MK0431A Comparative Study in Patients With Type 2 Diabetes (0431A-079)(COMPLETED)

May 11, 2017 updated by: Merck Sharp & Dohme LLC

A Randomized, Double-Blind, Active-Comparator Controlled, Clinical Trial to Study the Efficacy and Safety of MK0431A for the Treatment of Patients With Type 2 Diabetes Mellitus (T2DM)

The purpose of this study is to investigate the efficacy and safety of an investigational treatment for type 2 diabetes mellitus.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

1246

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

Inclusion Criteria:

  • Patient has type 2 diabetes mellitus
  • Patient is greater than or equal to 18 and less than or equal to 78 years of age on the day of signing the consent
  • Patient has Hb1Ac greater than or equal to 7.5% and is appropriate for oral therapy
  • Patient has not been on any antihyperglycemic agent (AHA) in the last 4 months
  • Patient is a male, or a female who is unlikely to conceive

Exclusion Criteria:

  • Patient has type 1 diabetes mellitus or history of ketoacidosis

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
  • Masking: DOUBLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: 1
Arm 1: drug
Drug: sitagliptin phosphate (+) metformin hydrochloride
sitagliptin/Metformin HCl 50/500 mg tablet bid, titrating up to sitagliptin/Metformin HCl 50/1000 mg tablet over 4 weeks; for a 44-wk treatment period.
Other Names:
  • MK0431A
  • Janumet™
ACTIVE_COMPARATOR: 2
Arm 2: active comparator
Drug: metformin
metformin 500 mg tablet bid, titrating up to 1000 mg tablets bid for a 44-wk treatment period

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change From Baseline in Hemoglobin A1c (A1C) at Week 18
Time Frame: Baseline and Week 18
A1C is measured as percent. Thus, this change from baseline reflects the Week 18 A1C percent minus the Week 0 A1C percent.
Baseline and Week 18

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of Patients With A1C < 7.0% at Week 18
Time Frame: Week 18
Week 18
Change From Baseline in Fasting Plasma Glucose (FPG) at Week 18
Time Frame: Baseline and Week 18
FPG is measured as mg/dL. Thus, this change from baseline reflects the Week 18 FPG mg/dL minus the Week 0 FPG mg/dL.
Baseline and Week 18

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change From Baseline in A1C at Week 44
Time Frame: Baseline and Week 44
A1C is measured as percent. Thus, this change from baseline reflects the Week 44 A1C percent minus the Week 0 A1C percent.
Baseline and Week 44
Number of Patients With A1C < 7.0% at Week 44
Time Frame: Week 44
Week 44

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)

June 19, 2007

Primary Completion (ACTUAL)

November 3, 2008

Study Completion (ACTUAL)

April 27, 2009

Study Registration Dates

First Submitted

May 31, 2007

First Submitted That Met QC Criteria

June 1, 2007

First Posted (ESTIMATE)

June 5, 2007

Study Record Updates

Last Update Posted (ACTUAL)

June 9, 2017

Last Update Submitted That Met QC Criteria

May 11, 2017

Last Verified

May 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 0431A-079
  • MK0431A-079
  • 2007_548

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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