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 ϭ 150) had received treatment with diet and exercise in the previous 3 months with HbA 1c Ͼ7 and Յ12%. Patients were randomized to receive monotherapy with repaglinide (n ϭ 76) (0.5 mg/meal, maximum dose 4 mg/meal) or nateglinide (n ϭ 74) (60 mg/meal, maximum dose 120 mg/meal) for 16 weeks. Primary and secondary efficacy end points were changes in HbA 1c 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 baselineHbA 1c values were similar in both groups (8.9%). Final HbA 1c values were lower for repaglinide monotherapy than nateglinide monotherapy (7.3 vs. 7.9%). Mean final reductions of HbA 1c were significantly greater for repaglinide monotherapy than nateglinide monotherapy (Ϫ1.57 vs. Ϫ1.04%; P ϭ 0.002). Mean changes in FPG also demonstrated significantly greater efficacy for repaglinide than nateglinide (Ϫ57 vs. Ϫ18 mg/dl; P Ͻ 0.001). HbA 1c values Ͻ7% were achieved by 54% of repaglinide-treated patients versus 42% for nateglinide. Median final doses were 6.0 mg/day for repaglinide and 360 mg/day for nateglinide. There were 7% of subjects treated with repaglinide (five subjects with one episode each) who had minor hypoglycemic episodes (blood glucose Ͻ50 mg/dl) versus 0 patients for nateglinide. Mean weight gain at the end of the study was 1.8 kg in the repaglinide group as compared with 0.7 kg for the nateglinide group.CONCLUSIONS -In patients previously treated with diet and exercise, repaglinide and nateglinide had similar postprandial glycemic effects, but repaglinide monotherapy was significantly more effective than nateglinide monotherapy in reducing HbA 1c and FPG values after 16 weeks of therapy.
Diabetes Care 27:1265-1270, 2004R epaglinide (Prandin) and nateglinide (Starlix) are short-acting insulin secretagogues that are approved for the treatment of type 2 diabetes (1,2). Both of these agents have relatively short elimination half-lives (1 h for repaglinide and 1.5 h for nateglinide). When administered at mealtimes, both agents produce peak insulin stimulation during the postprandial period, when physiological insulin needs are maximal. Clinical trials have demonstrated that both agents increase insulin response to postprandial glucose, resulting in reductions of HbA 1c and fasting plasma glucose (FPG) levels.Although both repaglinide and nateglinide stimulate insulin secretion by inhibition of the ATP-dependent potassium channels of -cells, the molecular binding site of repaglinide is different from that of nateglinide and sulfonylureas (3-5). Clinical trial comparisons of repaglinide versus sulfonylurea mono...
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