MK0431A Comparative Study in Patients With Type 2 Diabetes (0431A-079)(COMPLETED)

Merck Sharp & Dohme (MSD)

Status and phase: Completed; Phase 3

Conditions: Type 2 Diabetes Mellitus

Treatments: Drug: sitagliptin phosphate (+) metformin hydrochloride; Drug: metformin

Study type: Interventional

Funder types: Industry

Identifiers

NCT00482729

2007_548

MK0431A-079

0431A-079

Details and patient eligibility

About

The purpose of this study is to investigate the efficacy and safety of an investigational treatment for type 2 diabetes mellitus.

Enrollment: 1,246 patients

Sex: All

Ages: 18 to 78 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patient has type 2 diabetes mellitus
• Patient is greater than or equal to 18 and less than or equal to 78 years of age on the day of signing the consent
• Patient has Hb1Ac greater than or equal to 7.5% and is appropriate for oral therapy
• Patient has not been on any antihyperglycemic agent (AHA) in the last 4 months
• Patient is a male, or a female who is unlikely to conceive

Exclusion criteria

• Patient has type 1 diabetes mellitus or history of ketoacidosis

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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1,246 participants in 2 patient groups

1

Experimental group

Description:

Arm 1: drug

Treatment:

Drug: sitagliptin phosphate (+) metformin hydrochloride

2

Active Comparator group

Description:

Arm 2: active comparator

Treatment:

Drug: metformin