MK0431 Monotherapy Study in Patients With Type 2 Diabetes Mellitus (0431-040)

Summary

This is a clinical study to determine the safety and efficacy of an investigational drug in patients with type 2 diabetes mellitus.

Timeline

Start

2006-03

Primary completion

2007-03

Completion

2007-03

Outcome

Met primary endpoint

registry analysis (superiority or other test); Sitagliptin 100 mg vs Placebo; p <0.001; Mean Difference (Net) -1.03 (95% CI -1.23 to -0.83); ANCOVA NCT00289848 ↗

Publications

• Background Mohan V, Yang W, Son HY, Xu L, Noble L, Langdon RB, Amatruda JM, Stein PP, Kaufman KD. Efficacy and safety of sitagliptin in the treatment of patients with type 2 diabetes in China, India, and Korea. Diabetes Res Clin Pract. 2009 Jan;83(1):106-16. doi: 10.1016/j.diabres.2008.10.009. Epub 2008 Dec 20.
• Singh B, Sims H, Trueheart I, Simpson K, Wang KC, Patzkowsky K, Wegman T, Soma JM, Dixon R, Jayes F, Voegltine K, Yenokyan G, Su SC, Leppert P, Segars JH. A Phase I Clinical Trial to Assess Safety and Tolerability of Injectable Collagenase in Women with Symptomatic Uterine Fibroids. Reprod Sci. 2021 Sep;28(9):2699-2709. doi: 10.1007/s43032-021-00573-8. Epub 2021 Apr 29.

Drugs

Indications