Fonseca V 2000 Quality rating: Fair

Design:

Study design: RCT DB Parallel

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

Sample: Number Screened/Eligible/Enrolled Number Withdrawn/Lost to follow-up/Analyzed

443/410/348 51/7/348

Inclusion criteria:

Persons with DM2 between 40 and 80 years of age, with FPG 7.8–16.7 mmol/L at screening and during the placebo-maintenance period while taking 2.5 g/d of metformin; fasting C-peptide ≥ 0.27 nmol/L; BMI 22–38; weight change of no more than 10% between screening and baseline

Exclusion criteria:

Significant renal or hepatic disease, angina, New York Heart Association Class III or IV cardiac insufficiency, symptomatic diabetic neuropathy, significant clinical ECG abnormality, abnormal laboratory test results (blood chemistry, hematology, urinalysis); chronic use of insulin therapy; participated in any Rosi-related study; used an investigational drug (excluding metformin) within 30d of study; anorectic agents were discontinued ≥ 30d before screening; lipid-lowering agents were maintained at same dosage level throughout the study

Comments:

Setting:

36 sites in USA.

Population:

  • Mean age: 58 years
  • Ethnicity: 80% White, 7% Black, 13% other
  • Gender: 32% Female
  • Type 2 diabetes duration (SD): 7.3 (5.7) years

Intervention: added to metformin

Duration: 26 week

Table

Laboratory measures:

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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