Comparison of fixed-dose rosiglitazone/metformin combination therapy with sulphonylurea plus metformin in overweight individuals with Type 2 diabetes inadequately controlled on metformin alone.

摘要: AIM This 52-week, randomized, double-blind, parallel-group study was designed to compare rosiglitazone/metformin fixed-dose combination therapy with sulphonylurea plus metformin in overweight individuals inadequately controlled type 2 diabetes mellitus. METHOD Individuals inadequate glycaemic control (HbA (1c)> or =7%) while on monotherapy (> =0.85 g/day) entered a 4-week run-in period during which they received g/day. At the end of run-in, fasting plasma glucose > =7.0 mmol/l were randomized treatment (2 and either rosiglitazone (4 mg/day; RSG+MET [N=294]) (glibenclamide 5 mg/day gliclazide 80 SU+MET [N=302]). Medications up-titrated maximum tolerated doses (rosiglitazone 8 mg, glibenclamide 15 mg 320 first 12 weeks double-blind treatment. The primary efficacy point change HbA (1c) from baseline after 52 RESULTS non-inferior respect changes one year (DeltaHbA (1c)= -0.78% -0.86%, respectively; difference =0.09%, 95% CI=-0.08, 0.25). reductions RSG+MET, but not SU+MET, accompanied by significant improvements measures beta-cell function including proinsulin:insulin ratio. degree failure significantly greater compared as measured coefficient (0.543 vs. 0.055 (1c)%/year, respectively, p=0.0002). proportion who experienced hypoglycaemic events (p<0.0001) lower (6%) than (30%). Diastolic ambulatory blood pressure cardiovascular biomarkers (high-sensitivity C-reactive protein plasminogen activator inhibitor-1) also reduced following SU+MET. Both treatments generally well tolerated. CONCLUSION Fixed-dose is reducing over Improvements suggest that may be better maintained long-term combination.