Sitagliptin Comparative Study in Patients With Type 2 Diabetes (0431-049)

April 5, 2017 updated by: Merck Sharp & Dohme LLC

A Multicenter, Double-Blind, Randomized Study to Evaluate the Safety and Efficacy of Sitagliptin Compared With Metformin in Patients With Type 2 Diabetes Mellitus With Inadequate Glycemic Control

A study to evaluate the efficacy and safety of sitagliptin in comparison to a commonly used medication in patients with type 2 diabetes

Study Overview

Study Type

Interventional

Enrollment (Actual)

1050

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 78 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

General Inclusion Criteria:

  • Patient has type 2 diabetes mellitus (T2DM)
  • Patient is inadequately controlled and not on treatment with insulin or oral antihyperglycemic therapy

General Exclusion Criteria:

  • Patient has a history of type 1 diabetes mellitus or history of ketoacidosis
  • Patient was on antihyperglycemic therapy (insulin or oral) within the prior 4 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: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 1
Drug
(1) sitagliptin 100mg tablet once daily (q.d.) for a 24-wk treatment period
Other Names:
  • MK0431
Active Comparator: 2
Active comparator
(4) Metformin 500mg tablets once daily (q.d.) for a 24-wk treatment period.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change From Baseline in Hemoglobin A1c (HbA1c) at Week 24
Time Frame: Baseline and 24 weeks
HbA1c is measured as a percent. Thus, this change from baseline reflects the Week 24 HbA1c percent minus the Week 0 HbA1c percent.
Baseline and 24 weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
Number of Patients Who Reported 1 or More Episodes of the Adverse Experience of Diarrhea
Time Frame: Baseline to Week 24
Baseline to Week 24
Number of Patients Who Reported 1 or More Episodes of the Adverse Experience of Nausea
Time Frame: Baseline to Week 24
Baseline to Week 24
Number of Patients Who Reported 1 or More Episodes of the Adverse Experience of Abdominal Pain
Time Frame: Baseline to Week 24
Baseline to Week 24
Number of Patients Who Reported 1 or More Episodes of the Adverse Experience of Vomiting
Time Frame: Baseline to Week 24
Baseline to Week 24

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

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.

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)

March 1, 2007

Primary Completion (Actual)

July 25, 2008

Study Completion (Actual)

July 25, 2008

Study Registration Dates

First Submitted

March 19, 2007

First Submitted That Met QC Criteria

March 19, 2007

First Posted (Estimate)

March 21, 2007

Study Record Updates

Last Update Posted (Actual)

May 11, 2017

Last Update Submitted That Met QC Criteria

April 5, 2017

Last Verified

April 1, 2017

More Information

Terms related to this study

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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