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A randomized‐controlled trial to investigate the effects of rivoglitazone, a novel PPAR gamma agonist on glucose–lipid control in type 2 diabetes
Author(s) -
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.
Publication year - 2011
Publication title -
diabetes, obesity and metabolism
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 2.445
H-Index - 128
eISSN - 1463-1326
pISSN - 1462-8902
DOI - 10.1111/j.1463-1326.2011.01411.x
Subject(s) - pioglitazone , placebo , tolerability , medicine , type 2 diabetes , triglyceride , randomized controlled trial , clinical endpoint , dyslipidemia , thiazolidinedione , lipid profile , placebo controlled study , diabetes mellitus , endocrinology , gastroenterology , cholesterol , adverse effect , double blind , alternative medicine , pathology
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.