drugset / Trial / NCT00397631
Initial Combination With Pioglitazone Study (0431-064)
RandomizedParallel-groupDouble-blindTreatment
Summary
A clinical study to evaluate the safety and efficacy of the initial combination therapy with sitagliptin and pioglitazone in patients with type 2 diabetes mellitus not on treatment with insulin or oral antihyperglycemic therapy.
Timeline
- Start
- 2006-12-19
- Primary completion
- 2008-06-28
- Completion
- 2008-06-28
Outcome
Met primary endpoint
registry Sitagliptin 100 mg q.d. + Pioglitazone 30 mg q.d. vs Pioglitazone 30 mg q.d.; p <0.001; Mean Difference (Net) -0.89 (95% CI -1.13 to -0.65); ANCOVA NCT00397631 ↗
paper Initial combination therapy with sitagliptin and pioglitazone led to a mean reduction from baseline in A1C of -2.4% compared with -1.5% for pioglitazone monotherapy (p<0.001). PMID 21235696 ↗
Publications
- Results Yoon KH, Shockey GR, Teng R, Golm GT, Thakkar PR, Meehan AG, Williams-Herman DE, Kaufman KD, Amatruda JM, Steinberg H. Effect of initial combination therapy with sitagliptin, a dipeptidyl peptidase-4 inhibitor, and pioglitazone on glycemic control and measures of beta-cell function in patients with type 2 diabetes. Int J Clin Pract. 2011 Feb;65(2):154-64. doi: 10.1111/j.1742-1241.2010.02589.x.
- Yoon KH, Steinberg H, Teng R, Golm GT, Lee M, O'Neill EA, Kaufman KD, Goldstein BJ. Efficacy and safety of initial combination therapy with sitagliptin and pioglitazone in patients with type 2 diabetes: a 54-week study. Diabetes Obes Metab. 2012 Aug;14(8):745-52. doi: 10.1111/j.1463-1326.2012.01594.x. Epub 2012 Apr 17.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Pioglitazone | Small molecule | 30 mg | Oral |
| Subject | Sitagliptin | Small molecule | 100 mg | Oral |