Clinical Study on Sitagliptin for Assessment of Glucose-lowering Effects (0431-045)

March 31, 2017 updated by: Merck Sharp & Dohme LLC

Phase II Study on Sitagliptin -Assessment of Glucose-lowering Effects

A clinical study determines the safety and efficacy of sitagliptin (MK0431) in patients with Type 2 diabetes mellitus who have inadequate glycemic control on diet/exercise therapy

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

80

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 69 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Patients Have Type 2 Diabetes Mellitus On Diet/Exercise Therapy

Exclusion Criteria:

  • Patients Have 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
Drug: Comparator: Placebo
Placebo tablet, QD, taken orally for 4 weeks
Experimental: 2
Sitagliptin 100 mg
Drug: sitagliptin phosphate
100 mg once daily (QD), taken orally for 4 weeks
Other Names:
  • MK0431
Experimental: 3
Sitagliptin 50 mg
Drug: Comparator: Sitagliptin
50 mg twice daily (BID), taken orally for 4 weeks
Other Names:
  • MK0431

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change From Baseline in 24-hour Weighted Mean Plasma Glucose
Time Frame: Baseline and Week 4
Change from baseline at Week 4 is defined as 24-hour weighted mean glucose (24hr-WMG) at Week 4 minus 24hr-WMG at Week 0.
Baseline and Week 4

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change From Baseline in Plasma Glucose
Time Frame: Baseline and Week 4
Change from baseline at Week 4 is defined as fasting plasma glucose at Week 4 minus fasting plasma glucose at Week 0.
Baseline and Week 4

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)

July 3, 2005

Primary Completion (Actual)

February 13, 2006

Study Completion (Actual)

February 13, 2006

Study Registration Dates

First Submitted

September 22, 2008

First Submitted That Met QC Criteria

September 22, 2008

First Posted (Estimate)

September 23, 2008

Study Record Updates

Last Update Posted (Actual)

May 5, 2017

Last Update Submitted That Met QC Criteria

March 31, 2017

Last Verified

March 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 0431-045
  • MK0431-045
  • 2008_026

Plan for Individual participant data (IPD)

Study Data/Documents

  1. CSR Synopsis

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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