Abstract:

Summary

Oral anti-diabetic combinations that address insulin resistance and -cell dysfunction (e.g. metformin and glibenclamide) represent a rational therapeutic option for patients uncontrolled on monotherapy. A 52-week, open-label extension to a double-blind study evaluated metformin-glibenclamide combination tablets (Glucovance^®) in 477 patients with hyperglycaemia despite sulphonylurea therapy. Reductions in HbA_1C were maintained, with a mean reduction of -1.7% after 52 weeks, compared with the baseline value for the double-blind trial. Eighty-five patients receiving 4 × 500 mg/2.5 mg tablets daily displayed a marked improvement in HbA_1C following up-titration to a regimen of 2 × 500 mg/2.5 mg + 3 × 500 mg/5 mg tablets. Lipid profiles improved significantly. The combination tablets were well tolerated: 11.1% of patients reported hypoglycaemic symptoms (all either mild or moderate severity). No patient withdrew or required pharmacologic intervention for hypoglycaemia. Metformin-glibenclamide combination tablets are an effective and well-tolerated therapeutic option for intensifying oral anti-diabetic therapy.

Keywords: Metformin/glibenclamide; metformin; glibenclamide; glyburide; fixed-dose combination therapy; type 2 diabetes; oral anti-diabetic therapy

Document Type: Research article

DOI: 10.1111/j.1742-1241.2004.00316.x

Affiliations: 1: New Orleans, Louisiana, Bristol-Myers Squibb Company, 2: Princeton, New Jersey, USA, Merck Santé, 3: West Drayton, UK