drugset / Trial / NCT00225264
Efficacy Study of Pioglitazone and Glimepiride on the Rate of Progression of Atherosclerotic Disease.
RandomizedParallel-groupQuadruple-blindTreatment
Summary
The primary purpose of this study is to compare the effects of pioglitazone, once daily (QD), versus glimepiride on the amount of thickening of the carotid artery.
Timeline
- Start
- 2003-10
- Primary completion
- 2006-05
- Completion
- 2006-05
Outcome
Met primary endpoint
paper At week 72, the primary end point of progression of mean CIMT was less with pioglitazone vs glimepiride PMID 17101640 ↗
paper -0.001 mm vs +0.012 mm, respectively; difference, -0.013 mm; 95% confidence interval, -0.024 to -0.002; P = .02 PMID 17101640 ↗
Publications
- Results Mazzone T, Meyer PM, Feinstein SB, Davidson MH, Kondos GT, D'Agostino RB Sr, Perez A, Provost JC, Haffner SM. Effect of pioglitazone compared with glimepiride on carotid intima-media thickness in type 2 diabetes: a randomized trial. JAMA. 2006 Dec 6;296(21):2572-81. doi: 10.1001/jama.296.21.joc60158. Epub 2006 Nov 13.
- Results Davidson M, Meyer PM, Haffner S, Feinstein S, D'Agostino R Sr, Kondos GT, Perez A, Chen Z, Mazzone T. Increased high-density lipoprotein cholesterol predicts the pioglitazone-mediated reduction of carotid intima-media thickness progression in patients with type 2 diabetes mellitus. Circulation. 2008 Apr 22;117(16):2123-30. doi: 10.1161/CIRCULATIONAHA.107.746610. Epub 2008 Apr 14.
- Results Sam S, Haffner S, Davidson MH, D'Agostino RB Sr, Feinstein S, Kondos G, Perez A, Mazzone T. Relationship of abdominal visceral and subcutaneous adipose tissue with lipoprotein particle number and size in type 2 diabetes. Diabetes. 2008 Aug;57(8):2022-7. doi: 10.2337/db08-0157. Epub 2008 May 9.
- Results Mazzone T, Meyer PM, Kondos GT, Davidson MH, Feinstein SB, D'Agostino RB Sr, Perez A, Haffner SM. Relationship of traditional and nontraditional cardiovascular risk factors to coronary artery calcium in type 2 diabetes. Diabetes. 2007 Mar;56(3):849-55. doi: 10.2337/db06-0935.
- Results Sam S, Haffner S, Davidson MH, D'Agostino RB Sr, Feinstein S, Kondos G, Perez A, Mazzone T. Relation of abdominal fat depots to systemic markers of inflammation in type 2 diabetes. Diabetes Care. 2009 May;32(5):932-7. doi: 10.2337/dc08-1856. Epub 2009 Feb 19.
- 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.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Glimepiride | Small molecule | 4 mg | Oral |
| Subject | Pioglitazone | Small molecule | 45 mg | Oral |