Sitagliptin Dose Comparison Study in Patients With Type 2 Diabetes (MK-0431-077)(COMPLETED)

April 7, 2017 updated by: Merck Sharp & Dohme LLC

A Phase 1b, Multicenter, Double-Blind, Randomized, Placebo-Controlled, Crossover Clinical Trial of Sitagliptin 100 mg and Sitagliptin 200 mg in Patients With Type 2 Diabetes Mellitus Who Have Inadequate Glycemic Control on Diet and Exercise

A study to assess the safety and efficacy of sitagliptin 100mg compared to sitagliptin 200mg in patients with type 2 diabetes.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

103

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 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Patient has Type 2 Diabetes
  • Patient is between the ages of 30-65 years
  • Patient is not on an antihyperglycemic agent (AHA) (glycosylated hemoglobin [A1C] 7-10% ), or is on oral single AHA or low-dose combination therapy (A1C 6.5-9.5%).

Exclusion Criteria:

  • Patient has Type 1 Diabetes
  • Patient has been treated with sitagliptin, vildagliptin, or other similar drugs or has been treated with exenatide in the past 3 months
  • Patient has taken insulin within the past 3 months

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
Placebo Comparator: 3
Placebo
Drug: Comparator: Placebo
sitagliptin 100 mg & 200 mg matching Placebo tablets q.d. (once daily) for 7 days.
Experimental: 1
sitagliptin 100 mg
Drug: sitagliptin phosphate
sitagliptin 100 mg tablets q.d. (once daily) for 7 days.
Other Names:
  • MK0431
Drug: sitagliptin phosphate
sitagliptin 200 mg tablets q.d. (once daily) for 7 days.
Other Names:
  • MK0431
Experimental: 2
sitagliptin 200 mg
Drug: sitagliptin phosphate
sitagliptin 100 mg tablets q.d. (once daily) for 7 days.
Other Names:
  • MK0431
Drug: sitagliptin phosphate
sitagliptin 200 mg tablets q.d. (once daily) for 7 days.
Other Names:
  • MK0431

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
24-hour Weighted Mean Glucose (WMG)
Time Frame: Day 7 of Treatment Period I. Due to a carry-over effect that was observed between treatment periods, efficacy results are presented from Treatment Period I only.
The 24-hour WMG was calculated as the area under the 24-hour glucose curve (AUC(0-24 hr)) divided by 24 using linear trapezoidal method.
Day 7 of Treatment Period I. Due to a carry-over effect that was observed between treatment periods, efficacy results are presented from Treatment Period I only.

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)

August 24, 2007

Primary Completion (Actual)

June 17, 2008

Study Completion (Actual)

July 1, 2008

Study Registration Dates

First Submitted

October 5, 2007

First Submitted That Met QC Criteria

October 5, 2007

First Posted (Estimate)

October 10, 2007

Study Record Updates

Last Update Posted (Actual)

May 12, 2017

Last Update Submitted That Met QC Criteria

April 7, 2017

Last Verified

April 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 0431-077
  • 2007_533

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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