Completed

MK0431 Monotherapy Safety and Efficacy in Type 2 Diabetes Mellitus Patients

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Study Aim

This phase 3 study aims to evaluate the safety and effectiveness of MK0431 as a standalone treatment in patients with Type 2 Diabetes Mellitus, primarily focusing on the change in A1C levels from the beginning to the 24th week of the treatment.

What is being tested

Sitagliptin (MK0431)

+ Metformin - Rescue

+ Sitagliptin

Drug
Who is being recruted

Diabetes Mellitus+2

+ Diabetes Mellitus, Type 2

+ Endocrine System Diseases

From 18 to 75 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 13, 2026
Sourced from a government-validated database.Claim as a partner

Study start date: June 1, 2004

Actual date on which the first participant was enrolled.

The purpose of this clinical 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 MK0431 Monotherapy in Patients With Type 2 Diabetes Mellitus Who Have Inadequate Glycemic Control 
NCT00087516
Principal SponsorMerck Sharp & Dohme LLC
Last updated: January 13, 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

741 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 75 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 * Patient is not pregnant or breastfeeding * Male or female patient unlikely to conceive * Patient not on an antihyperglycemic drug Exclusion Criteria: * Patient has history of type 1 diabetes mellitus * Patient has history of ketoacidosis * Patient requires insulin within 8 weeks prior to start of study * Patient on weight loss program and is not in maintenance phase * Patient taking weight loss medication within 8 weeks prior to start of study * Patient on or likely to require = 14 days or repeated courses of corticosteroids * Patient taking immunosuppressive/immunomodulating medication * Patient taking digoxin or other cardiac medication * Patient has undergone surgical general anesthesia within 30 days prior to start of study * Patient taking investigational drug within 8 weeks prior to start of study * Patient is diagnosed with liver disease * Patient has chronic myopathy, progressive neurological/neuromuscular disorder * Patient has with severe cardiac conditions within the last 6 months * Patient is Human immunodeficiency virus (HIV) positive * Patient has hematological disorder * Patient has history of malignancy * Patient has history of alcohol or drug abuse within the past 3 years

Study Plan

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

4 intervention groups are designated in this study

50% chance of being blinded to the placebo group

Treatment Groups

Group I

Active Comparator
Phase A and B: Oral tablets of sitagliptin 100 mg Once a Day (q.d )

Group II

Active Comparator
Phase A and B: Oral tablets of sitagliptin 200 mg q.d

Group III

Placebo
Phase A: Oral tablets of placebo matching sitagliptin 100 mg q.d. Phase B: Oral tablets of sitagliptin 100 mg q.d.

Group IV

Placebo
Phase A: Oral tablets of placebo matching sitagliptin 200 mg q.d. Phase B: Oral tablets of sitagliptin 200 mg q.d.

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