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Insulin, GLP-1 Combination Therapy Results

A new combination of long-acting insulin plus a GLP-1 compound is in phase 3 trials and the results are outstanding….

IDegLira, a fixed-ratio combination of insulin degludec and the glucagon like peptide-1 agonist liraglutide, outperformed each medication alone in a 26 week pivotal phase III clinical trial. Patients on IDegLira averaged a 1.91% drop to an HbA1c of 6.4%, compared to1.44% drop to 6.9% with insulin degludec and the 1.28% reduction to an HbA1c of 7.0% with liraglutide. In addition, the IDegLira group fared significantly better in terms of 32% lower rate of hypoglycemic events compared to the insulin degludec group.

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John Buse, MD, PhD, from the University of North Carolina, Chapel Hill, reported the findings from a large 3-arm, open-label, phase 3 trial comparing this combination product with the individual components alone, insulin degludec (Tresiba) or 1.8 mg of liraglutide (Victoza), in 1663 type 2 diabetes patients inadequately controlled on metformin with or without pioglitazone. IDegLira and insulin degludec were titrated to the same fasting glucose (72 – 90 mg/dL).

The primary end point, HbA1c at 26 weeks, decreased by 1.9% from 8.3% to 6.4% with IDegLira, which was greater than the reduction seen with insulin degludec (-1.4%) or liraglutide (-1.3%) alone.

Dr. Buse stated that, “The efficacy [of IDegLira] in lowering glucose was absolutely spectacular, a 1.9% reduction in A1c.” “But the more interesting thing is that many of the aspects of GLP-1 receptor agonists and insulin are complementary.

“So when you titrate up this combination slowly, there’s much less nausea, less than half of what you see with Victoza, despite an even lower A1c, a third less hypoglycemia than you see with insulin alone, and as opposed to weight gain, weight neutrality, just a hint of weight loss, at 26 weeks, so in my mind this is a demonstration of a sort-of souped-up insulin — I hate to say it, but ‘insulin on steroids.’ ”

Dr. Buse said Novo Nordisk plans to file for approval of this combination product in Europe and will report on another version at the International Diabetes Federation meeting in Melbourne, in December. The results were impressive but the FDA has refused to approve until more studies are done proving its safety.

Presented at ADA June, 2013