News Feature | September 8, 2014

Lilly's Peglispro Superior To Lantus In Phase 3 Trials

By Estel Grace Masangkay

Eli Lilly & Co. reported that its basal insulin peglispro (BIL) demonstrated superiority to insulin glargine, Lantus, in the Phase III trials IMAGINE-1 and IMAGINE-3 for patients with Type 1 diabetes.

Basal insulin peglispro was discovered in Lilly Research Laboratories and is currently under Phase III development for the treatment of both Type 1 and Type 2 diabetes. In the Phase III IMAGINE trials, the drug showed consistent superiority in lowering hemoglobin A1c (HbA1c) compared to Sanofi’s Lantus.

Enrique Conterno, President of Lilly Diabetes, said, “These data are promising and give us further confidence in the clinical profile of BIL… If approved, we believe BIL will be an important new basal insulin option for people with diabetes.”

In both trials, the rate of nocturnal hypoglycemia was markedly lower in patients treated with BIL than in patients who took insulin glargine. However, more injection site reactions were observed in the former group taking BIL compared with the latter. A statistically significant difference in weight was also noted; patients taking BIL experienced weight loss in spite of lower HbA1c compared to those who were taking insulin glargine and gaining weight.

“All patients with type 1 diabetes depend on insulin to achieve and maintain their target blood glucose levels. For a number of those patients, current insulin options may not be optimal — particularly in those who experience nocturnal hypoglycemia or weight gain. Basal insulin peglispro may offer a useful option to help address these challenges,” said David Kendall, VP of Medical Affairs at Lilly Diabetes.

Peglispro had been already noted for its superiority to Lantus in earlier trials. In May, the drug was shown to be better than insulin glargine in reducing blood sugar levels of patients in three late-stage trials.

Lilly said it expects to announced detailed study results from all IMAGINE Phase III clinical trials next year. The company also intends to submit BIL for U.S. Food and Drug Administration (FDA) and European Medicines Agency (EMA) regulatory reviews by the end of the first quarter of 2015. Sanofi’s Lantus, currently the most prescribed insulin drug in the world and worth $2 billion in quarterly sales, will lose its U.S. patent in the same period.