Sitagliptin Metformin/PPARg Agonist Combination Therapy Add-on (0431-052)

Phase 3 Completed 262 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 metformin/peroxisome proliferator-activated receptor gamma (PPARg) agonist combination therapy.

Timeline

Start: 2006-06-12
Primary completion: 2007-09-25
Completion: 2008-06-11

Outcome

Met primary endpoint

registry analysis (superiority or other test); Sitagliptin 100 mg vs Placebo; p <0.001; Mean Difference (Net) -0.72 (95% CI -0.95 to -0.49); ANCOVA NCT00350779 ↗

paper The mean placebo-adjusted change from baseline in HbA1c with sitagliptin treatment was -0.7% (P < 0.001) at Week 18 PMID 22742523 ↗

Publications

Dobs AS, Goldstein BJ, Aschner P, Horton ES, Umpierrez GE, Duran L, Hill JS, Chen Y, Golm GT, Langdon RB, Williams-Herman DE, Kaufman KD, Amatruda JM, Ferreira JC. Efficacy and safety of sitagliptin added to ongoing metformin and rosiglitazone combination therapy in a randomized placebo-controlled 54-week trial in patients with type 2 diabetes. J Diabetes. 2013 Mar;5(1):68-79. doi: 10.1111/j.1753-0407.2012.00223.x.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Sitagliptin	Small molecule	100 mg	—
Background	Glipizide	Small molecule	5 mg	—
Background	Glipizide	Small molecule	40 mg	—
Background	Metformin	Small molecule	1500 mg	—
Background	Rosiglitazone	Small molecule	4 mg	—