A Study of an Investigational Drug Sitagliptin for Type 2 Diabetes Mellitus (0431-044)

Phase 2 Completed 363 enrolled Merck Sharp & Dohme LLC

RandomizedParallel-groupDouble-blindTreatment

Summary

The purpose of this trial is to determine the efficacy and safety of an investigational drug in patients with type 2 diabetes mellitus.

Timeline

Start: 2005-07
Primary completion: 2006-03
Completion: 2006-03

Outcome

Met primary endpoint

registry analysis (superiority or other test); Sitagliptin 200 mg QD vs Placebo; p <0.001; Least-squares Mean Difference -1.04 (95% CI -1.21 to -0.86) NCT00127192 ↗

paper At Week 12, treatment with sitagliptin at all doses tested provided significant (p<0.001) reductions in HbA(1c) PMID 20332588 ↗

Publications

Results Iwamoto Y, Taniguchi T, Nonaka K, Okamoto T, Okuyama K, Arjona Ferreira JC, Amatruda J. Dose-ranging efficacy of sitagliptin, a dipeptidyl peptidase-4 inhibitor, in Japanese patients with type 2 diabetes mellitus. Endocr J. 2010;57(5):383-94. doi: 10.1507/endocrj.k09e-272. Epub 2010 Mar 24.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Sitagliptin	Small molecule	25 mg	Oral
Subject	Sitagliptin	Small molecule	50 mg	Oral
Subject	Sitagliptin	Small molecule	100 mg	Oral
Subject	Sitagliptin	Small molecule	200 mg	Oral