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

Phase 3

Completed

• Conditions: Diabetes Mellitus, Type II
• Interventions: Drug: Sitagliptin (MK0431); Drug: Placebo/Glipizide 5 mg; Drug: Metformin; Drug: Pioglitazone

• Registration Number: NCT00086515
• Lead Sponsor: Merck Sharp & Dohme LLC

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2004-06-30
• Study First Submitted: 2004-07-02
• Study First Submitted QC: 2004-07-02
• Study First Posted: 2004-07-05
• Primary Completion: 2005-07-20
• Study Completion: 2007-02-02
• Results First Submitted: 2010-11-19
• Results First Submitted QC: 2010-11-19
• Results First Posted: 2010-12-17
• Status Verified: 2017-03
• Last Update Submitted: 2017-03-31
• Last Update Posted: 2017-05-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 701

Inclusion Criteria

• Patients with type 2 diabetes mellitus

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Sitagliptin 100 mg	Sitagliptin (MK0431)	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.
Sitagliptin 100 mg	Metformin	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.
Placebo / Glipizide 5 mg	Placebo/Glipizide 5 mg	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.
Placebo / Glipizide 5 mg	Metformin	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.
Sitagliptin 100 mg	Pioglitazone	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.
Placebo / Glipizide 5 mg	Pioglitazone	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.

Primary Outcome Measures

Name	Time	Method
Change From Baseline in Hemoglobin A1C (A1C) at Week 24	Baseline and Week 24	A1C is measured as a percent. Thus, this change from; baseline reflects the Week 24 A1C percent minus the Week 0 A1C percent.

Secondary Outcome Measures

Name	Time	Method
Change From Baseline in Fasting Plasma Glucose (FPG) at Week 24	Baseline and Week 24	Change from baseline at Week 24 is defined as FPG at; Week 24 minus FPG at Week 0.
Change From Baseline in 2-hour Post-meal Glucose (PMG) at Week 24	Baseline and Week 24	Change from baseline at Week 24 is defined as PMG at Week 24 minus PMG at Week 0.