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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00482729
First Posted: June 5, 2007
Last Update Posted: June 9, 2017
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.
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
  Purpose
The purpose of this study is to investigate the efficacy and safety of an investigational treatment for type 2 diabetes mellitus.

Condition Intervention Phase
Type 2 Diabetes Mellitus Drug: sitagliptin phosphate (+) metformin hydrochloride Drug: metformin Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: 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)

Resource links provided by NLM:


Further study details as provided by Merck Sharp & Dohme Corp.:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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.


Other Outcome Measures:
  • 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 ]

Enrollment: 1246
Actual Study Start Date: June 19, 2007
Study Completion Date: April 27, 2009
Primary Completion Date: November 3, 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 78 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00482729


Sponsors and Collaborators
Merck Sharp & Dohme Corp.
Investigators
Study Director: Medical Monitor Merck Sharp & Dohme Corp.
  More Information

Additional Information:
Publications:
Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT00482729     History of Changes
Other Study ID Numbers: 0431A-079
MK0431A-079
2007_548
First Submitted: May 31, 2007
First Posted: June 5, 2007
Results First Submitted: December 9, 2009
Results First Posted: March 15, 2010
Last Update Posted: June 9, 2017
Last Verified: May 2017
Individual Participant Data (IPD) Sharing Statement:
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


Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Metformin
Sitagliptin Phosphate
Hypoglycemic Agents
Physiological Effects of Drugs
Incretins
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Dipeptidyl-Peptidase IV Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action