine that there’s one therapy or one magic bullet” that’s going to take care of all the problems in diabetes, “is very naive.”

[email protected]

VANCOUVER, B.C. – So far, just one of the newer diabetes drugs has been shown to cut cardiovascular risk in type 2 diabetes.

Dr. Bernard Zinman, chairman of the meeting’s program committee, explained which one it is, and also shared other highlights from this year’s World Diabetes Congress.

In an interview at the meeting, Dr. Zinman offered new insights on beta-cell preservation, diabetes prevention, pancreas imaging, the microbiome, and the best combination therapies for early intervention.

“Diabetes is a very complex disease,” said Dr. Zinman, also the director of the diabetes center at Mount Sinai Hospital in Toronto and a professor of medicine at the University of Toronto. “To imagine that there’s one therapy or one magic bullet” that’s going to take care of all the problems in diabetes, “is very naive.”

[email protected]

VANCOUVER, B.C. – So far, just one of the newer diabetes drugs has been shown to cut cardiovascular risk in type 2 diabetes.

Dr. Bernard Zinman, chairman of the meeting’s program committee, explained which one it is, and also shared other highlights from this year’s World Diabetes Congress.

In an interview at the meeting, Dr. Zinman offered new insights on beta-cell preservation, diabetes prevention, pancreas imaging, the microbiome, and the best combination therapies for early intervention.

“Diabetes is a very complex disease,” said Dr. Zinman, also the director of the diabetes center at Mount Sinai Hospital in Toronto and a professor of medicine at the University of Toronto. “To imagine that there’s one therapy or one magic bullet” that’s going to take care of all the problems in diabetes, “is very naive.”

[email protected]

VANCOUVER, B.C. – If patients haven’t lost 5% or more of their body weight after 16 weeks on liraglutide at a daily dose of 3 mg, the drug’s not going to work for weight loss and should be stopped, according to findings from a study by Novo Nordisk, the maker of liraglutide, that was presented at the World Diabetes Congress.

The 3-mg dose is marketed for weight loss as Saxenda; the drug is also sold as Victoza for type 2 diabetes at a dose of up to 1.8 mg.

The findings come from a new analysis of Novo Nordisk’s SCALE study, which included diet and exercise along with liraglutide 3 mg. About two-thirds of obese and prediabetic patients, versus about a third of patients on placebo, responded early to the 3-mg dose, losing 5% or more of their weight by week 16. By week 56, they had a mean weight loss of 11.5%. About half of patients with type 2 diabetes were early responders; they lost a mean of 9.3% at week 56. Nonresponders lost about 3.7% of their body weight after 56 weeks. Rates of hepatobiliary disorders with liraglutide were highest in nondiabetic subjects, at 3.5% (N Engl J Med. 2015 Jul 2;373[1]:11-22).

In an interview at the meeting, investigator Dr. Matthias Blüher, an endocrinology professor at the University of Leipzig (Germany), explained how to make use of the findings.

[email protected]

VANCOUVER, B.C. – If patients haven’t lost 5% or more of their body weight after 16 weeks on liraglutide at a daily dose of 3 mg, the drug’s not going to work for weight loss and should be stopped, according to findings from a study by Novo Nordisk, the maker of liraglutide, that was presented at the World Diabetes Congress.

The 3-mg dose is marketed for weight loss as Saxenda; the drug is also sold as Victoza for type 2 diabetes at a dose of up to 1.8 mg.

The findings come from a new analysis of Novo Nordisk’s SCALE study, which included diet and exercise along with liraglutide 3 mg. About two-thirds of obese and prediabetic patients, versus about a third of patients on placebo, responded early to the 3-mg dose, losing 5% or more of their weight by week 16. By week 56, they had a mean weight loss of 11.5%. About half of patients with type 2 diabetes were early responders; they lost a mean of 9.3% at week 56. Nonresponders lost about 3.7% of their body weight after 56 weeks. Rates of hepatobiliary disorders with liraglutide were highest in nondiabetic subjects, at 3.5% (N Engl J Med. 2015 Jul 2;373[1]:11-22).

In an interview at the meeting, investigator Dr. Matthias Blüher, an endocrinology professor at the University of Leipzig (Germany), explained how to make use of the findings.

[email protected]

VANCOUVER, B.C. – If patients haven’t lost 5% or more of their body weight after 16 weeks on liraglutide at a daily dose of 3 mg, the drug’s not going to work for weight loss and should be stopped, according to findings from a study by Novo Nordisk, the maker of liraglutide, that was presented at the World Diabetes Congress.

