MK0431A vs. Pioglitazone in Patients With Type 2 Diabetes Mellitus (0431A-066)

Merck Sharp & Dohme (MSD)

Status and phase: Completed; Phase 3

Conditions: Type 2 Diabetes Mellitus

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

Study type: Interventional

Funder types: Industry

Identifiers

NCT00532935

0431A-066

2007_510

Details and patient eligibility

About

A study to evaluate the efficacy and safety of MK0431A in comparison to a commonly used medication in patients with type 2 diabetes

Enrollment: 517 patients

Sex: All

Ages: 18 to 78 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

General Inclusion Criteria:

• Patient has type 2 diabetes mellitus
• Patient is inadequately controlled and not on treatment with insulin or oral antihyperglycemic therapy

General Exclusion Criteria:

• Patient has a history of type 1 diabetes mellitus or history of ketoacidosis
• Patient was on antihyperglycemic agent therapy (oral or insulin) within the prior 12 weeks
• Patient was on >4 weeks (cumulatively) of antihyperglycemic therapy (oral or insulin) over the prior 3 years

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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517 participants in 2 patient groups

1

Experimental group

Description:

Sitagliptin phosphate (+) metformin hydrochloride

Treatment:

Drug: sitagliptin phosphate (+) metformin hydrochloride

2

Active Comparator group

Description:

pioglitazone

Treatment:

Drug: Comparator: pioglitazone