A Study to Test MK0941 in Patients With Type 2 Diabetes Mellitus With Inadequate Glycemic Control on Metformin - Full Text View

Sponsored by:	Merck
Information provided by:	Merck
ClinicalTrials.gov Identifier:	NCT00792935

Purpose

The purpose of this study is to test the effect of MK0941 as add-on therapy for patients taking metformin for Type II Diabetes.

Condition	Intervention	Phase
Type 2 Diabetes Mellitus	Drug: MK0941 Drug: glimepiride	Phase II

MedlinePlus related topics: Diabetes

Drug Information available for: Metformin Metformin hydrochloride Glimepiride

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Investigator), Active Control, Parallel Assignment, Efficacy Study
Official Title:	A Phase IIa, Multicenter, Double-Blind, Randomized, Active-Controlled, Parallel-Arm Clinical Trial to Study the Efficacy and Safety of MK0941 Compared to Sulfonylurea in Patients With Type 2 Diabetes Mellitus With Inadequate Glycemic Control on Metformin Therapy

Further study details as provided by Merck:

Primary Outcome Measures:

Assess the effect of the addition of MK0941 compared to glimepiride on 24-hour weighted mean glucose when added to metformin [ Time Frame: 6 Weeks ] [ Designated as safety issue: No ]

Estimated Enrollment:	130
Study Start Date:	January 2009
Estimated Study Completion Date:	February 2010
Estimated Primary Completion Date:	February 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental MK0941	Drug: MK0941 MK0941 tablets titrated to maximally effective dose. Treatment period will be 6 weeks.
2: Active Comparator glimepiride	Drug: glimepiride Glimepiride tablets titrated to maximally effective dose. Treatment period of 6 weeks.

Eligibility

Criteria

Inclusion Criteria:

Exclusion Criteria:

Patient has a history of type 1 Diabetes Mellitus or ketoacidosis.
Patient is on a weight loss program and is not in the maintenance phase or is taking weight loss medication.
Patient has had surgery within 30 days of starting the study or has planned major surgery during the study

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00792935

Contacts

Contact: Toll Free Number

1-888-577-8839

Locations

United States, Illinois
Call For Information	Recruiting
Springfield, Illinois, United States, 62704
United States, Washington
Call For Information	Recruiting
Renton, Washington, United States, 98057

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:	2008_589, MK0941-017
Study First Received:	November 14, 2008
Last Updated:	January 9, 2009
ClinicalTrials.gov Identifier:	NCT00792935
Health Authority:	United States: Food and Drug Administration

Study placed in the following topic categories:

Glimepiride
Metabolic Diseases
Metformin
Diabetes Mellitus, Type 2
Diabetes Mellitus

Endocrine System Diseases
Endocrinopathy
Metabolic disorder
Glucose Metabolism Disorders

Additional relevant MeSH terms:

Hypoglycemic Agents
Immunologic Factors
Therapeutic Uses
Physiological Effects of Drugs

Cardiovascular Agents
Anti-Arrhythmia Agents
Immunosuppressive Agents
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 15, 2009