Triple therapy with glimepiride in patients with type 2 diabetes mellitus inadequately controlled by metformin and a thiazolidinedione: results of a 30-week, randomized, double-blind, placebo-controlled, parallel-group study

摘要: Abstract Objective: This study evaluated the efficacy and1026 tolerability of glimepiride in patients with type 2 diabetes mellitus that was inadequately controlled a combination immediate- or extended-release metformin and thiazolidinedione. Methods: multicenter, randomized, double-blind,1026 placebo-controlled, parallel-group, 2-arm consisting 4-week stabilization eligibility period 26-week treatment period. Patients diagnosis for minimum 1 year received (titrated sequentially from to 4 8 mg/d over 6 weeks, followed by 20 weeks maintenance therapy) placebo an established regimen extended release rosiglitazone pioglitazone. The primary outcome change glycosylated hemoglobin (HbA 1c ) baseline. safety analysis based on incidence hypo glycemia, adverse events, laboratory abnormalities. Changes lipid levels (high-density lipoprotein cholesterol, total low-density very low density triglycerides) were evaluated, health-related quality life assessed scores Diabetes Care Profile (DCP) Health Utilities Index Mark 3 (HU13). Results: Of 170 randomized patients, 159 included1026 168 included analysis. Demographic variables similar at baseline between groups (mean age, 56.5 56.4 years, respectively; percent men/women, 61.0%/39.0% 62.3%/37.7%; weight, 100.9 96.3 kg). HbA significantly improved end point therapy compared [SE], −1.31% [0.08] vs −0.33% [0.08], P value ≤7%, 26.0% receiving ( 0.17 (0.16) kg/m Conclusions: In these 1026 not adequately dual thiazolidinedione, addition glycemic control acceptable profile. Although there more episodes hypoglycemia triple than placebo, risk severe low.