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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00482729
Recruitment Status : Completed
First Posted : June 5, 2007
Results First Posted : March 15, 2010
Last Update Posted : June 9, 2017
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.

Tracking Information
First Submitted Date  ICMJE May 31, 2007
First Posted Date  ICMJE June 5, 2007
Results First Submitted Date  ICMJE December 9, 2009
Results First Posted Date  ICMJE March 15, 2010
Last Update Posted Date June 9, 2017
Actual Study Start Date  ICMJE June 19, 2007
Actual Primary Completion Date November 3, 2008   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 2, 2010)
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.
Original Primary Outcome Measures  ICMJE Not Provided
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: March 2, 2010)
  • Number of Patients With A1C < 7.0% at Week 18 [ Time Frame: 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.
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures
 (submitted: March 19, 2010)
  • 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.
  • Number of Patients With A1C < 7.0% at Week 44 [ Time Frame: Week 44 ]
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE MK0431A Comparative Study in Patients With Type 2 Diabetes (0431A-079)(COMPLETED)
Official Title  ICMJE 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)
Brief Summary The purpose of this study is to investigate the efficacy and safety of an investigational treatment for type 2 diabetes mellitus.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Type 2 Diabetes Mellitus
Intervention  ICMJE
  • 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™
  • Drug: metformin
    metformin 500 mg tablet bid, titrating up to 1000 mg tablets bid for a 44-wk treatment period
Study Arms  ICMJE
  • Experimental: 1
    Arm 1: drug
    Intervention: Drug: sitagliptin phosphate (+) metformin hydrochloride
  • Active Comparator: 2
    Arm 2: active comparator
    Intervention: Drug: metformin
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: March 2, 2010)
1246
Original Enrollment  ICMJE Not Provided
Actual Study Completion Date  ICMJE April 27, 2009
Actual Primary Completion Date November 3, 2008   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 78 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Not Provided
Removed Location Countries Puerto Rico,   United States
 
Administrative Information
NCT Number  ICMJE NCT00482729
Other Study ID Numbers  ICMJE 0431A-079
MK0431A-079
2007_548
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: Yes
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

Responsible Party Merck Sharp & Dohme Corp.
Study Sponsor  ICMJE Merck Sharp & Dohme Corp.
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Medical Monitor Merck Sharp & Dohme Corp.
PRS Account Merck Sharp & Dohme Corp.
Verification Date May 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP