Clinical Study on Sitagliptin for Assessment of Glucose-lowering Effects (0431-045)

Phase 2 Completed 80 enrolled Merck Sharp & Dohme LLC

RandomizedParallel-groupDouble-blindTreatment

Summary

A clinical study determines the safety and efficacy of sitagliptin (MK0431) in patients with Type 2 diabetes mellitus who have inadequate glycemic control on diet/exercise therapy

Timeline

Start: 2005-07-03
Primary completion: 2006-02-13
Completion: 2006-02-13

Outcome

Met primary endpoint

registry Sitagliptin 100 mg QD vs Placebo; p <0.001; Least-squares Mean Difference -25.9 (95% CI -34.2 to -17.5) NCT00758069 ↗

registry Sitagliptin 50 mg BID vs Placebo; p <0.001; Least-squares Mean Difference -19.5 (95% CI -28.0 to -11.1) NCT00758069 ↗

Publications

Background Nonaka K, Tsubouchi H, Okuyama K, Fukao Y, Johnson-Levonas AO, Amatruda JM. Effects of once-daily sitagliptin on 24-h glucose control following 4 weeks of treatment in Japanese patients with type 2 diabetes mellitus. Horm Metab Res. 2009 Mar;41(3):232-7. doi: 10.1055/s-0028-1100413. Epub 2009 Feb 27.

Drugs

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