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Study MK0767 and Metformin in Type 2 Diabetic Patients (0767-020)

This study has been terminated.
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
NCT00543361
First received: October 5, 2007
Last updated: June 5, 2014
Last verified: June 2014

October 5, 2007
June 5, 2014
May 2003
December 2003   (final data collection date for primary outcome measure)
This study will assess the lipid lowering effectiveness of MK0767 compared to metformin over the course of 52 weeks. [ Time Frame: over the course of 52 weeks ] [ Designated as safety issue: No ]
Not Provided
Complete list of historical versions of study NCT00543361 on ClinicalTrials.gov Archive Site
MK0767 will be safe and well tolerated. [ Time Frame: over the course of 52 weeks ] [ Designated as safety issue: Yes ]
Not Provided
Not Provided
Not Provided
 
Study MK0767 and Metformin in Type 2 Diabetic Patients (0767-020)
A Double-Blind, Randomized, Active-Controlled MK0767 and Metformin Comparator Study in Type 2 Diabetic Patients Inadequately Controlled on Diet and Exercise

The purpose of the study is to assess how MK0767, compared to Metformin, performs in lowering blood glucose levels in patients whose Type II diabetes is not controlled by diet and exercise.

Not Provided
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Diabetes Mellitus, Type 2
  • Drug: MK0767
    Duration of Treatment: 52 Weeks
    Other Name: MK0767
  • Drug: Comparator: placebo (unspecified)
    Duration of Treatment: 52 Weeks
  • Drug: Comparator: metformin
    Duration of Treatment: 52 Weeks
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
382
December 2003
December 2003   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Patients are men and non-pregnant women ages 21 to 78 years
  • Patients either not on antihyperglycemic medications (>8 weeks), or being treated with a single oral antihyperglycemic agent & willing to discontinue therapy for the duration of the study

Exclusion Criteria:

  • Patient has history of type 1 diabetes mellitus and or history of ketoacidosis
  • Patients undergoing surgery within 30 days of Visit 1
  • Patients taking Warfin or Warfin-like anticoagulants
  • Patients on a weight loss program with on-going weight loss or starting an intensive exercise program within 4 weeks of Visit 1/Week 9
Both
21 Years to 78 Years
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT00543361
0767-020, MK0767-020, 2007_627
Not Provided
Merck Sharp & Dohme Corp.
Merck Sharp & Dohme Corp.
Not Provided
Study Director: Medical Monitor Merck Sharp & Dohme Corp.
Merck Sharp & Dohme Corp.
June 2014

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