October 05, 2009
Phase 3b study of Onglyza in combination with metformin for type 2 diabetesBristol-Myers Squibb and AstraZeneca announced positive results from a Phase 3b trial of Onglyza (saxagliptan tablets) in combination with metformin in adults with type 2 diabetes inadequately controlled on metformin monotherapy. This 18-week, international, multicenter, randomized, parallel-group, double-blind, active-controlled study involved 801 adults with diabetes whose baseline A1C was >6.5% and ≤10%. Positive efficacy results were achieved for the primary endpoint, which assessed if the change from baseline in A1C achieved with Onglyza was non-inferior to Januvia (sitagliptan tablets, from Merck), when both were added to a stable dose of metformin 1500mg/day or higher. Patients treated with Onglyza plus metformin achieved an adjusted mean change from baseline in A1C of –0.52%, compared to –0.62% for patients taking Januvia. The difference in adjusted mean change from baseline A1C for Onglyza plus metformin versus Januvia plus metformin was 0.09% (95% CI -0.01 to 0.2).
Onglyza is a selective, reversible inhibitor of the dipeptidyl peptidase-4 (DPP-4) enzyme already indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus.
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