Study MK0767 and Metformin in Type 2 Diabetic Patients - Full Text View

Sponsored by:	Merck
Information provided by:	Merck
ClinicalTrials.gov Identifier:	NCT00543361

Purpose

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	Intervention	Phase
Diabetes Mellitus, Type 2	Drug: MK0767 Drug: Comparator: placebo (unspecified) Drug: Comparator: metformin	Phase III

MedlinePlus related topics: Diabetes Exercise and Physical Fitness

Drug Information available for: Metformin Metformin hydrochloride

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Investigator), Active Control, Single Group Assignment, Safety/Efficacy Study
Official Title:	A Double-Blind, Randomized, Active-Controlled MK0767 and Metformin Comparator Study in Type 2 Diabetic Patients Inadequately Controlled on Diet and Exercise

Further study details as provided by Merck:

Primary Outcome Measures:

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 ]

Secondary Outcome Measures:

MK0767 will be safe and well tolerated. [ Time Frame: over the course of 52 weeks ] [ Designated as safety issue: Yes ]

Enrollment:	1000
Study Start Date:	February 2003
Study Completion Date:	March 2005
Primary Completion Date:	March 2005 (Final data collection date for primary outcome measure)

Intervention Details:

Duration of Treatment: 52 Weeks

Eligibility

Ages Eligible for Study:	21 Years to 78 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00543361

Sponsors and Collaborators

Merck

Investigators

Study Director:

Medical Monitor

Merck

More Information

Responsible Party:	Merck & Co., Inc. ( Executive Vice President, Clinical and Quantitative Sciences )
Study ID Numbers:	2007_627, MK0767-020
Study First Received:	October 5, 2007
Last Updated:	May 15, 2008
ClinicalTrials.gov Identifier:	NCT00543361
Health Authority:	United States: Food and Drug Administration

Study placed in the following topic categories:

Metabolic Diseases
Metformin
Diabetes Mellitus, Type 2
Diabetes Mellitus

Endocrine System Diseases
Endocrinopathy
Metabolic disorder
Glucose Metabolism Disorders

Additional relevant MeSH terms:

Hypoglycemic Agents
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 15, 2009