Tan M (glimepiride) 2004 Quality rating: Fair


Study design: RCT DB Parallel

  • Run-in: 7–21 days
  • Setting: Multicenter
  • Wash out: None
  • Country: Mexico

Sample: Number Screened/Eligible/Enrolled Number Withdrawn/Lost to follow-up/Analyzed

584/244/244 51/17/208

Inclusion criteria:

Patients with DM2 with A1c >7.5% and ≤ 11.0% in patients who were not receiving oral hypoglycemic agents, and >7.5% and ≤ 9.5% in patients who were receiving oral agents. Patients must have had a trial of diet and lifestyle interventions before study enrollment.

Exclusion criteria:

Treatment with a TZD or insulin within the previous 3 months, current prescription for a maximum dose of an oral agent or for combination oral therapy; treatment with oral or parenteral glucocorticosheroids within the last 30 days; cardiac disease with significant functional limitation (NR Heart Association Class III or IV; triglycerides >400 mg/dl; serum creatinine >2.0 mg/dl; renal transplantation or current renal dialysis; ALT or AST > 2.5 times upper limit of normal; clinical signs or symptoms of liver disease; Hg<115 g/l for women and <115g/l for men; BMI <25 or >35 kg/m2; signs or symptoms of substance abuse


Data are reported for ITT: all randomized patients who received ≥1 dose of study medication and had a baseline and ≥ 1 efficacy measurement; completers also reported (data not abstracted)


  • Mean age: 55.3 years
  • Ethnicity: Hispanic 99%, white 1%
  • Gender: 51% Female
  • Type 2 diabetes duration (SD): 6.7 (NR) years

Intervention: monotherapy



Laboratory measures:


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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