One-Year Glycemic Control With a Sulfonylurea Plus Pioglitazone Versus a Sulfonylurea Plus Metformin in Patients With Type 2 Diabetes

  1. Markolf Hanefeld, MD, PHD1,
  2. Paolo Brunetti, MD2,
  3. Guntram H. Schernthaner, MD3,
  4. David R. Matthews, FRCP, MA4,
  5. Bernard H. Charbonnel, MD5 and
  6. on behalf of the QUARTET Study Group
  1. 1Centre for Clinical Studies, GWT Technical University, Dresden, Germany
  2. 2Department of Internal Medicine and Metabolic Diseases, University of Perugia, Via Enrico Dal Pozzo, Perugia, Italy
  3. 3Department of Medicine 1, Division of Hematology and Hemostaseology, Rudolfstiftung Hospital, Vienna, Austria
  4. 4Oxford Centre for Diabetes, Endocrinology and Metabolism, Radcliffe Infirmary, Oxford, U.K.
  5. 5Clinique d’Endocrinologie, Hôtel Dieu, Nantes cedex, France
  1. Address correspondence and reprint requests to Professor M. Hanefeld, Centre for Clinical Studies, GWT Technical University, Dresden, Germany. E-mail: hanefeld{at}gwt-tud.de

Abstract

OBJECTIVE—The goal was to assess the 1-year efficacy and safety of the addition of pioglitazone or metformin to existing sulfonylurea (SU) therapy in patients with inadequately controlled type 2 diabetes.

RESEARCH DESIGN AND METHODS—In this multicenter, double-blind study, patients were randomized to receive either pioglitazone 15 mg (n = 319) or metformin 850 mg (n = 320) and up to 45 mg/day and 2,550 mg/day, respectively. The primary efficacy endpoint was HbA1c at week 52. Fasting plasma glucose, insulin, and lipid profiles were also measured.

RESULTS—HbA1c was reduced by 1.20% in the SU plus pioglitazone group and 1.36% in the SU plus metformin group, and fasting plasma glucose was reduced by 2.2 and 2.3 mmol/l in the respective groups. Fasting insulin levels were also reduced (pioglitazone arm −1.3 μIU/ml; metformin arm −0.8 μIU/ml). There were no significant between-treatment differences in these three parameters. Pioglitazone addition to SU significantly reduced triglycerides (−16 vs. −9%; P = 0.008) and increased HDL cholesterol (14 vs. 8%; P < 0.001) compared with metformin addition. LDL cholesterol was increased 2% by the addition of pioglitazone and decreased 5% by the addition of metformin to SU (P < 0.001). Urinary albumin-to-creatinine ratio was reduced by 15% in the SU plus pioglitazone group and increased 2% in the SU plus metformin group (P = 0.017). Both combinations were well tolerated with no evidence of hepatic or cardiac toxicity in either group.

CONCLUSIONS—Clinically equivalent improvements in glycemic control were observed for both combinations. Compared with metformin plus SU, addition of pioglitazone to SU resulted in a reduction of the urinary albumin-to-creatinine ratio, a small but significant rise in LDL cholesterol, and significantly greater improvements in triglyceride levels and HDL cholesterol levels. Metformin plus SU was associated with a significant reduction in LDL cholesterol. SU plus pioglitazone is an effective and well-tolerated combination regimen that may provide additional beneficial effects for patients with type 2 diabetes.

Footnotes

  • M.H. has received honoraria/consulting fees for lectures/consultations from Bayer AG, GlaxoSmithKline, AstraZeneca, MSD SHARP & DOHME, Takeda Pharmaceuticals, Aventis, Sanofi, and local health care organizations in Germany. P.B. has received honoraria for lectures from Eli Lilly, Novo Nordisk, and Takeda Pharmaceuticals. G.H.S. is on the board of directors for Aventis, Servier, AstraZeneca, and Merck and has received honoraria for speaking engagements from Aventis, Takeda Pharmaceuticals, GlaxoSmithKline, Merck, Servier, Novo Nordisk, Eli Lilly, and Bayer AG. D.R.M. has received honoraria/consulting fees for lectures from and participates in scientific advisory boards for Novo Nordisk, Novo Nordisk U.K., GlaxoSmithKline, and Takeda Pharmaceuticals and has received research support from Takeda U.K. and Pfizer. B.H.C. has received honoraria for speaking engagements from and is a paid consultant for Takeda Pharmaceuticals.

    A table elsewhere in this issue shows conventional and Système International (SI) units and conversion factors for many substances.

    • Accepted September 23, 2003.
    • Received May 21, 2003.
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  1. doi: 10.2337/diacare.27.1.141 Diabetes Care January 2004 vol. 27 no. 1 141-147
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