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

Merck Sharp & Dohme (MSD)

Status and phase: Completed; Phase 3

Conditions: Type 2 Diabetes Mellitus

Treatments: Drug: Sitagliptin 50 mg; Drug: Placebo; Drug: Metformin 500 mg; Drug: Metformin 850 mg; Drug: Sitagliptin 100 mg

Study type: Interventional

Funder types: Industry

Identifiers

NCT01076088

0431-121

2010_514 (Other Identifier)

Details and patient eligibility

About

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.

Enrollment: 744 patients

Sex: All

Ages: 18 to 78 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• has type 2 diabetes mellitus
• is male, a female who cannot have children, or a female who agrees to use birth control during the study
• is not on an antihyperglycemic agent (AHA) (hemoglobin A1c [A1C] 7.5-11.0%) or on oral single AHA (A1C 7.0-10.5%) or low-dose AHA combination therapy (A1C 7.0-10.0%)

Exclusion criteria

• Patient has type 1 diabetes mellitus or ketoacidosis
• Patient is taking a dipeptidyl peptidase-4 (DPP-4) inhibitor (such as sitagliptin)
• Patient is on a weight loss program not in the maintenance phase or on a weight loss medication
• Patient has a history of liver disease, heart failure, heart disease, stroke, high blood pressure, blood disorders, or cancer
• Patient is HIV positive
• Patient is pregnant

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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744 participants in 6 patient groups, including a placebo group

Sitagliptin 50 mg + metformin 500 mg

Experimental group

Description:

Sitagliptin 50 mg and metformin 500 mg twice a day for 24 weeks.

Treatment:

Drug: Metformin 500 mg

Drug: Sitagliptin 50 mg

Sitagliptin 50 mg + metformin 850 mg

Experimental group

Description:

Sitagliptin 50 mg and metformin 850 mg twice a day for 24 weeks.

Treatment:

Drug: Metformin 850 mg

Drug: Sitagliptin 50 mg

Metformin 500 mg

Active Comparator group

Description:

Metformin 500 mg twice daily for 24 weeks.

Treatment:

Drug: Metformin 500 mg

Metformin 850 mg

Active Comparator group

Description:

Metformin 850 mg twice daily for 24 weeks.

Treatment:

Drug: Metformin 850 mg

Sitagliptin 100 mg

Experimental group

Description:

Sitagliptin 100 mg once daily for 24 weeks.

Treatment:

Drug: Sitagliptin 100 mg

Placebo

Placebo Comparator group

Description:

Matching placebo tablets for 24 weeks.

Treatment:

Drug: Placebo