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Metformin‐glibenclamide versus metformin plus rosiglitazone in patients with type 2 diabetes inadequately controlled on metformin monotherapy
Author(s) -
Garber A.,
Klein E.,
Bruce S.,
Sankoh S.,
Mohideen P.
Publication year - 2006
Publication title -
diabetes, obesity and metabolism
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 2.445
H-Index - 128
eISSN - 1463-1326
pISSN - 1462-8902
DOI - 10.1111/j.1463-1326.2005.00570.x
Subject(s) - metformin , glibenclamide , medicine , rosiglitazone , type 2 diabetes , diabetes mellitus , endocrinology , pharmacology
Aim: This double‐blind study evaluated the efficacy and safety of metformin‐glibenclamide tablets vs. metformin plus rosiglitazone therapy in patients with type 2 diabetes inadequately controlled on metformin monotherapy. Subjects and methods: After an open‐label, metformin lead‐in phase, 318 patients were randomly assigned to treatment based on metformin‐glibenclamide 500/2.5 mg tablets (initial daily dose 1000/5 mg) or metformin 500 mg plus rosiglitazone 4 mg (initial daily dose 1000–2000 mg + 4 mg, depending on previous treatment) for 24 weeks. Doses were titrated to achieve the therapeutic glycaemic target. The primary efficacy variable was the change in HbA 1C . Results: At week 24, metformin‐glibenclamide tablets resulted in significantly greater reductions in HbA 1C (−1.5%) and fasting plasma glucose [−2.6 mmol/l (−46 mg/dl)] than metformin plus rosiglitazone [−1.1%, p < 0.001; −2 mmol/l (−36 mg/dl), p = 0.03]. More patients receiving metformin‐glibenclamide attained HbA 1C <7.0% than did those in the metformin plus rosiglitazone group (60 vs. 47%) and had fasting plasma glucose levels <7 mmol/l (<126 mg/dl) by week 24 (34 vs. 25%). Both treatments were well tolerated. Frequency of adverse gastrointestinal events was comparable between groups. Four per cent of patients receiving metformin‐glibenclamide withdrew because of symptomatic hypoglycaemia contrasted with 3% of patients receiving metformin plus rosiglitazone who withdrew because of persistent hyperglycaemia. Hypoglycaemic events were mild or moderate in intensity and were easily self‐managed. Conclusions: Metformin‐glibenclamide tablets resulted in significantly greater reductions in HbA 1C and fasting plasma glucose compared with metformin plus rosiglitazone in patients with type 2 diabetes inadequately controlled on metformin monotherapy.