MK0767 in Type 2 Diabetes (0767-012)

This study has been terminated.
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
NCT00543556
First received: October 5, 2007
Last updated: June 5, 2014
Last verified: June 2014
  Purpose

This is a clinical trial in patients with Type 2 Diabetes to test the safety of MK0767. This study will also see how effective MK0767 is in lowering markers of glucose metabolism and improving the lipid profile and non-HDL cholesterol when compared with placebo and pioglitazone.


Condition Intervention Phase
Type 2 Diabetes Mellitus
Drug: MK0767
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment

Resource links provided by NLM:


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

Enrollment: 514
Study Start Date: October 2001
Study Completion Date: November 2003
Primary Completion Date: November 2003 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   21 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Type 2 Diabetes Mellitus patients between the ages of 21 and 75 inclusive
  • Patient is willing to discontinue current therapy for the duration of the study
  • Patient is not a heavy drinker

Exclusion Criteria:

  • Patient has a history of Type 1 diabetes and/or ketoacidosis
  • Patient has severe diabetic retinopathy, or nephropathy, or neuropath
  • Patient has has anti-hyperglycemic therapy including insulin, or rosiglitazone and pioglitazone or 2 or more oral agents in combination within 8 weeks prior to visit 1
  • Patient has a history of, allergy to, intolerance or hypersensitive to troglitazone, rosiglitazone, or pioglitazone including history of elevated liver function test, jaundice, or hepatotoxicity associated with these treatments
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00543556

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

No publications provided

Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT00543556     History of Changes
Other Study ID Numbers: 0767-012, 2007_640
Study First Received: October 5, 2007
Last Updated: June 5, 2014
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases

ClinicalTrials.gov processed this record on August 28, 2014