. S.A. is a member of the scientific advisory panel for and has received honoraria and/or consulting fees from Takeda/Lilly.Abbreviations: ALT, alanine aminotransferase; AST, aspartate aminotransferase; FPG, fasting plasma glucose; LOCF, last-observation-carried-forward; ULN, upper limitof normal.A table elsewhere in this issue shows conventional and Système International (SI) units and conversion factors for many substances.
Pioglitazone Hydrochloride Monotherapy Improves Glycemic Control in the Treatment of Patients With Type 2 DiabetesA 6-month randomized placebo-controlled dose-response studyOBJECTIVE -To evaluate the efficacy and safety of four doses of pioglitazone monotherapy in the treatment of patients with type 2 diabetes.RESEARCH DESIGN AND METHODS -There were 408 patients randomized in this multicenter double-blind placebo-controlled clinical trial. Patients who had HbA 1c Ն7.0%, fasting plasma glucose (FPG) Ն140 mg/dl, and C-peptide Ͼ1 ng/ml were randomized to receive placebo or 7.5, 15, 30, or 45 mg pioglitazone administered once a day for 26 weeks.RESULTS -Patients treated with 15, 30, or 45 mg pioglitazone had significant mean decreases in HbA 1c (range Ϫ1.00 to Ϫ1.60% difference from placebo) and FPG (Ϫ39.1 to Ϫ65.3 mg/dl difference from placebo). The decreases in FPG were observed as early as the second week of therapy; maximal decreases occurred after 10-14 weeks and were maintained until the end of therapy (week 26). In the 15-, 30-, or 45-mg pioglitazone groups, there were significant mean percent decreases in triglycerides, significant mean percent increases in HDL cholesterol, and only small percent changes in total cholesterol and LDL. The subset of patients naive to therapy had greater improvements in HbA 1c and FPG (difference from placebo of Ϫ2.55% and Ϫ79.9 mg/dl for the 45-mg group) compared with previously treated patients. The overall adverse event profile of pioglitazone was similar to that of placebo. There was no evidence of drug-induced hepatotoxicity or drug-induced elevations of alanine aminotransferase levels in this study.CONCLUSIONS -Pioglitazone monotherapy significantly improves HbA 1c and FPG while producing beneficial effects on serum lipids in patients with type 2 diabetes with no evidence of drug-induced hepatotoxicity.
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