Lebovitz, H, 2001 Quality rating: Poor

Design:

Study design: RCT DB Parallel

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

Sample: Number Screened/Eligible/Enrolled Number Withdrawn/Lost to follow-up/Analyzed

NR/NR/623 90/NR/493

Inclusion criteria:

Patients with a fasting glucose between 7.8–16.7 mmol/l, fasting plasma C-peptide level greater than 0.26 nmol/l, BMI between 22–38 kg/m at screen.

Exclusion criteria:

Patients with angina or cardiac insufficiency, renal impairment, hepatic disease, history of diabetic ketoacidosis, history of chronic insulin use, symptomatic diabetic neuropathy, a serious major illness compromising study participation, women of child-bearing potential.

Comments:

Population:

  • Mean age: 60 years
  • Ethnicity: White 74.2%; Black 8.7%; Other 17.0%
  • Gender: 48% Female
  • Type 2 diabetes duration (SD): 4.93 (NR) years

Intervention: monotherapy

Duration: 26 week

Table

Laboratory measures:

Table

Laboratory measures:

Table

Physiologic outcomes:

Table

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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