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- Title
A randomized-controlled trial to investigate the effects of rivoglitazone, a novel PPAR gamma agonist on glucose-lipid control in type 2 diabetes.
- Authors
Kong, A. P. S.; Yamasaki, A.; Ozaki, R.; Saito, H.; Asami, T.; Ohwada, S.; Ko, G. T. C.; Wong, C. K.; Leung, G. T. C.; Lee, K. F.; Yeung, C. Y.; Chan, J. C. N.
- Abstract
Aim: To examine the efficacy, safety and tolerability of rivoglitazone, a novel thiazolidinedione (TZD), and explore its effects on glucose and lipid control compared to placebo and pioglitazone in Chinese type 2 diabetic patients who are treatment naÏve or treated with a single oral blood glucose-lowering drug. Methods: This was a double-blind, randomized, placebo- and active-controlled study. A total of 287 Chinese type 2 diabetic patients with suboptimal glycaemic control (defined as HbA1c ≥6.5 to <10% and fasting plasma glucose ≥7 to ≤15 mmol/l) were enrolled. One hundred and seventy-four eligible patients were randomized into one of the five treatment arms for 12 weeks: placebo, pioglitazone 30 mg daily, rivoglitazone of dose 0.5, 1.0 or 1.5 mg daily. In a full set analysis, we used analysis of covariance to compare the primary endpoint defined as change in HbA1c from baseline to week 12/last observation carried forward in the rivoglitazone group at each dose level with the placebo group. Results: Changes in HbA1c were −0.11% in the 0.5-mg group; −0.22% in the 1-mg group and −0.17% in the 1.5-mg rivoglitazone group; −0.06% in the 30-mg pioglitazone group and 0.61% in the placebo group. Compared to placebo, changes were significant in all active treatment groups (all p < 0.05). Increase in high-density lipoprotein cholesterol and decrease in triglyceride were observed in the rivoglitazone 1 and 1.5 mg groups, respectively, compared to placebo from baseline to week 12 (p < 0.05). Drug-related oedema was reported in eight patients (7.7%) in all rivoglitazone groups compared to six patients (16.2%) in the pioglitazone group and one patient (3.0%) in the placebo group. Conclusions: Rivoglitazone is an efficacious, safe and well-tolerated TZD which improved glycaemic control in Chinese type 2 diabetic patients up to 3 months.
- Subjects
RANDOMIZED controlled trials; PEROXISOMES; BLOOD lipids; TYPE 2 diabetes treatment; PLACEBOS; ANALYSIS of covariance; LIPOPROTEINS; TRIGLYCERIDES; PPAR-gamma agonists
- Publication
Diabetes, Obesity & Metabolism, 2011, Vol 13, Issue 9, p806
- ISSN
1462-8902
- Publication type
Article
- DOI
10.1111/j.1463-1326.2011.01411.x