MK-0941 Safe, Efficacious for Short-Term Glucose Control

Improvements in A1C, two-hour postmeal glucose seen at week 14 were not sustained by week 30

THURSDAY, Dec. 1 (HealthDay News) -- For patients taking stable-dose insulin glargine, use of a glucokinase inhibitor (GKA), MK-0941, leads to significant improvement in glycemic control at week 14, which is not sustained by 30 weeks, according to a study published in the December issue of Diabetes Care.

Gary E. Meininger, M.D., from the Merck Sharp & Dhome Corporation in Rahway, N.J., and colleagues evaluated the safety and efficacy of MK-0941 in 587 patients with type 2 diabetes taking stable-dose insulin glargine (with or without metformin). The participants were randomized to receive 10, 20, 30, or 40 mg of MK-0941 or matching placebo three times a day before meals. After the initial dose-ranging phase of 14 weeks, Mk-0941 was uptitrated in participants, as tolerated, to 40 mg MK-0941 or placebo, during a 40-week treatment phase. The change in hemoglobin A1C from baseline to week 14 was the primary efficacy end point.

The investigators identified significant improvements in A1C and two-hour postmeal glucose (PMG) with all MK-0941 doses, compared to placebo, at week 14. The A1C and two-hour PMG showed maximal placebo-adjusted least squares mean changes from baseline of −0.8 percent and −37 mg/dl, respectively. Compared to placebo, no MK-0941 dose showed significant effects on fasting plasma glucose. The initial glycemic responses observed at 14 weeks were not sustained by 30 weeks. One or more MK-0941 doses correlated with significant increases in the incidence of hypoglycemia, triglycerides, systolic blood pressure, and the proportion of patients with increased diastolic blood pressure who met predefined limits of change.

"The GKA MK-0941 led to improvements in glycemic control that were not sustained," the authors write.

Several of the study authors disclosed financial ties with pharmaceutical companies, including Merck Sharp & Dhome Corporation, which funded the study and manufactures MK-0941.

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