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GEN News Highlights : Sep 16, 2011

Phase IIIb Study Shows Benefits of Combining Onglyza with Insulin for Type 2 Diabetes

BMS and AstraZeneca say 52-week data showed dipeptidyl peptidase-4 (DPP-4) plus insulin therapy sustained reductions in HbA1c.

Partners Bristol-Myers Squibb and AstraZeneca reported positive data from a Phase IIIb study evaluating the addition of the dipeptidyl peptidase-4 (DPP-4) inhibitor Onglyza™ (saxagliptin) to ongoing insulin therapy (with or without metformin) in adult patients with type II diabetes. Onglyza is currently approved in major markets including the U.S. and Europe for improving glycemic control either in combination with metformin, sulphonylurea, or a thiazolidinedione. Approval has yet to be granted for the use of the drug in combination with insulin, though.

The latest trial results included data from the extension of a 24-week Phase IIIb trial. The 52-week analysis showed that the change from baseline in HbA1c levels among patients taking Onglyza added to insulin (with or without metformin) was -0.75% compared with -0.38% among patients who received placebo instead of Onglyza. Of the 455 patients involved in the original 24-week study, 371 completed the extension phase.

“Since many patients with type 2 diabetes will eventually require insulin, it is important to assess a compound’s ability to be used in combination with insulin to manage blood glucose control over the long term," comments Anthony Barnett, M.D., of the University of Birmingham and Heart of England NHS Foundation Trust, who is principal investigator for the trial. “This is the first longer-term study to report that Onglyza 5 mg used with insulin maintains improvement in glucose control over 24–52 weeks in adult patients with type 2 diabetes.”

In Feburary and March, respectively, FDA and the European regulatory authority approved use of a 2.5 mg dose of Onglyza by adult type II diabetics with moderate-to-severe renal impairment.