A Study of an Investigational Drug Sitagliptin for Type 2 Diabetes Mellitus (0431-044)

May 20, 2015 updated by: Merck Sharp & Dohme LLC

Sitagliptin (MK0431) Late Phase II Double-Blind Dose-Response Study - Type 2 Diabetes Mellitus

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

363

Phase

  • Phase 2

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

20 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

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: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: 1
Placebo QD 12-week
Drug: Comparator: placebo (unspecified)
placebo QD 12-weeks
Experimental: 2
25 mg QD 12-week
Drug: sitagliptin phosphate
sitagliptin phosphate 25 mg, 50 mg, 100 mg QD, or 200 mg QD 12-weeks.
Other Names:
  • MK0431
Experimental: 3
50 mg QD 12-week
Drug: sitagliptin phosphate
sitagliptin phosphate 25 mg, 50 mg, 100 mg QD, or 200 mg QD 12-weeks.
Other Names:
  • MK0431
Experimental: 4
100 mg QD 12-week
Drug: sitagliptin phosphate
sitagliptin phosphate 25 mg, 50 mg, 100 mg QD, or 200 mg QD 12-weeks.
Other Names:
  • MK0431
Experimental: 5
200 mg QD 12-week
Drug: sitagliptin phosphate
sitagliptin phosphate 25 mg, 50 mg, 100 mg QD, or 200 mg QD 12-weeks.
Other Names:
  • MK0431

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change From Baseline in HbA1c at Week 12
Time Frame: Baseline and Week 12
HbA1c is measured as a percent. Thus, this change from baseline reflects the Week 12 HbA1c percent minus the Week 0 HbA1c percent.
Baseline and Week 12

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change From Baseline in Glycosylated Albumin at Week 12
Time Frame: Baseline and Week 12
Change from baseline at Week 12 is defined as Week 12 minus Week 0.
Baseline and Week 12
Change From Baseline in Fasting Plasma Glucose at Week 12
Time Frame: Baseline and Week 12
Change from baseline at Week 12 is defined as Week 12 minus Week 0.
Baseline and Week 12

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

July 1, 2005

Primary Completion (Actual)

March 1, 2006

Study Completion (Actual)

March 1, 2006

Study Registration Dates

First Submitted

August 3, 2005

First Submitted That Met QC Criteria

August 4, 2005

First Posted (Estimate)

August 5, 2005

Study Record Updates

Last Update Posted (Estimate)

June 15, 2015

Last Update Submitted That Met QC Criteria

May 20, 2015

Last Verified

May 1, 2015

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 0431-044
  • MK0431-044
  • 2005_037

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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