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The Effect of a Thiazolidinedione Drug, Troglitazone, on Glycemia in Patients with Type 2 Diabetes Mellitus Poorly Controlled with Sulfonylurea and Metformin: A Multicenter, Randomized, Double-Blind, Placebo-Controlled Trial

Jean-François Yale, MD; Thomas R. Valiquett, MS; Mahmoud N. Ghazzi, MD, PhD; Janet K. Owens-Grillo, PhD; Randall W. Whitcomb, MD; Howard L. Foyt, MD, PhD, Troglitazone Triple-Therapy Study Group*
[+] Article and Author Information

From McGill University, Montreal, Quebec, Canada; and Parke-Davis Pharmaceutical Research, Ann Arbor, Michigan.


Note: Portions of these data were present at the 59th Annual Meeting of the American Diabetes Association, June 1999.

Acknowledgments: The authors thank Miggi Tomovici, Nadia Romano, Daniel Strieter, Sandra Vermeulen, and Barbara Faja for their assistance with summarizing data.

Grant Support: By Parke-Davis Pharmaceutical Research Division of Warner-Lambert Company.

Requests for Single Reprints: Jean-François Yale, MD, McGill University Health Centre, 687 Pine Avenue West, Room H685, Montreal, Quebec H3A 1A1, Canada.

Current Author Addresses: Dr. Yale: McGill University Health Centre, 687 Pine Avenue West, Room H685, Montreal, Quebec H3A 1A1, Canada.

Mr. Valiquett and Drs. Ghazzi, Owens-Grillo, Whitcomb, and Foyt: Pfizer Global Research and Development, 2800 Plymouth Road, Ann Arbor, MI 48105.

Author Contributions: Conception and design: J.F. Yale, T.R. Valiquett, M.N. Ghazzi, R.W. Whitcomb, H.L. Foyt.

Analysis and interpretation of the data: J.F. Yale, T.R. Valiquett, J.K. Owens-Grillo, R.W. Whitcomb, H.L. Foyt.

Drafting of the article: J.F. Yale, T.R. Valiquett.

Critical revision of the article for important intellectual content: T.R. Valiquett, J.K. Owens-Grillo, R.W. Whitcomb, H.L. Foyt.

Final approval of the article: J.F. Yale, R.W. Whitcomb, H.L. Foyt.

Provision of study materials or patients: J.F. Yale.

Administrative, technical, or logistic support: J.K. Owens-Grillo.

Collection and assembly of data: T.R. Valiquett, J.K. Owens-Grillo.


Ann Intern Med. 2001;134(9_Part_1):737-745. doi:10.7326/0003-4819-134-9_Part_1-200105010-00010
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Persistent hyperglycemia secondary to insulin resistance and eventual insufficient insulin secretory capacity is the hallmark of type 2 diabetes mellitus. Resistance to insulin-stimulated glucose uptake is present in most patients with this disease (1). Treatment is aimed at reducing blood glucose levels to normal or near-normal values (23). Diet and exercise are the first treatments of choice for patients with type 2 diabetes mellitus. However, as many as 95% of those with newly diagnosed diabetes do not achieve adequate blood glucose control after a 3-month dietary intervention (4), and initiation with oral antidiabetes therapy is then advocated.

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Figures

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Figure 1. ALT = alanine aminotransferase.
Random assignment and disposition of patients.
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Figure 2. The troglitazone/troglitazone group ( ) was treated with troglitazone, 400 mg/d, for the entire 48 weeks; the placebo/troglitazone group ( ) was treated with a placebo for the first 24 weeks and with troglitazone, 400 mg/d, for the last 24 weeks. Data are presented as the mean ± SE. Change in fasting glucose level from baseline to 24 weeks (double-blind period) and from 24 to 48 weeks (open-label period). To convert glucose values in mmol/L to mg/dL, multiply by 18.0. Change in hemoglobin A level over time. To convert hemoglobin values to percentages, multiply by 100.
Changes in fasting glucose and hemoglobin A 1c levels from baseline to 6 and 12 months.dotted linessolid linesTop.Bottom.1c
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Summary for Patients

Triple-Drug Therapy May Improve Sugar Control in Adults with Diabetes

The summary below is from the full report titled “The Effect of a Thiazolidinedione Drug, Troglitazone, on Glycemia in Patients with Type 2 Diabetes Mellitus Poorly Controlled with Sulfonylurea and Metformin. A Multicenter, Randomized, Double-Blind, Placebo-Controlled Trial.” It is in the 1 May 2001 issue of Annals of Internal Medicine (volume 134, pages 737-745). The authors are JF Yale, TR Valiquett, MN Ghazzi, JK Owens-Grillo, RW Whitcomb, and HL Foyt, for the Troglitazone Triple-Therapy Study Group.

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