Metformin Add-on Study in Patients With Type 2 Diabetes Mellitus (0431-020)(COMPLETED)

Merck Sharp & Dohme (MSD)

Status and phase: Completed; Phase 3

Conditions: Diabetes Mellitus, Type II

Treatments: Drug: Metformin; Drug: Sitagliptin (MK0431); Drug: Placebo/Glipizide 5 mg; Drug: Pioglitazone

Study type: Interventional

Funder types: Industry

Identifiers

NCT00086515

0431-020

Formally-B0604T2DMT

2006_411

Details and patient eligibility

About

The purpose of this study is to determine the safety and efficacy of an investigational drug in patients with type 2 diabetes mellitus.

Enrollment: 701 patients

Sex: All

Ages: 18 to 78 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria:

• Patients with type 2 diabetes mellitus

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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701 participants in 2 patient groups, including a placebo group

Sitagliptin 100 mg

Experimental group

Description:

The Sitagliptin 100 mg group includes patients who were administered once-daily treatment with oral tablets of sitagliptin 100 mg during Phase A (Weeks 0-24) of the treatment period. During Phase B (Weeks 24-104) of the treatment period these patients received once-daily coadministered treatment with oral tablets of sitagliptin 100 mg and glipizide-matched placebo.

Treatment:

Drug: Metformin

Drug: Pioglitazone

Drug: Sitagliptin (MK0431)

Placebo / Glipizide 5 mg

Placebo Comparator group

Description:

The Placebo/Glipizide 5 mg group includes patients who were administered once-daily treatment with oral tablets of sitagliptin-matched placebo during Phase A (Weeks 0-24) of the treatment period. During Phase B (Weeks 24-104) of the treatment period these patients received once-daily coadministered treatment with oral tablets of sitagliptin-matched placebo 100 mg and glipizide 5 mg which was allowed to be uptitrated, in a blinded fashion, to a maximum dose of 15 mg/day.

Treatment:

Drug: Metformin

Drug: Placebo/Glipizide 5 mg

Drug: Pioglitazone