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

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. Identifier: NCT00543361
Recruitment Status : Terminated
First Posted : October 15, 2007
Last Update Posted : June 12, 2015
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Diabetes Mellitus, Type 2 Drug: MK0767 Drug: Comparator: placebo (unspecified) Drug: Comparator: metformin Phase 3

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 382 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: A Double-Blind, Randomized, Active-Controlled MK0767 and Metformin Comparator Study in Type 2 Diabetic Patients Inadequately Controlled on Diet and Exercise
Study Start Date : May 2003
Actual Primary Completion Date : December 2003
Actual Study Completion Date : December 2003

Resource links provided by the National Library of Medicine

Intervention Details:
  • Drug: MK0767
    Duration of Treatment: 52 Weeks
  • Drug: Comparator: placebo (unspecified)
    Duration of Treatment: 52 Weeks
  • Drug: Comparator: metformin
    Duration of Treatment: 52 Weeks

Primary Outcome Measures :
  1. 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 ]

Secondary Outcome Measures :
  1. MK0767 will be safe and well tolerated. [ Time Frame: over the course of 52 weeks ]

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:   21 Years to 78 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

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 identifier (NCT number): NCT00543361

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

Responsible Party: Merck Sharp & Dohme Corp. Identifier: NCT00543361     History of Changes
Other Study ID Numbers: 0767-020
First Posted: October 15, 2007    Key Record Dates
Last Update Posted: June 12, 2015
Last Verified: June 2015

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Hypoglycemic Agents
Physiological Effects of Drugs