Mattoo, V 2005 Quality rating: Fair

Design:

Study design: RCT DB Parallel

  • Run-in : 90 days
  • Setting: Multicenter
  • Wash out : no days
  • Country: Multiple (US, Europe, Canada)

Sample: Number Screened/Eligible/Enrolled Number Withdrawn/Lost to follow-up/Analyzed

385/308/289 26/NR/276

Inclusion criteria:

DM2 diagnosed according to WHO criteria, used insulin therapy (with or without an oral antihyperglycemic medication for 3 months or longer, had HbA1c value 7.5% or higher at screening, and were 30 years or older at the time of diabetes diagnosis.

Exclusion criteria:

DM1, clinical signs or symptoms of any chronic systemic condition (liver disease, diminished cardiac function, renal impairment, transplantation or dialysis, HIV infection), or signs or symptoms of drug or alcohol abuse. Previous TZD use, systemic glucorticoid therapy, nicotinic acid at a dose >500 mg.d, or therapy for a malignancy other than basal cell or squamous cell skin cancer. Women who were breastfeeding or pregnant, women of childbearing potential not actively practicing birth control.

Comments:

Population:

  • Mean age: 58.9 years
  • Ethnicity: 96.5% white
  • Gender: 57% Female 3.5% other
  • Type 2 diabetes duration (SD): 162.1 (NR) years

Intervention: Added to insulin

Duration: 6 month

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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