A Study to Evaluate the Efficacy and Safety of Sitagliptin and MK0431A in Comparison to a Commonly Used Medication in Patients With Type 2 Diabetes (0431-068)(COMPLETED)

Merck Sharp & Dohme (MSD)

Status and phase: Completed; Phase 3

Conditions: Type 2 Diabetes Mellitus

Treatments: Drug: Comparator: pioglitazone; Drug: Comparator: sitagliptin phosphate (sitagliptin); Drug: Matching placebo to pioglitazone; Drug: Matching Placebo to Sita/Met FDC; Drug: Matching placebo to sitagliptin; Drug: sitagliptin phosphate (+) metformin hydrochloride

Study type: Interventional

Funder types: Industry

Identifiers

NCT00541450

2007_501

0431-068

Details and patient eligibility

About

The purpose of this study is to evaluate the efficacy and safety of sitagliptin and MK0431A in comparison to a commonly used medication in patients with type 2 diabetes.

Enrollment: 492 patients

Sex: All

Ages: 18 to 78 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patients between the ages of 18 and 78 with type 2 diabetes mellitus
• Patient has not been on any antihyperglycemic agent (Insulin or oral) in the last 3 months

Exclusion criteria

• Patient has a history of type 1 diabetes mellitus or a history of ketoacidosis
• Patient has previously been treated with sitagliptin or has previously been in a study using a DPP-4 inhibitor

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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492 participants in 2 patient groups

Sita/Met FDC

Experimental group

Description:

In Phase A (Treatment Day 1 to Week 12), participants were administered 100 mg once daily (q.d.) of sitagliptin and matching placebo to 15 mg pioglitazone q.d. for 6 weeks followed by matching placebo to 30 mg pioglitazone for the next 6 weeks. In Phase B (Treatment Week 12-Week 40), participants were switched to the Sita/Met Fixed-Dose Combination (FDC) at a dose of 50/500 mg twice a day (b.i.d.), which was increased to 50/1000 mg b.i.d. over a period of 4 weeks; as well as matching placebo to 45 mg pioglitazone.

Treatment:

Drug: sitagliptin phosphate (+) metformin hydrochloride

Drug: Matching placebo to pioglitazone

Drug: Comparator: sitagliptin phosphate (sitagliptin)

Pioglitazone

Active Comparator group

Description:

In Phase A (Treatment Day 1 up to Week 12), randomized participants in the pioglitazone group were administered 15 mg q.d. of pioglitazone and matching placebo to sitagliptin. At Week 6, participants were up-titrated to 30 mg pioglitazone q.d. In Phase B (Treatment Week 12 to Week 40), participants were administered 45 mg pioglitazone q.d.; as well as matching placebo to Sita/Met FDC (50/500 increased to 50/1000 b.i.d. after 4 weeks).

Treatment:

Drug: Matching placebo to sitagliptin

Drug: Matching Placebo to Sita/Met FDC

Drug: Comparator: pioglitazone