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Insulin degludec 200 U/mL delivers larger doses safely, effectively
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PHILADELPHIA — The 200-U/mL formulation of insulin degludec allowed for delivery of larger insulin doses in a single injection while still safely and effectively improving glycemic control, new data suggest.
Richard Bergenstal, MD, executive director of the International Diabetes Center at Park Nicollet in Minneapolis, Minn., and past-president of medicine and science at the American Diabetes Association, noted that obesity is a significant problem, especially in the United States, and contributes to the need for larger daily doses of insulin in patients with type 2 diabetes.
“We saw that there were a substantial number of people who required over 80 U of basal insulin, and some even required over 100 U of basal insulin, particularly in the United States,” he said during a presentation.
Insulin degludec 200 U/mL delivers twice the amount of insulin — up to 160 U — in the same volume as the 100 U/mL formulation. To evaluate the safety of the concentrated formulation, Bergenstal and colleagues conducted a trial in insulin-naïve patients with type 2 diabetes comparing insulin degludec 200 U/mL with insulin glargine.
Patients were randomly assigned insulin degludec 200 U/mL or insulin glargine in combination with metformin.
At 26 weeks, insulin degludec decreased HbA1c by 1.3% and was well-tolerated. The average observed fasting plasma glucose reductions were more impressive with insulin degludec compared with insulin glargine (P=.02), according to the researchers. Hypoglycemia rates were also lower with insulin degludec (P=.46).
“We studied the 200 U/mL formulation [of insulin degludec], half the volume as delivered in the U100, to try to address that ever increasing need for large doses of insulin in our increasingly obese population. There was a similar improvement in the HbA1c, a slightly better improvement in the fasting glucose, with quite a bit lower, but not statistically significant, risk for hypoglycemia,” Bergenstal said. – by Samantha Costa
For more information:
Bergenstal, R. Abstract #207. Presented at: the American Association of Clinical Endocrinologists 21st Annual Scientific and Clinical Congress Meeting; May 23-27, 2012; Philadelphia.
Disclosure: Dr Bergenstal conducts clinical research for Novo Nordisk, Eli Lilly and Sanofi, and consults or is on an advisory board for Eli Lilly, Novo Nordisk and Sanofi. He receives no personal compensation for any of these activities. All contracts are with his employer the non-profit Park Nicollet Institute.
Perspective
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George Grunberger, MD
A major issue we have had with our overweight and obese patients with type 2 diabetes, is the huge demand for insulin due to the obesity and insulin resistance. The challenge we have had is that, outside of the Regular U500 formulation, we do not have any other concentrated insulin. The challenge of administering a large volume of insulin has been a big problem, and in many cases, what happens is both the clinicians and patients shy away from aggressive titration just because of the volume and thus not active optimal glucose levels. Having more options for concentrated insulin is an answer to some of my prayers. Even if you do not show that it is a "better" insulin, just the benefit of the administration of a larger dose in a smaller volume, whether it’s the perception or the reality, is you might get better control. I think that introduction of a U-200 formulation is very important for our clinical practice. Unless we shrink the size of our patients, we need to somehow increase the concentration of insulin, and as long as you show there is no harm with this formulation, it’s terrific first step to achieve better glycemic control.
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