Sitagliptin Added-on to Insulin Study (0431-051)

Phase 3 Completed 641 enrolled Merck Sharp & Dohme LLC

RandomizedParallel-groupDouble-blindTreatment

Summary

A clinical study to determine the safety and efficacy of sitagliptin in patients with Type 2 Diabetes Mellitus who have inadequate glycemic control on insulin or insulin/metformin combination therapy.

Timeline

Start: 2006-12-11
Primary completion: 2008-10-13
Completion: 2008-10-13

Outcome

Met primary endpoint

paper At 24 weeks, the addition of sitagliptin significantly (p < 0.001) reduced HbA1c by 0.6% compared with placebo (0.0%). PMID 20092585 ↗

registry Sitagliptin 100 mg q.d. vs Placebo; p <0.001; Mean Difference (Net) -0.56 (95% CI -0.70 to -0.42); ANCOVA NCT00395343 ↗

Publications

Results Vilsboll T, Rosenstock J, Yki-Jarvinen H, Cefalu WT, Chen Y, Luo E, Musser B, Andryuk PJ, Ling Y, Kaufman KD, Amatruda JM, Engel SS, Katz L. Efficacy and safety of sitagliptin when added to insulin therapy in patients with type 2 diabetes. Diabetes Obes Metab. 2010 Feb;12(2):167-77. doi: 10.1111/j.1463-1326.2009.01173.x.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Sitagliptin	Small molecule	100 mg	—