Glimepiride Versus Metformin as Monotherapy in Pediatric Patients With Type 2 Diabetes
A randomized, single-blind comparative study
- Michael Gottschalk, MD1,
- Thomas Danne, MD2,
- Aleksandra Vlajnic, MD3 and
- José F. Cara, MD45
- 1University of California, San Diego Medical Center, San Diego, California
- 2Kinderkrankenhaus auf der Bult, Diabetes-Zentrum für Kinder und Jugendliche, Hannover, Germany
- 3Sanofi-Aventis U.S., Bridgewater, New Jersey
- 4Children's Hospital of Michigan, Wayne State University, Detroit, Michigan
- 5Henry Ford Medical Center, Sterling Heights, Michigan
- Address correspondence and reprint requests to Michael Gottschalk, University of California, San Diego Medical Center, 3020 Childrens Way, MC 5103, San Diego, CA 92123. E-mail: mgottsch{at}ucsd.edu
Abstract
OBJECTIVE—To compare the efficacy and safety of glimepiride versus metformin in pediatric subjects with type 2 diabetes inadequately controlled with diet and exercise alone or oral monotherapy.
RESEARCH DESIGN AND METHODS—This 26-week, single-blind, active-controlled, multinational study randomized 285 subjects to receive glimepiride (1–8 mg once daily) or metformin (500–1000 mg twice daily) for 24 weeks. The primary end point was mean change in A1C from baseline to week 24. Safety was assessed by incidence of hypoglycemia and other adverse events.
RESULTS—Significant reductions from baseline A1C were seen in both the glimepiride (−0.54%, P = 0.001) and metformin (−0.71%, P = 0.0002) groups. A total of 42.4% (56 of 132) and 48.1% (63 of 131) of subjects in the glimepiride and metformin groups, respectively, in the intent-to-treat population achieved A1C <7.0% at week 24. No significant differences were observed between groups in reductions in A1C and self-monitored blood glucose levels, changes in serum lipid concentrations, or hypoglycemia incidence. Significant differences were observed in mean changes from baseline in BMI between groups (0.26 kg/m2 for glimepiride and −0.33 kg/m2 for metformin; P = 0.003). The adjusted mean body weight increase was 1.97 kg for glimepiride and 0.55 kg for metformin (P = 0.005). A hypoglycemic episode with blood glucose <50 mg/dl (<2.8 mmol/l) was experienced by 4.9 and 4.2% of glimepiride- and metformin-treated subjects, respectively. A single severe hypoglycemic event occurred in each group.
CONCLUSIONS—Glimepiride reduced A1C similarly to metformin with greater weight gain, and there was comparable safety over 24 weeks in the treatment of pediatric subjects with type 2 diabetes.
Footnotes
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A.V. currently is affiliated with Sanofi-Aventis U.S. J.F.C. currently is affiliated with Pfizer Global Pharmaceuticals. T.D. has received honoraria, consulting fees, and grant support from Abbott MediSense, Sanofi-Aventis, Bayer, Roche, Lifescan, Lilly, Medtronic Minimed, Menarini, Novo Nordisk, and Pharmacia.
A table elsewhere in this issue shows conventional and Système International (SI) units and conversion factors for many substances.
DOI: 10.2337/dc06-1554. Clinical trial reg. no. NCT00353691, www.clinicaltrials.gov.
The costs of publication of this article were defrayed in part by the payment of page charges. This article must therefore be hereby marked “advertisement” in accordance with 18 U.S.C Section 1734 solely to indicate this fact.
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- Accepted December 27, 2006.
- Received July 24, 2006.
- DIABETES CARE
