Completed

MK0431 Addition for Improved Glycemic Control in Type 2 Diabetes Mellitus

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Study Aim

This study aims to evaluate the effectiveness of adding MK0431 to your current treatment for improving blood sugar control, as measured by the change in Hemoglobin A1C levels after 24 weeks, in individuals with Type 2 Diabetes Mellitus.

What is being tested

Sitagliptin (MK0431)

+ Metformin

+ Pioglitazone

Drug
Who is being recruted

Diabetes Mellitus+2

+ Diabetes Mellitus, Type 2

+ Endocrine System Diseases

From 18 to 78 Years
See all eligibility criteria
How is the trial designed

Treatment Study

Placebo-ControlledPhase 3
Interventional
Study Start: June 2004
See protocol details

Summary

Principal SponsorMerck Sharp & Dohme LLC
Last updated: January 14, 2026
Sourced from a government-validated database.Claim as a partner

Study start date: June 30, 2004

Actual date on which the first participant was enrolled.

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

Official TitleA Multicenter, Randomized, Double-Blind Study to Evaluate the Safety and Efficacy of the Addition of MK0431 to Patients With Type 2 Diabetes Mellitus Who Have Inadequate Glycemic Control on Metformin Therapy 
NCT00086515
Principal SponsorMerck Sharp & Dohme LLC
Last updated: January 14, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

701 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

From 18 to 78 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Diabetes MellitusDiabetes Mellitus, Type 2Endocrine System DiseasesMetabolic DiseasesGlucose Metabolism Disorders

Criteria

Inclusion Criteria: * Patients with type 2 diabetes mellitus

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

2 intervention groups are designated in this study

50% chance of being blinded to the placebo group

Treatment Groups

Group I

Experimental
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.

Group II

Placebo
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.

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.
This study has no location dataSave this study to your profile to know when the location data is available. 
CompletedNo study centers