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Original Articles

Troglitazone in Combination With Sulfonylurea Restores Glycemic Control in Patients With Type 2 Diabetes

  1. Edward S Horton, MD,
  2. Fred Whitehouse, MD,
  3. Mahmoud N Ghazzi, MD, PHD,
  4. Tom C Venable, PHD,
  5. The Troglitazone Study Group† and
  6. Randall W Whitcomb, MD
  1. Joslin Diabetes Center Boston, Massachusetts
  2. Henry Ford Hospital Detroit, Michigan
  3. Parke-Davis Pharmaceutical Research, Division of Warner-Lambert Company Ann Arbor, Michigan
  1. Address correspondence and reprint requests to Dr. Mahmoud N. Ghazzi, Parke-Davis Pharmaceutical Research, Clinical Research, Diabetes and Metabolic Diseases, 2800 Plymouth Rd., Ann Arbor, MI 48105.
Diabetes Care 1998 Sep; 21(9): 1462-1469. https://doi.org/10.2337/diacare.21.9.1462
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Abstract

OBJECTIVE To determine if the combination of troglitazone (a peroxisome proliferator-activated receptor-γ activator) and sulfonylurea will provide efficacy not attainable by either medication alone.

RESEARCH DESIGN AND METHODS There were 552 patients inadequately controlled on maximum doses of sulfonylurea who participated in a 52-week randomized active-controlled multicenter study. Patients were randomized to micronized glyburide 12 mg q.d. (G12); troglitazone monotherapy 200, 400, or 600 mg q.d. (T200, T400, T600); or combined troglitazone and glyburide q.d. (T200/G12, T400/G12, T600/G12). Efficacy measures included HbA1c, fasting serum glucose (FSG), insulin, and C-peptide. Effects on lipids and safety were also assessed.

RESULTS Patients on T600/G12 had significantly lower mean (± SEM) FSG (9.3 ± 0.4 mmol/l; 167.4 ± 6.6 mg/dl) compared with control subjects (13.7 ± 0.4 mmol/l; 246.5 ± 6.8 mg/dl; P < 0.0001) and significantly lower mean HbA1c (7.79 ± 0.2 vs. 10.58 ± 0.18%, P < 0.0001). Significant dose-related decreases were also seen with T200/G12 and T400/G12. Among patients on T600/G12, 60% achieved HbA1c ≤8%, 42% achieved HbA1c ≤7%, and 40% achieved FSG ≤7.8 mmol/l (140 mg/dl). Fasting insulin and C-peptide decreased with all treatments. Overall, triglycerides and free fatty acids decreased, whereas HDL cholesterol increased. LDL cholesterol increased slightly, with no change in apolipoprotein B. Adverse events were similar across treatments. Hypoglycemia occurred in 3% of T600/G 12 patients compared with <1% on G12 or troglitazone monotherapy

CONCLUSIONS Patients with type 2 diabetes inadequately controlled on sulfonylurea can be effectively managed with a combination of troglitazone and sulfonylurea that is safe, well tolerated, and represents a new approach to achieving the glycemic targets recommended by the American Diabetes Association.

  • Received December 29, 1997.
  • Revision received June 5, 1998.
  • Accepted June 5, 1998.
  • Copyright © 1998 by the American Diabetes Association

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September 1998, 21(9)
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Troglitazone in Combination With Sulfonylurea Restores Glycemic Control in Patients With Type 2 Diabetes
Edward S Horton, Fred Whitehouse, Mahmoud N Ghazzi, Tom C Venable, The Troglitazone Study Group†, Randall W Whitcomb
Diabetes Care Sep 1998, 21 (9) 1462-1469; DOI: 10.2337/diacare.21.9.1462

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Troglitazone in Combination With Sulfonylurea Restores Glycemic Control in Patients With Type 2 Diabetes
Edward S Horton, Fred Whitehouse, Mahmoud N Ghazzi, Tom C Venable, The Troglitazone Study Group†, Randall W Whitcomb
Diabetes Care Sep 1998, 21 (9) 1462-1469; DOI: 10.2337/diacare.21.9.1462
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