Repaglinide Versus Nateglinide Monotherapy

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  • FGfor the Repaglinide Versus Nateglinide Comparison Study Group
    for the Repaglinide Versus Nateglinide Comparison Study Group
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Abstract
OBJECTIVE—A randomized, parallel-group, open-label, multicenter 16-week clinical trial compared efficacy and safety of repaglinide monotherapy and nateglinide monotherapy in type 2 diabetic patients previously treated with diet and exercise. RESEARCH DESIGN AND METHODS—Enrolled patients (n = 150) had received treatment with diet and exercise in the previous 3 months with HbA1c >7 and ≤12%. Patients were randomized to receive monotherapy with repaglinide (n = 76) (0.5 mg/meal, maximum dose 4 mg/meal) or nateglinide (n = 74) (60 mg/meal, maximum dose 120 mg/meal) for 16 weeks. Primary and secondary efficacy end points were changes in HbA1c and fasting plasma glucose (FPG) values from baseline, respectively. Postprandial glucose, insulin, and glucagon were assessed after a liquid test meal (baseline, week 16). Safety was assessed by incidence of adverse events or hypoglycemia. RESULTS—Mean baseline HbA1c values were similar in both groups (8.9%). Final HbA1c values were lower for repaglinide monotherapy than nateglinide monotherapy (7.3 vs. 7.9%). Mean final reductions of HbA1c were significantly greater for repaglinide monotherapy than nateglinide monotherapy (−1.57 vs. −1.04%; P = 0.002). Mean changes in FPG also demonstrated significantly greater efficacy for repaglinide than nateglinide (−57 vs. −18 mg/dl; P < 0.001). HbA1c values 1c and FPG values after 16 weeks of therapy.

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