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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
NCT00482729
First received: May 31, 2007
Last updated: May 11, 2017
Last verified: May 2017
May 31, 2007
May 11, 2017
June 19, 2007
November 3, 2008   (Final data collection date for primary outcome measure)
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.
Not Provided
Complete list of historical versions of study NCT00482729 on ClinicalTrials.gov Archive Site
  • 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.
Not Provided
  • 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 ]
Not Provided
 
MK0431A Comparative Study in Patients With Type 2 Diabetes (0431A-079)(COMPLETED)
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.
Not Provided
Interventional
Phase 3
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Type 2 Diabetes Mellitus
  • 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
  • Experimental: 1
    Arm 1: drug
    Intervention: Drug: sitagliptin phosphate (+) metformin hydrochloride
  • Active Comparator: 2
    Arm 2: active comparator
    Intervention: Drug: metformin

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
1246
April 27, 2009
November 3, 2008   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
18 Years to 78 Years   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
Puerto Rico,   United States
 
NCT00482729
0431A-079
MK0431A-079
2007_548
Not Provided
Not Provided
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

Merck Sharp & Dohme Corp.
Merck Sharp & Dohme Corp.
Not Provided
Study Director: Medical Monitor Merck Sharp & Dohme Corp.
Merck Sharp & Dohme Corp.
May 2017

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