Safety and Efficacy of Co-Administration of Sitagliptin and Metformin in China (MK-0431-121)

Summary

This study will assess the efficacy and safety of initial treatment with sitagliptin and metformin in patients with type 2 diabetes mellitus in China. The primary hypothesis is that after 24 weeks, initial co-administration treatment with sitagliptin and metformin provided greater reduction in hemoglobin A1C (A1C) compared to initial treatment with sitagliptin alone and with metformin alone.

Timeline

Start

2010-11-15

Primary completion

2012-12-24

Completion

2012-12-24

Outcome

Met primary endpoint

registry analysis (superiority or other test); Sitagliptin 50 mg + Metformin 850 mg vs Placebo; p <0.001; Difference in Least Squares Mean -1.24 NCT01076088 ↗

registry analysis (superiority or other test); Sitagliptin 50 mg + Metformin 500 mg vs Placebo; p <0.001; Difference in Least Squares Mean -1.08 NCT01076088 ↗

Publications

• Results Ji L, Han P, Wang X, Liu J, Zheng S, Jou YM, O'Neill EA, Golm GT, Engel SS, Kaufman KD, Shankar RR. Randomized clinical trial of the safety and efficacy of sitagliptin and metformin co-administered to Chinese patients with type 2 diabetes mellitus. J Diabetes Investig. 2016 Sep;7(5):727-36. doi: 10.1111/jdi.12511. Epub 2016 May 19.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Metformin	Small molecule	500 mg	—
Subject	Metformin	Small molecule	850 mg	—
Subject	Sitagliptin	Small molecule	50 mg	—
Subject	Sitagliptin	Small molecule	100 mg	—

Indications