Phase 3 trial: Basal insulin peglispro lowered HbA1c more than insulin glargine

Patients with type 1 diabetes already taking mealtime insulin reduced their HbA1c more with basal insulin peglispro than insulin glargine in phase 3 clinical trials, according to a press release by Eli Lilly and Company.

The basal insulin peglispro exceeded primary efficacy endpoints at 26 weeks and 52 weeks, respectively, in the IMAGINE-1 and IMAGINE-3 trials compared with insulin glargine (Lantus, Sanofi), according to the release.

Significantly more patients reached the American Diabetes Association glycemic control target of HbA1c <7% with basal insulin peglispro than insulin glargine, according to the release. Further, nocturnal hypoglycemia was lower in patients treated with the Lilly therapeutic.

“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,” David Kendall, MD, vice president, Medical Affairs, Lilly Diabetes, said in the release. “Basal insulin peglispro may offer a useful option to help address these challenges.”

The rate of total hypoglycemia with basal insulin peglispro was higher compared with insulin glargine due to more daytime hypoglycemic events, according to the statement.

Patients treated with basal insulin peglispro achieved weight loss in both trials, compared with weight gain with insulin glargine. Further, small but statistically significant improvements were observed in triglycerides.

Consistent superiority for HbA1c with basal insulin peglispro was also demonstrated in patients with type 1 and type 2 diabetes in all phase 3 trials conducted against competition therapies, according to the statement.

The findings fulfill FDA requirements for drug submission and puts Lilly on track to file with regulators in early 2015.