NCT01590797View on ClinicalTrials.gov

A Study in China Evaluating the Safety and Efficacy of Adding Sitagliptin to Stable Therapy With Insulin With or Without Metformin in Participants With Type 2 Diabetes Mellitus (T2DM) (MK-0431-254)

PHASE3CompletedINTERVENTIONAL

Enrollment

467

Participants

Timeline

Start Date

July 10, 2012

Primary Completion Date

June 11, 2014

Study Completion Date

June 25, 2014

Conditions

Type 2 Diabetes Mellitus

Interventions

DRUG

Sitagliptin

Sitagliptin 100 mg once daily for 24 weeks

DRUG

Placebo

Matching placebo once daily for 24 weeks

BIOLOGICAL

Insulin

Participants can be on on pre-mixed (mixture of rapid- and long-acting insulin) or intermediate- or long-acting insulin at a dose of at least 12 U/day.

DRUG

Metformin

At randomization, participants will be stratified according to their use of metformin (on or not on). All participants receiving metformin will be required to be on a daily dose of metformin at least 1500 mg per day.

All Listed Sponsors

lead

Merck Sharp & Dohme LLC

INDUSTRY

NCT01590797 - A Study in China Evaluating the Safety and Efficacy of Adding Sitagliptin to Stable Therapy With Insulin With or Without Metformin in Participants With Type 2 Diabetes Mellitus (T2DM) (MK-0431-254) | Biotech Hunter | Biotech Hunter