An Investigational Drug Study in Patients With Type 2 Diabetes Mellitus (MK0431-023)

Summary

The purpose of this study is to determine the safety and effectiveness of an investigational drug in patients with Type 2 Diabetes Mellitus.

Timeline

Start

2004-10-06

Primary completion

2005-08-17

Completion

2006-04-28

Outcome

Met primary endpoint

registry Sitagliptin 100 mg vs Placebo/Pioglitazone; p <0.001; Mean Difference (Net) -0.60 (95% CI -0.82 to -0.39) NCT00094757 ↗

registry Sitagliptin 200 mg vs Placebo/Pioglitazone; p <0.001; Mean Difference (Net) -0.48 (95% CI -0.70 to -0.26) NCT00094757 ↗

Publications

• Background Raz I, Hanefeld M, Xu L, Caria C, Williams-Herman D, Khatami H; Sitagliptin Study 023 Group. Efficacy and safety of the dipeptidyl peptidase-4 inhibitor sitagliptin as monotherapy in patients with type 2 diabetes mellitus. Diabetologia. 2006 Nov;49(11):2564-71. doi: 10.1007/s00125-006-0416-z. Epub 2006 Sep 26.

Drugs

Evaluation	Drug	Modality	Dose	Route
Comparator	Pioglitazone	Small molecule	30 mg	Oral
Subject	Sitagliptin	Small molecule	100 mg	Oral
Subject	Sitagliptin	Small molecule	200 mg	Oral

Indications