Lester JW 2005 Quality rating: Fair


Study design: RCT DB Parallel

  • Run-in : NR
  • Setting: Multicenter
  • Wash out : NR
  • Country: USA

Sample: Number Screened/Eligible/Enrolled Number Withdrawn/Lost to follow-up/Analyzed


Inclusion criteria:

Male and female patients with DM2 inadequately managed with metformin at ≥ 50% of maximum tolerated dose for ≥ 3m; 35–75y; a1c ≥ 7.5% of ≤ 11%; fasting C-peptide ≥ 1.5 ng/ml; stable or worsening glycemic control for ≥ 3m.

Exclusion criteria:

DM1; ketoacidoses, MI, TIA or stroke in last 6m; symptomatic heart failure; acute malabsorption or chronic pancreatitis; familial polyposis coli, malignant disease in the last 10y; substance abuse; potential of pregnancy; breast-feeding.


Report of 4 other RCTs: Hanefeld 2004, Matthews 2004, Schernthaner, Charbonnel 2005

This study is reported separately, although overlaps other reports, as examines subgroup with DM2 and metabolic syndrome

Quality assessment: based on 4 primary studies, all of fair quality

Contains data on subset of 4 original studies with DM2 and metabolic syndrome: 3186 out of original 3713 patients (86%)


  • Mean age: NR years
  • Ethnicity: NR
  • Gender: 0% Female
  • Type 2 diabetes duration (SD): NR

Intervention: 4 other studies, DM2 +MS

Laboratory measures:


Physiologic outcomes:


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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