Results of a randomized, double-blind, placebo-controlled study administering glimepiride to patients with type 2 diabetes mellitus inadequately controlled with rosiglitazone monotherapy.

OBJECTIVE: This study was designed to assess the efficacy and safety of glimepiride plus rosiglitazone for type 2 diabetes mellitus (DM) inadequately controlled with rosiglitazone monotherapy.

METHODS: This was a randomized, double-blind, placebo-controlled, multicenter study Patients were assigned to a 6-week forced titration of either glimepiride or placebo in combination with rosiglitazone (4 or 8 mg/d) followed by a maintenance period of 20 weeks. The outcomes were changes in glycosylated hemoglobin (HbA(1c)), fasting plasma glucose (FPG), lipid levels, and body weight, as well as safety measures.

RESULTS: Forty patients (23 women, 17 men) with type 2 DM were included in the study The mean (SD) age was 60.2 (7.8) years in the glimepiride group and 50.8 (9.7) years in the placebo group (P < 0.002). Mean (SD) screening HbA(1c) was 7.9% (0.6%) among patients receiving glimepiride and 8.4% (0.6%) among those receiving placebo. Mean (SD) duration of DM was 7.2 (8.8) and 4.6 (4.0) years, respectively Mean (SD) FPG at randomization was 155.0 (22.9) mg/dL and 180.2 (36.9) mg/dL, respectively (P < 0.018). Combination therapy with glimepiride produced greater reductions versus placebo combination in HbA(1c) (mean [SE], -12% [0.1%] vs -03% [02%]; P < 0.001) and FPG (mean [SE], -24.4 [6.0] mg/dL vs 5.9 [8.0] mg/dL; P < 0.006). More patients in the glimepiride group achieved the HbA(1c) target of < or =7% (60% vs 143%; P < 0.008). There were no significant differences in the rate or type of adverse events between groups, and no episodes of severe hypoglycemia occurred with either treatment

CONCLUSIONS: The results of this study suggest that the combination of glimepiride and rosiglitazone was efficacious and well tolerated in a small sample of patients with type 2 DM. The combination might be used to improve glycemic control in patients inadequately controlled with rosiglitazone monotherapy.