Placebo Controlled Metformin and Sulfonylurea Combination Study in Patients With Type 2 Diabetes (0767-025)

This study has been terminated.
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
NCT00543751
First received: October 5, 2007
Last updated: June 5, 2014
Last verified: June 2014
  Purpose

The purpose of this study is to compare how MK0767 and metformin and sulfonylurea therapy lower blood glucose in patients with inadequate glycemic control This is an early phase trial and some specific protocol information is in progress and not publicly available at this time. (Full information is available to trial participants).


Condition Intervention Phase
Diabetes Mellitus, Type 2
Drug: MK0767
Phase 3

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: 610
Study Start Date: January 2003
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 78 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients with Type 2 diabetes wtih inadequate glycemic control on maximally effective/tolerated metformin and sulfonylurea therapy
  • Non-pregnant females

Exclusion Criteria:

  • Patients with Type 1 Diabetes or history of ketoacidosis
  • Patients who have been treated with insulin or other antihyperglycemic agents
  • Patients with viral hepatitis, active liver or gallbladder disease, history of pancreatitis, heart disease, congestive heart failure, inadequately controlled hypertension, HIV positive, history hematologic disorders or neoplastic disease
  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: NCT00543751

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: NCT00543751     History of Changes
Other Study ID Numbers: 0767-025, 2007_634, MK-0767-025
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 September 18, 2014