Porównanie monoterapii repaglinidem i nateglinidem. Wieloośrodkowe badanie randomizowane

INTRODUCTION. A randomized, parallel-group, openlabel, 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. MATERIAL 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 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 baseline HbA 1c 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 HbA 1c 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 1c values 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.