A randomized, double-blind, placebo-controlled, clinical trial of the effects of pioglitazone on glycemic control and dyslipidemia in oral antihyperglycemic medication-naive patients with type 2 diabetes mellitus

• Published in: Clinical therapeutics 2003-04, Vol.25 (4), p.1074-1095
• Main Authors: Herz, Matthias, Johns, Don, Reviriego, Jesus, Grossman, Loren D, Godin, Chantal, Duran, Santiago, Hawkins, Federico, Lochnan, Heather, Escobar-Jiménez, Fernando, Hardin, Philip A, Konkoy, Christopher S, Tan, Meng H
• Format: Article
• Language: English
• Subjects: Adult; Aged; Aged, 80 and over; Apolipoproteins; Biological and medical sciences; Blood Glucose - metabolism; Cardiovascular disease; Coronary vessels; Diabetes; Diabetes Mellitus, Type 2 - complications; Diabetes Mellitus, Type 2 - drug therapy; Diabetes Mellitus, Type 2 - metabolism; Dose-Response Relationship, Drug; Double-Blind Method; Female; General and cellular metabolism. Vitamins; Glucose; Glycated Hemoglobin A - metabolism; Heart; Homeostasis; Hospitals; Humans; hyperglycemia; Hyperlipidemias - blood; Hyperlipidemias - complications; Hypoglycemic Agents - administration & dosage; Hypoglycemic Agents - adverse effects; Hypoglycemic Agents - therapeutic use; Insulin - blood; Insulin resistance; Lipids - blood; lipoprotein; Lipoproteins; Liver diseases; Male; Medical sciences; Metabolic disorders; Middle Aged; monotherapy; Mortality; Particle size; Pharmacology. Drug treatments; pioglitazone; Plasma; Risk factors; Thiazoles - administration & dosage; Thiazoles - adverse effects; Thiazoles - therapeutic use; Thiazolidinediones; Treatment Outcome; type 2 diabetes mellitus; Vein & artery diseases; Weight control
• ISSN: 0149-2918; 1879-114X
• DOI: 10.1016/S0149-2918(03)80068-1

Objective: The goal of this study was to compare the effects of 2 doses of pioglitazone hydrochloride (a thiazolidinedione insulin sensitizer) with placebo on glycated hemoglobin (HbA1c), insulin sensitivity, and lipid profiles in patients with type 2 diabetes mellitus who had suboptimal glycemic control and mild dyslipidemia. Methods: Patients with type 2 diabetes mellitus (HbA1c ≥6.5% and ≤9.8%) who had not previously received insulin or oral antihyperglycemic medications (OAMs) were randomized to treatment with placebo, pioglitazone 30 mg QD, or pioglitazone 45 mg QD in double-blind fashion for 16 weeks at 41 centers in Canada and Spain. Results: A total of 297 patients were randomized (99 in each group). Overall, 286 (96.3%) were white. Mean (SD) age was 58.4 (10.9) years (range, 24–85 years), mean (SD) body mass index was 31.4 (4.8) kg/m2, mean (SD) duration of type 2 diabetes mellitus was 20.0 (37.4) months, and 30.6% of patients were receiving medication for dyslipidemia. Treatment with pioglitazone 30 or 45 mg QD for 16 weeks reduced mean HbA1c by 0.8% and 0.9% from baseline, respectively (both P < 0.001 vs baseline and placebo). A reduction in HbA1c of 0.2% was observed in the placebo group (P = 0.025). In patients with medium (≥7% to