drugset / Trial / NCT00443755
Effect of Insulin Sensitizer Therapy on Atherothrombotic and Inflammatory Profiles Associated With Insulin Resistance
Phase 2
Completed
28 enrolled
Mayo Clinic
National Center for Research Resources (NCRR) · collabNational Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) · collabTakeda Pharmaceuticals North America, Inc. · collab
RandomizedParallel-groupDouble-blindTreatment
Summary
The objective of this study is to determine whether targeted pharmacological improvement of insulin sensitivity will normalize the associated elevations of thrombotic and inflammatory cardiovascular disease (CVD) biomarkers in individuals with insulin resistance.
Timeline
- Start
- 2005-08
- Primary completion
- 2010-08
- Completion
- 2010-08
Publications
- Results McCoy RG, Irving BA, Soop M, Srinivasan M, Tatpati L, Chow L, Weymiller AJ, Carter RE, Nair KS. Effect of insulin sensitizer therapy on atherothrombotic and inflammatory profiles associated with insulin resistance. Mayo Clin Proc. 2012 Jun;87(6):561-70. doi: 10.1016/j.mayocp.2012.02.014.
- Irving BA, Carter RE, Soop M, Weymiller A, Syed H, Karakelides H, Bhagra S, Short KR, Tatpati L, Barazzoni R, Nair KS. Effect of insulin sensitizer therapy on amino acids and their metabolites. Metabolism. 2015 Jun;64(6):720-8. doi: 10.1016/j.metabol.2015.01.008. Epub 2015 Jan 22.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Metformin | Small molecule | 1 g | — |
| Comparator | Pioglitazone | Small molecule | 45 mg | — |