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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.
Ann Intern Med. 2001 May 01; 134(9 Pt 1):737-45.AIM

Abstract

BACKGROUND

The thiazolidinediones are a new class of antidiabetes medication that enhances the actions of insulin in muscle, liver, and adipose tissue. Data have been lacking on their use in combination with both sulfonylurea and metformin among patients for whom insulin is the usual therapeutic alternative for improved glycemic control.

OBJECTIVE

To determine the effects of troglitazone on hemoglobin A(1c) level in patients treated with maximum tolerated doses of sulfonylurea and metformin who have hemoglobin A(1c) levels of at least 0.085 (8.5%). This trial was completed before troglitazone was taken off the U.S. market.

DESIGN

Randomized, double-blind, placebo-controlled trial, followed by an open-label extension during which all patients received troglitazone.

SETTING

16 outpatient clinics in Canada.

PATIENTS

200 patients (mean age, 59 years) with type 2 diabetes mellitus and hemoglobin A(1c) levels at least 0.085 (8.5%) (mean hemoglobin A(1c) level, 0.097 [9.7%] and mean fasting plasma glucose level, 12.9 mmol/L [233 mg/dL]) while receiving maximum doses of sulfonylurea and metformin.

MEASUREMENTS

Levels of hemoglobin A(1c), fasting plasma glucose, total insulin, triglycerides, total cholesterol, low-density lipoprotein cholesterol, and high-density lipoprotein cholesterol.

RESULTS

Troglitazone, 400 mg/d, when added to sulfonylurea and metformin, significantly decreased hemoglobin A(1c) level by 0.014 +/- 0.002 (95% CI, 0.0167 to 0.0109; P < 0.001) (1.4% +/- 0.2% [CI, 1.67% to 1.09%]) and insulin by 19 +/- 4 pmol/L (CI, 30 to 10 pmol/L; P < 0.001). At 6 months, 43% of troglitazone-treated patients achieved hemoglobin A(1c) levels of 0.08 (8%) or lower compared with 6% of placebo recipients. Efficacy was maintained at 12 months.

CONCLUSIONS

The thiazolidinedione troglitazone, at a dosage of 400 mg/d, is effective when used in combination with sulfonylurea and metformin. Thiazolidinediones may therefore offer an effective alternative to insulin for patients treated with sulfonylurea and metformin who do not achieve adequate glycemic control.

Authors+Show Affiliations

McGill University Health Centre, 687 Pine Avenue West, Room H685, Montreal, Quebec H3A 1A1, Canada.No affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info available

Pub Type(s)

Clinical Trial
Journal Article
Multicenter Study
Randomized Controlled Trial
Research Support, Non-U.S. Gov't

Language

eng

PubMed ID

11329231

Citation

Yale, J F., et al. "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." Annals of Internal Medicine, vol. 134, no. 9 Pt 1, 2001, pp. 737-45.
Yale JF, Valiquett TR, Ghazzi MN, et al. 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. Ann Intern Med. 2001;134(9 Pt 1):737-45.
Yale, J. F., Valiquett, T. R., Ghazzi, M. N., Owens-Grillo, J. K., Whitcomb, R. W., & Foyt, H. L. (2001). 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. Annals of Internal Medicine, 134(9 Pt 1), 737-45.
Yale JF, et al. 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. Ann Intern Med. 2001 May 1;134(9 Pt 1):737-45. PubMed PMID: 11329231.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - 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. AU - Yale,J F, AU - Valiquett,T R, AU - Ghazzi,M N, AU - Owens-Grillo,J K, AU - Whitcomb,R W, AU - Foyt,H L, PY - 2001/5/1/pubmed PY - 2001/5/22/medline PY - 2001/5/1/entrez SP - 737 EP - 45 JF - Annals of internal medicine JO - Ann Intern Med VL - 134 IS - 9 Pt 1 N2 - BACKGROUND: The thiazolidinediones are a new class of antidiabetes medication that enhances the actions of insulin in muscle, liver, and adipose tissue. Data have been lacking on their use in combination with both sulfonylurea and metformin among patients for whom insulin is the usual therapeutic alternative for improved glycemic control. OBJECTIVE: To determine the effects of troglitazone on hemoglobin A(1c) level in patients treated with maximum tolerated doses of sulfonylurea and metformin who have hemoglobin A(1c) levels of at least 0.085 (8.5%). This trial was completed before troglitazone was taken off the U.S. market. DESIGN: Randomized, double-blind, placebo-controlled trial, followed by an open-label extension during which all patients received troglitazone. SETTING: 16 outpatient clinics in Canada. PATIENTS: 200 patients (mean age, 59 years) with type 2 diabetes mellitus and hemoglobin A(1c) levels at least 0.085 (8.5%) (mean hemoglobin A(1c) level, 0.097 [9.7%] and mean fasting plasma glucose level, 12.9 mmol/L [233 mg/dL]) while receiving maximum doses of sulfonylurea and metformin. MEASUREMENTS: Levels of hemoglobin A(1c), fasting plasma glucose, total insulin, triglycerides, total cholesterol, low-density lipoprotein cholesterol, and high-density lipoprotein cholesterol. RESULTS: Troglitazone, 400 mg/d, when added to sulfonylurea and metformin, significantly decreased hemoglobin A(1c) level by 0.014 +/- 0.002 (95% CI, 0.0167 to 0.0109; P < 0.001) (1.4% +/- 0.2% [CI, 1.67% to 1.09%]) and insulin by 19 +/- 4 pmol/L (CI, 30 to 10 pmol/L; P < 0.001). At 6 months, 43% of troglitazone-treated patients achieved hemoglobin A(1c) levels of 0.08 (8%) or lower compared with 6% of placebo recipients. Efficacy was maintained at 12 months. CONCLUSIONS: The thiazolidinedione troglitazone, at a dosage of 400 mg/d, is effective when used in combination with sulfonylurea and metformin. Thiazolidinediones may therefore offer an effective alternative to insulin for patients treated with sulfonylurea and metformin who do not achieve adequate glycemic control. SN - 0003-4819 UR - https://www.unboundmedicine.com/medline/citation/11329231/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_ L2 - https://www.acpjournals.org/doi/10.7326/0003-4819-134-9_part_1-200105010-00010?url_ver=Z39.88-2003&amp;rfr_id=ori:rid:crossref.org&amp;rfr_dat=cr_pub=pubmed DB - PRIME DP - Unbound Medicine ER -