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.
McCluskey
Dennis
D
Dennis McCluskey and Associates, Mogadore, Ohio, USA.
Touger
M Scott
MS
Melis
Robert
R
Schleusener
Debra S
DS
McCluskey
Dennis
D
D000328:Adult; D000368:Aged; D001835:Body Weight / Q000187:drug effects; D003924:Diabetes Mellitus, Type 2 / Q000188:drug therapy*; D004311:Double-Blind Method; D004359:Drug Therapy, Combination; D005260:Female; D006801:Humans; D007004:Hypoglycemic Agents / Q000008:administration & dosage / Q000627:therapeutic use*; D008297:Male; D008875:Middle Aged; D000077154:Rosiglitazone; D013453:Sulfonylurea Compounds / Q000008:administration & dosage / Q000627:therapeutic use*; D045162:Thiazolidinediones / Q000008:administration & dosage / Q000627:therapeutic use*
D007004:Hypoglycemic Agents; D013453:Sulfonylurea Compounds; D045162:Thiazolidinediones; D000077154:Rosiglitazone; C057619:glimepiride