The 3-mg dose is marketed for weight loss as Saxenda; the drug is also sold as Victoza for type 2 diabetes at a dose of up to 1.8 mg.

The findings come from a new analysis of Novo Nordisk’s SCALE study, which included diet and exercise along with liraglutide 3 mg. About two-thirds of obese and prediabetic patients, versus about a third of patients on placebo, responded early to the 3-mg dose, losing 5% or more of their weight by week 16. By week 56, they had a mean weight loss of 11.5%. About half of patients with type 2 diabetes were early responders; they lost a mean of 9.3% at week 56. Nonresponders lost about 3.7% of their body weight after 56 weeks. Rates of hepatobiliary disorders with liraglutide were highest in nondiabetic subjects, at 3.5% (N Engl J Med. 2015 Jul 2;373[1]:11-22).

In an interview at the meeting, investigator Dr. Matthias Blüher, an endocrinology professor at the University of Leipzig (Germany), explained how to make use of the findings.

[email protected]

VANCOUVER – At least one of the commercially available energy drinks plays havoc with blood sugar and insulin levels in teen users, according to research from the University of Calgary (Alta.).

Ten teenage boys and ten girls were randomized to one regular “5-hour energy” drink, or, as a control, the decaffeinated version of the product, and then given an oral glucose tolerance test 40 minutes later.

In the second phase, the kids switched over to the drink they didn’t get in the first go-round, and the tolerance testing was repeated. Blood testing was done at baseline and throughout the study.

Investigator Jane Shearer, Ph.D., of the university’s department of biochemistry and molecular biology, explained the results, and why she’s worried about them, in an interview at the World Diabetes Congress.

Five-hour energy is a sugar-free 2-ounce drink containing about 200 mg of caffeine in its regular-strength formulation.

The findings raise another red flag about energy drinks in kids, especially if they are prone to diabetes. Dr. Shearer also shared her thoughts on what to do to address the issue.

[email protected]

VANCOUVER – At least one of the commercially available energy drinks plays havoc with blood sugar and insulin levels in teen users, according to research from the University of Calgary (Alta.).

Ten teenage boys and ten girls were randomized to one regular “5-hour energy” drink, or, as a control, the decaffeinated version of the product, and then given an oral glucose tolerance test 40 minutes later.

In the second phase, the kids switched over to the drink they didn’t get in the first go-round, and the tolerance testing was repeated. Blood testing was done at baseline and throughout the study.

Investigator Jane Shearer, Ph.D., of the university’s department of biochemistry and molecular biology, explained the results, and why she’s worried about them, in an interview at the World Diabetes Congress.

Five-hour energy is a sugar-free 2-ounce drink containing about 200 mg of caffeine in its regular-strength formulation.

The findings raise another red flag about energy drinks in kids, especially if they are prone to diabetes. Dr. Shearer also shared her thoughts on what to do to address the issue.

[email protected]

VANCOUVER – At least one of the commercially available energy drinks plays havoc with blood sugar and insulin levels in teen users, according to research from the University of Calgary (Alta.).

Ten teenage boys and ten girls were randomized to one regular “5-hour energy” drink, or, as a control, the decaffeinated version of the product, and then given an oral glucose tolerance test 40 minutes later.

In the second phase, the kids switched over to the drink they didn’t get in the first go-round, and the tolerance testing was repeated. Blood testing was done at baseline and throughout the study.

Investigator Jane Shearer, Ph.D., of the university’s department of biochemistry and molecular biology, explained the results, and why she’s worried about them, in an interview at the World Diabetes Congress.

Five-hour energy is a sugar-free 2-ounce drink containing about 200 mg of caffeine in its regular-strength formulation.

The findings raise another red flag about energy drinks in kids, especially if they are prone to diabetes. Dr. Shearer also shared her thoughts on what to do to address the issue.

[email protected]

VANCOUVER, B.C. – Transitioning to adult diabetes care tripled hospital admissions for diabetic ketoacidosis in a Canadian study of 147 patients at Western University in London, Ont.

The number of diabetic ketoacidosis (DKA) admissions and emergency department visits for hypoglycemia or hyperglycemia increased from 65 during the 3 years before the subjects turned 18 to 101 during the 3 years afterward.

