Phase 2b results have demonstrated that an investigational, once-weekly DPP-IV inhibitor significantly lowered HbA1c, compared with placebo, among patients with type 2 diabetes. The drug was also well-tolerated with a safety profile similar to that of placebo, according to a press release issued from the 48th European Association for the Study of Diabetes Annual Meeting in Berlin.
The drug, MK-3102 (Merck), was administered at five doses (0.25 mg, 1 mg, 3 mg, 10 mg and 25 mg) to patients with type 2 diabetes with inadequate glycemic control on diet and exercise.
Patients with a mean baseline HbA1c of 8% (n=685) were randomly assigned to MK-3102 at one of five once-weekly doses (0.25 mg, n=113; 1 mg, n=115; 3 mg, n=114; 10 mg, n=115; 25 mg, n=114) or placebo (n=114) for 12 weeks. According to the press release, the primary endpoint was change in HbA1c from baseline at the trial’s end across all doses. Secondary endpoints included 2-hour post-meal glucose and fasting plasma glucose (FPG).
Patients assigned to MK-3102 at all doses had a significantly lower HbA1c compared with those assigned to placebo (P<.001). At 12 weeks, placebo-adjusted reduction in HbA1c from baseline was 0.71% in the 25-mg group, 0.67% in the 10-mg group, 0.49% in the 3-mg group, 0.50% in the 1-mg group and 0.28% in the 0.25-mg group.
Among secondary endpoints, a statistically significant (P<.001) trend was observed across all doses for both 2-hour post-meal glucose and FPG. Placebo-adjusted reductions in HbA1c from baseline to 12 weeks for 2-hour post-meal glucose were 2.5 mmol/L for 25 mg; 2.3 mmol/L for 10 mg; 1.9 mmol/L for 3 mg; 1.9 mmol/L for 1 mg; and 1.0 mmol/L for 0.25 mg. Reductions for FPG were 1.2 mmol/L for 25 mg; 0.7 mmol/L for 10 mg; 0.8 mmol/L for 3 mg; 1.1 mmol/L for 1 mg; and 0.1 mmol/L for 0.25 mg.
According to the press release, the study drug was generally well-tolerated, with a safety profile similar to that of placebo.
For more information:
Gantz I. #110. Presented at: the European Association for the Study of Diabetes 48th Annual Meeting; October 1-5, 2012; Berlin.