A Study in China Evaluating the Safety and Efficacy of Adding Sitagliptin to Stable Therapy With Sulfonylurea With or Without Metformin in Participants With Type 2 Diabetes Mellitus (T2DM) (MK-0431-253)

Summary

A study to compare safety and efficacy of sitagliptin and placebo therapy when added to stable sulfonylurea alone or in combination with metformin in participants with type 2 diabetes mellitus (T2DM). The primary hypothesis of this study is that after 24 weeks, the addition of sitagliptin compared with placebo provides greater reduction in hemoglobin A1C (HbA1C) in T2DM participants on sulfonylurea alone or in combination with metformin.

Timeline

Start

2012-07-09

Primary completion

2014-06-10

Completion

2014-06-24

Outcome

Met primary endpoint

registry Sitagliptin vs Placebo; p <0.001; Robust regression -0.61 (95% CI -0.77 to -0.44) NCT01590771 ↗

paper After 24 weeks, sitagliptin reduced HbA1c, FPG, and 2-h PMG significantly more than placebo PMID 27502307 ↗

Publications

• Results Ba J, Han P, Yuan G, Mo Z, Pan C, Wu F, Xu L, Hanson ME, Engel SS, Shankar RR. Randomized trial assessing the safety and efficacy of sitagliptin in Chinese patients with type 2 diabetes mellitus inadequately controlled on sulfonylurea alone or combined with metformin. J Diabetes. 2017 Jul;9(7):667-676. doi: 10.1111/1753-0407.12456. Epub 2016 Sep 13.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Sitagliptin	Small molecule	100 mg	Oral
Background	Gliclazide	Small molecule	—	—
Background	Glimepiride	Small molecule	—	—
Background	Metformin	Small molecule	1500 mg	—

Indications