ONGLYZA® (saxagliptin)

How do you choose the right DPP-4 inhibitor for your patients with type 2 diabetes?

Study details: De Fronzo et al. 2009

This was a 24-week, randomised, double-blind, placebo-controlled study of saxagliptin (2.5, 5, or 10 mg once daily) or placebo plus a stable dose of metformin (1500 —2500 mg) in 743 patients (HbA1c ≥ 7.0 and ≤ 10.0%). The aim of the trial was to assess the efficacy and safety of saxagliptin as add-on therapy in patients with type 2 diabetes with inadequate glycaemic control with metformin alone.

Of the 1,462 patients screened, 743 were randomly assigned and received study treatment and 73% (543 of 743) completed 24 weeks of treatment.

Patients completing the 24-week treatment period or those who met the rescue criteria could enter the 42-month long-term extension.
The primary efficacy outcome was change from baseline in A1C to week 24. Secondary end-points included change from baseline to week 24 in fasting plasma glucose (FPG), the percentage of patients at the glycaemic target (defined as A1C <7.0%), and postprandial glucose (PPG) 3-h area under the curve (AUC) during a 75-g oral glucose tolerance test (OGTT).