Diamicron®MR once daily is effective and well tolerated in type 2 diabetes -: A double-blind, randomized, multinational study

In a double-blind, multicenter, multinational study, the long-term efficacy and safety of Diamicron(R)MR, a new gliclazide formulation taken once daily at lower dose (30-120 mg/day) was compared with Diamicron(R) (80-320 mg/day) taken twice daily in type 2 diabetic outpatients. After a 2-week run-in period, 800 patients with poor blood glucose control were randomized to Diamicron(R)MR (n=401) or Diamicron(R) (n=399). After a 4-month titration period, the efficacy and safety of Diamicron(R)MR was compared with Diamicron(R) over a 6-month fixed-dose treatment period. The ability to switch from Diamicron(R) to Diamicron(R)MR was then assessed during an additional 2-month follow-up period. Equivalence between treatment with Diamicron(R)MR and Diamicron(R) was compared by a non-inferiority test; the limit of equivalence was set at 0.5% for HbA(1c) and 1 mmol/l for fasting plasma glucose (FPG). The treatment groups were comparable at baseline. After 10 months of treatment, Diamicron(R)MR was as efficient as Diamicron(R) in controlling blood glucose, with a mean end point difference in HbA(1c) of - 0.08 (0.08)%, significantly lower than the equivalence limit (p<0.001). Similar results were obtained for FPG. The safety of Diamicron(R)MR and Diamicron(R) was equally high. The incidence of hypoglycemia was particularly low (0.2 hypoglycemia/100 patient months) in the elderly population, which represented almost 40% of the included patients. This study demonstrates that 30 to 120 mg of Diamicron(R)MR taken once daily is at least as efficient as 80 to 320 mg of Diamicron(R) taken in divided doses with respect to HbA(1c) and FPG levels, with a similar safety profile. (C) 2000 Elsevier Science Inc. All rights reserved.