Study to Assess the Efficacy and Safety of Sitagliptin Added to the Regimen of Patients With Type 2 Diabetes Mellitus With Inadequate Glycemic Control on Metformin (0431-189)

April 28, 2017 updated by: Merck Sharp & Dohme LLC

A Multicenter, Randomized, Open-label Study to Assess the Efficacy and Safety of Sitagliptin Added to the Regimen of Patients With T2 DM With Inadequate Glycemic Control on Metformin

After 24 weeks of treatment, to assess the A1C-lowering efficacy of sitagliptin 100 mg once daily added to the regimen of patients with inadequate glycemic control on metformin monotherapy

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

68

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

30 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 30-78 Years Of Age On The Day Of Signing Informed Consent
  • Patient Is Currently On Metformin Therapy (1500 Mg/Day)
  • Patient Is A Male Or A Female Who Is Unlikely To Conceive, As Indicated By At Least One Yes Answer To The Following Questions: A) Patient Is A Male. B) Patient Is A Surgically Sterilized Female. C) Patient Is A Postmenopausal Female 45 Years Of Age With >2 Years Since Last Menses. D) Patient Is A Non-Sterilized Premenopausal Female And Agrees To Use An Adequate Method Of Contraception To Prevent Pregnancy Throughout The Study Starting With Visit 1 And For 14 Days After The Last Dose Of Study Medication
  • Patient Understands The Study Procedures, The Alternative Treatments Available, The Risks Involved In The Study And Voluntarily Agrees To Participate By Giving Written Informed Consent
  • Patient Has An A1c of 6.5 % - 11.0%

Exclusion Criteria:

  • Patient Has A History Of 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: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: 1
sitagliptin + metformin
Drug: sitagliptin phosphate
sitagliptin 100 mg Once a day (QD) for 24 weeks
Other Names:
  • sitagliptin
Drug: Comparator: metformin
metformin 850 mg Twice a day (BID) for 24 weeks
Other Names:
  • metformin
Drug: Comparator: metformin
metformin 500 mg Three times a day (TID) to 850 mg Twice a day (BID), for 24 weeks
Other Names:
  • metformin
ACTIVE_COMPARATOR: 2
metformin + any other oral antidiabetic drug
Drug: Comparator: metformin
metformin 850 mg Twice a day (BID) for 24 weeks
Other Names:
  • metformin
Drug: Comparator: metformin
metformin 500 mg Three times a day (TID) to 850 mg Twice a day (BID), for 24 weeks
Other Names:
  • metformin
Drug: Comparator: Antidiabetic Standard of Care
Patient can take any oral antidiabetic drug (other than metformin)
ACTIVE_COMPARATOR: 3
metformin
Drug: Comparator: metformin
metformin 850 mg Twice a day (BID) for 24 weeks
Other Names:
  • metformin
Drug: Comparator: metformin
metformin 500 mg Three times a day (TID) to 850 mg Twice a day (BID), for 24 weeks
Other Names:
  • metformin

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change From Baseline in Glycosylated Hemoglobin A1C (A1C) at Week 24
Time Frame: Baseline and 24 weeks
Week 24 A1C minus baseline (Week 0) A1C. The unit for A1C is "percent". Thus, this measure represents a difference of percent values.
Baseline and 24 weeks

Collaborators and Investigators

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

Sponsor

Merck Sharp & Dohme LLC

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 1, 2007

Primary Completion (ACTUAL)

June 27, 2008

Study Completion (ACTUAL)

June 27, 2008

Study Registration Dates

First Submitted

April 1, 2009

First Submitted That Met QC Criteria

April 2, 2009

First Posted (ESTIMATE)

April 3, 2009

Study Record Updates

Last Update Posted (ACTUAL)

May 30, 2017

Last Update Submitted That Met QC Criteria

April 28, 2017

Last Verified

April 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 0431-189
  • 2009_571

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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