Sulfonylurea Add-on Study in Patients With Type 2 Diabetes Mellitus (0431-035)

June 4, 2015 updated by: Merck Sharp & Dohme LLC

A Multicenter, Randomized, Double Blind, Placebo-Controlled 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 Glimepiride Alone or in Combination With Metformin

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

441

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 with Type 2 Diabetes Mellitus with inadequate glycemic control

Exclusion Criteria:

  • Patients with Type 1 Diabetes Mellitus

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: Crossover Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Sitagliptin
Sitagliptin 10 mg tablet daily for 54 weeks
Drug: Comparator: Sitagliptin
sitagliptin 10 mg tablet, once daily for 54 weeks
Placebo Comparator: Placebo/ Pioglitazone
Placebo tablet daily for 24 weeks followed by Pioglitazone tablet daily for 30 weeks
Drug: Comparator: Placebo
Placebo oral tablet once daily for 24 weeks
Drug: Comparator: Pioglitazone
Pioglitazone 30 mg tablet once daily for 30 weeks

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change From Baseline in A1C at Week 24
Time Frame: Baseline and 24 Weeks
Hemoglobin A1C (A1C) is measured as percent. Thus this change from baseline reflects the Week 24 A1C percent minus the Week 0 A1C percent.
Baseline and 24 Weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change From Baseline in FPG at Week 24
Time Frame: Baseline and 24 Weeks
The change from baseline is the Week 24 Fasting Plasma Glucose (FPG) minus the Week 0 FPG.
Baseline and 24 Weeks

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

March 1, 2005

Primary Completion (Actual)

June 1, 2006

Study Completion (Actual)

January 1, 2007

Study Registration Dates

First Submitted

March 29, 2005

First Submitted That Met QC Criteria

March 29, 2005

First Posted (Estimate)

March 30, 2005

Study Record Updates

Last Update Posted (Estimate)

July 1, 2015

Last Update Submitted That Met QC Criteria

June 4, 2015

Last Verified

June 1, 2015

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 0431-035
  • 2005_009

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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