Simultaneous glyburide/metformin therapy is superior to component monotherapy as an initial pharmacological treatment for type 2 diabetes

doi:10.1046/j.1463-1326.2002.00211.x

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Wiley InterScience

Diabetes, Obesity and Metabolism

Volume 4 Issue 3, Pages 201 - 208

Published Online: 30 May 2002

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Simultaneous glyburide/metformin therapy is superior to component monotherapy as an initial pharmacological treatment for type 2 diabetes

A. J. Garber ¹ , J. Larsen ² , S. H. Schneider ³ , B. A. Piper ⁴ and D. Henry ⁴ on behalf of The Glyburide/Metformin Initial Therapy Study Group

¹ Baylor College of Medicine and The Methodist Hospital, Houston, Texas, USA ² University of Nebraska Medical Center-DEM, Omaha, Nebraska, USA ³ Robert Wood Johnson University Hospital, New Brunswick, New Jersey, USA ⁴ Bristol-Myers Squibb Pharmaceutical Research Institute, Princeton, New Jersey, USA

Correspondence: Dr A. J. Garber, Baylor College of Medicine and, The Methodist Hospital, 6550 Fannin, Suite 1045, Houston, TX 77030, USA.E-mail:agarber@bcm.tmc.edu

KEYWORDS

type 2 diabetes • glyburide • metformin • glycaemic control • combination glyburide • metformin therapy/glibenclamide

Objective:

Objective:To evaluate whether simultaneous initial treatment of both insulin resistance and impaired β-cell insulin secretion with glyburide/metformin tablets is superior to monotherapy with each component agent.

Research Design and Methods:

Research Design and Methods:In this randomized, parallel-group, placebo-controlled, multicentre study, 806 patients with type 2 diabetes (mean duration, 3 years) who had failed diet and exercise were randomly assigned to 4 weeks of therapy with placebo, glyburide 2.5 mg, metformin 500 mg, glyburide/metformin 1.25/250 mg, or glyburide/metformin 2.5/500 mg once daily. Doses were then titrated over 8 weeks based on glycaemic response. The primary outcome measure was change from baseline in mean HbA_1c after 20 weeks. Changes in fasting plasma glucose, lipids and body weight were also assessed along with 2-h postprandial glucose and insulin values after a standardized meal.

Results:

Results:At week 20, patients taking glyburide/metformin 1.25/250 mg or 2.5/500 mg tablets had greater reductions in HbA_1c levels (−1.48% and −1.53% respectively) compared with placebo (−0.21%; both p < 0.001), glyburide (−1.24%; p = 0.016 and p = 0.004 respectively) or metformin (−1.03%; both p < 0.001). Fasting plasma glucose concentrations were reduced more in both glyburide/metformin groups compared with placebo and metformin (p < 0.001); patients in both combination therapy groups also had significantly lower postprandial glucose concentrations compared with placebo, glyburide and metformin.

Conclusions:

Conclusions:Initial combination treatment with glyburide/metformin tablets produces greater improvements in glycaemic control than either glyburide or metformin monotherapy. The superiority of initial therapy with glyburide/metformin tablets may arise from simultaneous treatment of both pathophysiological defects of type 2 diabetes.

Received 28 September 2001; returned for revision 30 October 2001; revised version accepted 8 January 2002

DIGITAL OBJECT IDENTIFIER (DOI)

10.1046/j.1463-1326.2002.00211.x About DOI