title: A randomized-controlled trial to investigate the effects of rivoglitazone, a novel PPAR gamma agonist on glucose-lipid control in type 2 diabetes.
abstract: OBJECTIVE
  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.
authors.affiliation: Department of Medicine and Therapeutics, Prince of Wales Hospital, The Chinese University of Hong Kong, Shatin, Hong Kong, China.
authors.forename: A P S
authors.initials: AP
authors.lastname: Kong
authors.forename: A
authors.initials: A
authors.lastname: Yamasaki
authors.forename: R
authors.initials: R
authors.lastname: Ozaki
authors.forename: H
authors.initials: H
authors.lastname: Saito
authors.forename: T
authors.initials: T
authors.lastname: Asami
authors.forename: S
authors.initials: S
authors.lastname: Ohwada
authors.forename: G T C
authors.initials: GT
authors.lastname: Ko
authors.forename: C K
authors.initials: CK
authors.lastname: Wong
authors.forename: G T C
authors.initials: GT
authors.lastname: Leung
authors.forename: K F
authors.initials: KF
authors.lastname: Lee
authors.forename: C Y
authors.initials: CY
authors.lastname: Yeung
authors.forename: J C N
authors.initials: JC
authors.lastname: Chan
mesh_terms: D000328:Adult; D000368:Aged; D044466:Asian People; D001786:Blood Glucose / Q000187:drug effects* / Q000378:metabolism; D003924:Diabetes Mellitus, Type 2 / Q000188:drug therapy* / Q000378:metabolism; D004311:Double-Blind Method; D005260:Female; D006442:Glycated Hemoglobin / Q000187:drug effects* / Q000378:metabolism; D006801:Humans; D007004:Hypoglycemic Agents / Q000008:administration & dosage* / Q000494:pharmacology; D050356:Lipid Metabolism / Q000187:drug effects*; D008297:Male; D008875:Middle Aged; D047495:PPAR gamma / Q000819:agonists*; D000077205:Pioglitazone; D045162:Thiazolidinediones / Q000008:administration & dosage* / Q000494:pharmacology; D016896:Treatment Outcome; D055815:Young Adult
chemical_list: D001786:Blood Glucose; D006442:Glycated Hemoglobin; D007004:Hypoglycemic Agents; D047495:PPAR gamma; D000077205:Pioglitazone; D045162:Thiazolidinediones; C521549:rivoglitazone