drugset / Trial / NCT00225277
Efficacy Study of Pioglitazone Compared to Glimepiride on Coronary Atherosclerotic Disease Progression in Subjects With Type 2 Diabetes Mellitus
RandomizedParallel-groupQuadruple-blindTreatment
Summary
The purpose of this study was to determine the efficacy of pioglitazone, once daily (QD), compared to glimepiride on atherosclerotic disease measured by intravascular ultrasound.
Timeline
- Start
- 2003-07
- Primary completion
- 2007-10
- Completion
- 2007-10
Outcome
Met primary endpoint
paper Least squares mean PAV increased 0.73% (95% CI, 0.33% to 1.12%) with glimepiride and decreased 0.16% (95% CI, -0.57% to 0.25%) with pioglitazone(P = .002). PMID 18378631 ↗
registry analysis (superiority or other test); Pioglitazone QD vs Glimepiride QD; p = 0.002; Mean Difference (Final Values) -0.886 (95% CI -1.4480 to -0.3250); ANCOVA NCT00225277 ↗
Publications
- Results Nissen SE, Nicholls SJ, Wolski K, Nesto R, Kupfer S, Perez A, Jure H, De Larochelliere R, Staniloae CS, Mavromatis K, Saw J, Hu B, Lincoff AM, Tuzcu EM; PERISCOPE Investigators. Comparison of pioglitazone vs glimepiride on progression of coronary atherosclerosis in patients with type 2 diabetes: the PERISCOPE randomized controlled trial. JAMA. 2008 Apr 2;299(13):1561-73. doi: 10.1001/jama.299.13.1561. Epub 2008 Mar 31.
- Results Betteridge DJ. CHICAGO, PERISCOPE and PROactive: CV risk modification in diabetes with pioglitazone. Fundam Clin Pharmacol. 2009 Dec;23(6):675-9. doi: 10.1111/j.1472-8206.2009.00741.x. Epub 2009 Sep 10.
- Results Nicholls SJ, Tuzcu EM, Wolski K, Bayturan O, Lavoie A, Uno K, Kupfer S, Perez A, Nesto R, Nissen SE. Lowering the triglyceride/high-density lipoprotein cholesterol ratio is associated with the beneficial impact of pioglitazone on progression of coronary atherosclerosis in diabetic patients: insights from the PERISCOPE (Pioglitazone Effect on Regression of Intravascular Sonographic Coronary Obstruction Prospective Evaluation) study. J Am Coll Cardiol. 2011 Jan 11;57(2):153-9. doi: 10.1016/j.jacc.2010.06.055.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Glimepiride | Small molecule | 4 mg | Oral |
| Subject | Pioglitazone | Small molecule | 45 mg | Oral |