Sitagliptin Mechanism of Action Study in Patients With Type 2 Diabetes Mellitus (0431-059)

April 6, 2017 updated by: Merck Sharp & Dohme LLC

A Randomized, Placebo-Controlled Study to Evaluate the Safety, Efficacy and Mechanism of Action of MK0431/Sitagliptin in Patients With Type 2 Diabetes Mellitus Who Have Inadequate Glycemic Control

A clinical study to determine the safety, efficacy and the way sitagliptin works in patients with Type 2 Diabetes Mellitus who have inadequate glycemic (blood sugar) control.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

57

Phase

  • Phase 1

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

30 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Participant has type 2 diabetes mellitus
  • Males
  • Females who are highly unlikely to become pregnant
  • Participants poorly controlled without taking any, or taking one or two oral antidiabetic medications

Exclusion Criteria:

  • Participant has a history of type 1 diabetes mellitus or history of ketoacidosis
  • Participant required insulin therapy within the prior 8 weeks
  • Participant is on or has been taking TZDs such as Actos® (pioglitazone) or Avandia® (rosiglitazone) within the prior 12 weeks of the screening visit

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: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: sitagliptin
Participants randomized to this arm will be administered sitagliptin 100mg daily, for six weeks.
Drug: Comparator: sitagliptin phosphate
Sitagliptin tablet 100 mg, administered once daily before the morning meal.
Placebo Comparator: Placebo
Participants randomized to this arm will be administered matching placebo, daily for six weeks.
Drug: Comparator: placebo (unspecified)
Matching placebo tablet, administered once daily before the morning meal.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change From Baseline in Glucose 5-Hour Incremental AUC at Week 6
Time Frame: Baseline and Week 6
Participants underwent the 5-hour meal test prior to randomization (baseline) and was repeated at the conclusion of the 6-week double-blind study period. The change from baseline in Glucose 5-Hour Incremental AUC at Week 6 is computed as the difference between the Week 6 measurement and the baseline measurement.
Baseline and Week 6

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)

February 14, 2007

Primary Completion (Actual)

April 28, 2010

Study Completion (Actual)

April 28, 2010

Study Registration Dates

First Submitted

June 23, 2008

First Submitted That Met QC Criteria

June 23, 2008

First Posted (Estimate)

June 24, 2008

Study Record Updates

Last Update Posted (Actual)

May 12, 2017

Last Update Submitted That Met QC Criteria

April 6, 2017

Last Verified

April 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 0431-059
  • 2006_511

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

http://www.merck.com/clinical-trials/pdf/Merck%20Procedure%20on%20Clinical%20Trial%20Data%20Access%20Final_Updated%20July_9_2014.pdf

http://engagezone.msd.com/ds_documentation.php

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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