There were other problems, too. Mean hemoglobin A_1c increased from 8.66 % to 8.89% after transition to adult care, and urine albumin creatinine ratio (ACR) testing decreased, with 47 patients (32%) tested at least once before transition, but 29 (20%) afterward.

“Some would say that these are teenagers, and they’ll are grow out of” it as they learn how to care for themselves as adults, “but I don’t think that’s good enough” because there’s an increased risk of acute complications. “The transition period is associated with worsening glycemic control and an increased risk of DKA admission. There is room for improved screening, as well. I think there is certainly a role for intervention,” said Dr. Jennifer Huynh, chief resident in internal medicine at Western University.

The differences in HbA_1care big enough to worry about. “We know when A_1c is high, even small increases or decreases” make a difference. Meanwhile, the increased risk of DKA (odds ratio, 3; 95% confidence interval, 1.19-7.5) is “very concerning,” she said at the World Diabetes Congress.

It’s been reported before that children with diabetes run into trouble when they move into adult care; the findings are a reminder of the issue, and help firm up the extent of the problem. The investigators were able to do a robust comparison of pre- and posttransition patients because the database at Western University links patients’ pediatric and adult records.

What often happens is that diabetes takes a backseat to school, work, relationships, and other pressures of emerging adulthood, and parents are no longer around to make sure kids take care of themselves. Given all that’s going on, it’s not surprising that the researchers also found there were 1,149 office visits in the 3 years before the subjects turned 18, but only 750 in the 3 years afterward.

All but three of the young adults in the study had type 1 diabetes, and just over half were women. At the baseline visit at 15 years of age, the median duration of diabetes was 5 years, mean weight was 66.4 kg, and the mean body mass index was 23.5 kg/m^2. Forty-five subjects (31%) were on an insulin pump, 96 (65%) were on multiple daily injections, 3 (2%) were on premixed insulin, and 3 (2%) took oral agents.

Researchers at Western University and elsewhere are putting a lot of effort into figuring out how to improve the situation. Special transition clinics, support groups, and social media campaigns are just some of what’s being tried.

Investigators from Western University are finishing up a randomized trial to see if a transition coordinator helps. Patients were randomized to usual care or care overseen by the coordinator, a certified diabetes educator.

The coordinator stays in touch with the teenagers, sends them test results, reminds them of appointments for lab work and office visits, and, in general, serves as a sounding board, guide, and friend to help them manage the transition into adult care.

The hope is that the efforts will improves clinic attendance and glycemic control, among other things.

Western University is considering a survey of transition programs in Canada, to find out what works so “we can make some recommendations in terms of policy,” Dr. Huynh said.

The investigators have no conflicts of interest, and there was no industry funding for the work.

[email protected]

VANCOUVER, B.C. – Transitioning to adult diabetes care tripled hospital admissions for diabetic ketoacidosis in a Canadian study of 147 patients at Western University in London, Ont.

The number of diabetic ketoacidosis (DKA) admissions and emergency department visits for hypoglycemia or hyperglycemia increased from 65 during the 3 years before the subjects turned 18 to 101 during the 3 years afterward.

There were other problems, too. Mean hemoglobin A_1c increased from 8.66 % to 8.89% after transition to adult care, and urine albumin creatinine ratio (ACR) testing decreased, with 47 patients (32%) tested at least once before transition, but 29 (20%) afterward.

“Some would say that these are teenagers, and they’ll are grow out of” it as they learn how to care for themselves as adults, “but I don’t think that’s good enough” because there’s an increased risk of acute complications. “The transition period is associated with worsening glycemic control and an increased risk of DKA admission. There is room for improved screening, as well. I think there is certainly a role for intervention,” said Dr. Jennifer Huynh, chief resident in internal medicine at Western University.

The differences in HbA_1care big enough to worry about. “We know when A_1c is high, even small increases or decreases” make a difference. Meanwhile, the increased risk of DKA (odds ratio, 3; 95% confidence interval, 1.19-7.5) is “very concerning,” she said at the World Diabetes Congress.

It’s been reported before that children with diabetes run into trouble when they move into adult care; the findings are a reminder of the issue, and help firm up the extent of the problem. The investigators were able to do a robust comparison of pre- and posttransition patients because the database at Western University links patients’ pediatric and adult records.

What often happens is that diabetes takes a backseat to school, work, relationships, and other pressures of emerging adulthood, and parents are no longer around to make sure kids take care of themselves. Given all that’s going on, it’s not surprising that the researchers also found there were 1,149 office visits in the 3 years before the subjects turned 18, but only 750 in the 3 years afterward.

