An Investigational Drug Study in Patients With Type 2 Diabetes Mellitus (MK0431-023)

May 20, 2019 updated by: Merck Sharp & Dohme LLC

A Multicenter, Randomized, Double-Blind Study of MK0431 in Patients With Type 2 Diabetes Mellitus Who Have Inadequate Glycemic Control

The purpose of this study is to determine the safety and effectiveness of an investigational drug in patients with Type 2 Diabetes Mellitus.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

521

Phase

  • Phase 3

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Patients at least 18 years of age and not older than 75 who have a specific type of diabetes called Type 2 Diabetes Mellitus

Exclusion Criteria:

  • Younger than 18 years of age or older than 75
  • Any condition, which in the opinion of the investigator, may not be in the patient's best interest to participate

Study Plan

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

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Sitagliptin 100 mg
Drug: Comparator: sitagliptin 100 mg
sitagliptin 100 mg oral tablet once daily for 54 weeks
Experimental: Sitagliptin 200 mg
Drug: Comparator: sitagliptin 200 mg
sitagliptin 200 mg (2- 100 mg oral tablets) once daily for 54 weeks
Placebo Comparator: Placebo/Pioglitazone
Drug: Comparator: placebo
placebo oral tablet once daily during Phase A (Weeks 0-18)
Drug: Comparator: pioglitazone
pioglitazone 30 mg oral tablet once daily during Phase B (Weeks 18-54)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change From Baseline in A1C at Week 18
Time Frame: Weeks 0-18
Hemoglobin A1C (A1C) is measured as percent. Thus this change from baseline reflects the Week 18 A1C percent minus the Week 0 A1C percent.
Weeks 0-18

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change From Baseline in FPG at Week 18
Time Frame: Weeks 0-18
The change from baseline reflects the Week 18 Fasting Plasma Glucose (FPG) minus the Week 0 FPG.
Weeks 0-18
Change From Baseline in A1C at Week 54
Time Frame: Weeks 0-54
A1C is measured as percent. Thus this change from baseline reflects the Week 54 A1C percent minus the Week 0 A1C percent.
Weeks 0-54
Change From Baseline in FPG at Week 54
Time Frame: Weeks 0-54
The change from baseline reflects the Week 54 FPG minus the Week 0 FPG.
Weeks 0-54

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Merck Sharp & Dohme LLC

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 6, 2004

Primary Completion (Actual)

August 17, 2005

Study Completion (Actual)

April 28, 2006

Study Registration Dates

First Submitted

October 22, 2004

First Submitted That Met QC Criteria

October 22, 2004

First Posted (Estimate)

October 25, 2004

Study Record Updates

Last Update Posted (Actual)

May 30, 2019

Last Update Submitted That Met QC Criteria

May 20, 2019

Last Verified

May 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 0431-023
  • 2004_045

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

http://engagezone.msd.com/doc/ProcedureAccessClinicalTrialData.pdf

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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