A Study to Test MK0941 in Patients With Type 2 Diabetes Mellitus With Inadequate Glycemic Control on Metformin (0941-017)(COMPLETED) - Full Text View

Sponsor:	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

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

Resource links provided by NLM:

Genetics Home Reference related topics: 6q24-related transient neonatal diabetes mellitus

MedlinePlus related topics: Diabetes Diabetes Type 2

Drug Information available for: Glimepiride Metformin Metformin hydrochloride

U.S. FDA Resources

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 ]

Enrollment:	143
Study Start Date:	January 2009
Study Completion Date:	February 2010
Primary Completion Date:	February 2010 (Final data collection date for primary outcome measure)

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

Eligibility

Ages Eligible for Study:	18 Years to 70 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Patient has type 2 diabetes mellitus
Between the ages of 18 and 70

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

Sponsors and Collaborators

Merck

Investigators

Study Director:

Medical Monitor

Merck

More Information

No publications provided

Responsible Party:	Executive Vice President, Clinical and Quantitative Sciences, Merck & Co., Inc.
ClinicalTrials.gov Identifier:	NCT00792935 History of Changes
Other Study ID Numbers:	2008_589, MK0941-017
Study First Received:	November 14, 2008
Last Updated:	January 4, 2012
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
Glimepiride
Metformin
Hypoglycemic Agents

Physiological Effects of Drugs
Pharmacologic Actions
Immunosuppressive Agents
Immunologic Factors
Anti-Arrhythmia Agents
Cardiovascular Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on February 09, 2012