Initial Combination With Pioglitazone Study (0431-064)

Merck Sharp & Dohme (MSD)

Status and phase: Completed; Phase 3

Conditions: Type 2 Diabetes Mellitus

Treatments: Drug: Comparator: placebo to match sitagliptin 100 mg q.d./pioglitazone 30 mg q.d.; Drug: sitagliptin 100 mg q.d./pioglitazone 30 mg q.d

Study type: Interventional

Funder types: Industry

Identifiers

NCT00397631

0431-064

MK0431-064

2006_531

Details and patient eligibility

About

A clinical study to evaluate the safety and efficacy of the initial combination therapy with sitagliptin and pioglitazone in patients with type 2 diabetes mellitus not on treatment with insulin or oral antihyperglycemic therapy.

Enrollment: 520 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

General Inclusion Criteria:

• Patients ≥18 years old with Type 2 Diabetes Mellitus (a specific type of diabetes)

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 4 months
• Patient was on >4 weeks (cumulatively) of antihyperglycemic therapy (oral or insulin) over the prior 2 years

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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520 participants in 2 patient groups

1

Experimental group

Description:

sitagliptin 100 mg q.d./pioglitazone 30 mg q.d.

Treatment:

Drug: sitagliptin 100 mg q.d./pioglitazone 30 mg q.d

2

Active Comparator group

Description:

sitagliptin 100 mg placebo q.d./pioglitazone 30 mg q.d.

Treatment:

Drug: Comparator: placebo to match sitagliptin 100 mg q.d./pioglitazone 30 mg q.d.