Kombiglyze XR approved for treatment of type 2 diabetes mellitus (DM)
The FDA has approved Kombiglyze XR (saxagliptin and metformin extended-release tablets, from Bristol-Myers Squibb and AstraZeneca) for the treatment of type 2 diabetes in adults. This approval was based on two Phase 3 clinical trials and bioequivalence studies. The two clinical studies evaluated the efficacy and safety of saxagliptin and metformin immediate-release (IR) as separate tablets compared to placebo added to metformin IR. Bioequivalence was demonstrated in healthy adults between Kombiglyze XR and saxagliptin plus metformin XR as separate tablets.
A total of 1,306 treatment-naïve adult patients with type 2 diabetes participated in a multicenter, randomized, double-blind, active-controlled, 24-week study to evaluate the efficacy and safety of Kombiglyze XR in patients with inadequate glycemic control on diet and exercise alone. Kombiglyze XR, administered as Onglyza (saxagliptin) 5 mg and metformin IR as separate tablets (n=306; baseline HbA1c 9.4%), delivered significant reductions in HbA1c of -2.5% compared to -2.0% with metformin IR plus placebo (n=313; baseline HbA1c 9.4%).
A 24-week, randomized, double-blind, placebo-controlled study was conducted to evaluate the efficacy and safety of Kombiglyze XR in 743 adult patients with type 2 diabetes inadequately controlled on metformin monotherapy. This study showed that patients taking Kombiglyze XR, administered as Onglyza 5 mg (saxagliptin) and metformin IR as separate tablets (n=186; baseline HbA1c 8.1%), experienced significant reductions in HbA1c of -0.7% compared to an increase of +0.1% in patients taking metformin IR plus placebo (n=175; baseline HbA1c 8.1%). HbA1c reduction with Onglyza 2.5 mg plus metformin IR (n=186; baseline HbA1c 8.1%) was -0.6% versus metformin IR plus placebo.
Saxagliptin (marketed as Onglyza, from Bristol-Myers Squibb) 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. Metformin is an orally-dosed biguanidine, commonly used as a glucose lowering agent.