All but three of the young adults in the study had type 1 diabetes, and just over half were women. At the baseline visit at 15 years of age, the median duration of diabetes was 5 years, mean weight was 66.4 kg, and the mean body mass index was 23.5 kg/m^2. Forty-five subjects (31%) were on an insulin pump, 96 (65%) were on multiple daily injections, 3 (2%) were on premixed insulin, and 3 (2%) took oral agents.

Researchers at Western University and elsewhere are putting a lot of effort into figuring out how to improve the situation. Special transition clinics, support groups, and social media campaigns are just some of what’s being tried.

Investigators from Western University are finishing up a randomized trial to see if a transition coordinator helps. Patients were randomized to usual care or care overseen by the coordinator, a certified diabetes educator.

The coordinator stays in touch with the teenagers, sends them test results, reminds them of appointments for lab work and office visits, and, in general, serves as a sounding board, guide, and friend to help them manage the transition into adult care.

The hope is that the efforts will improves clinic attendance and glycemic control, among other things.

Western University is considering a survey of transition programs in Canada, to find out what works so “we can make some recommendations in terms of policy,” Dr. Huynh said.

The investigators have no conflicts of interest, and there was no industry funding for the work.

[email protected]

VANCOUVER, B.C. – Transitioning to adult diabetes care tripled hospital admissions for diabetic ketoacidosis in a Canadian study of 147 patients at Western University in London, Ont.

The number of diabetic ketoacidosis (DKA) admissions and emergency department visits for hypoglycemia or hyperglycemia increased from 65 during the 3 years before the subjects turned 18 to 101 during the 3 years afterward.

There were other problems, too. Mean hemoglobin A_1c increased from 8.66 % to 8.89% after transition to adult care, and urine albumin creatinine ratio (ACR) testing decreased, with 47 patients (32%) tested at least once before transition, but 29 (20%) afterward.

“Some would say that these are teenagers, and they’ll are grow out of” it as they learn how to care for themselves as adults, “but I don’t think that’s good enough” because there’s an increased risk of acute complications. “The transition period is associated with worsening glycemic control and an increased risk of DKA admission. There is room for improved screening, as well. I think there is certainly a role for intervention,” said Dr. Jennifer Huynh, chief resident in internal medicine at Western University.

The differences in HbA_1care big enough to worry about. “We know when A_1c is high, even small increases or decreases” make a difference. Meanwhile, the increased risk of DKA (odds ratio, 3; 95% confidence interval, 1.19-7.5) is “very concerning,” she said at the World Diabetes Congress.

It’s been reported before that children with diabetes run into trouble when they move into adult care; the findings are a reminder of the issue, and help firm up the extent of the problem. The investigators were able to do a robust comparison of pre- and posttransition patients because the database at Western University links patients’ pediatric and adult records.

What often happens is that diabetes takes a backseat to school, work, relationships, and other pressures of emerging adulthood, and parents are no longer around to make sure kids take care of themselves. Given all that’s going on, it’s not surprising that the researchers also found there were 1,149 office visits in the 3 years before the subjects turned 18, but only 750 in the 3 years afterward.

All but three of the young adults in the study had type 1 diabetes, and just over half were women. At the baseline visit at 15 years of age, the median duration of diabetes was 5 years, mean weight was 66.4 kg, and the mean body mass index was 23.5 kg/m^2. Forty-five subjects (31%) were on an insulin pump, 96 (65%) were on multiple daily injections, 3 (2%) were on premixed insulin, and 3 (2%) took oral agents.

Researchers at Western University and elsewhere are putting a lot of effort into figuring out how to improve the situation. Special transition clinics, support groups, and social media campaigns are just some of what’s being tried.

Investigators from Western University are finishing up a randomized trial to see if a transition coordinator helps. Patients were randomized to usual care or care overseen by the coordinator, a certified diabetes educator.

The coordinator stays in touch with the teenagers, sends them test results, reminds them of appointments for lab work and office visits, and, in general, serves as a sounding board, guide, and friend to help them manage the transition into adult care.

The hope is that the efforts will improves clinic attendance and glycemic control, among other things.

Western University is considering a survey of transition programs in Canada, to find out what works so “we can make some recommendations in terms of policy,” Dr. Huynh said.

The investigators have no conflicts of interest, and there was no industry funding for the work.

[email protected]