Jones, T 2003 Quality rating: Fair

Design:

Study design: RCT DB Open

  • Run-in : 28 days
  • Setting: NR
  • Wash out : NR
  • Country: USA

Sample: Number Screened/Eligible/Enrolled Number Withdrawn/Lost to follow-up/Analyzed

NR/NR/550 NR/NR/548

Inclusion criteria:

Patients of non-child-bearing potential, aged 40–80 years, diagnosed with DM2, fasting C-peptide >0.8 ng/ml at screening, maintaining a FPG level (between >140 mg/dL- <300 mg/dL) prior to randomization.

Exclusion criteria:

Patients with clinically significant renal or hepatic disease, angina, cardiac insufficiency, symptomatic diabetic neuropathy, significant clinical abnormality on electocardiogram, history of chronic insulin therapy, participation in any previous RSG-related studies, use of any investigational drug within 30 days of study.

Comments:

Population:

  • Mean age: 59.9 years
  • Ethnicity: NR
  • Gender: 32% Female
  • Type 2 diabetes duration (SD): NR (NR) years

Intervention: added to metformin

Duration: 6 month

Laboratory measures:

P value NR if not specified.

From: Evidence Tables

Cover of Drug Class Review: Thiazolidinediones
Drug Class Review: Thiazolidinediones: Final Report Update 1 [Internet].
Norris SL, Carson S, Thakurta S, et al.
Portland (OR): Oregon Health & Science University; 2008 Aug.
Copyright © 2008, Oregon Health & Science University, Portland, Oregon.

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