A Study of the Safety and Efficacy of MK3577 in Patients With Type 2 Diabetes Mellitus - Full Text View

Sponsored by:	Merck
Information provided by:	Merck
ClinicalTrials.gov Identifier:	NCT00868790

Purpose

This study will assess the safety and efficacy of MK3577 when given in the morning, the evening, or twice a day as compared to placebo and to metformin.

Condition	Intervention	Phase
Type 2 Diabetes Mellitus	Drug: MK3577 Drug: Comparator: Placebo Drug: Comparator: metformin	Phase II

MedlinePlus related topics: Diabetes

Drug Information available for: Metformin Metformin hydrochloride

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Investigator), Active Control, Crossover Assignment, Safety/Efficacy Study
Official Title:	A Phase IIa, Multicenter, Randomized, Placebo- and Active-Comparator Controlled, Cross-Over Clinical Trial to Study the Safety and Efficacy of MK3577 in Patients With Type 2 Diabetes Mellitus Who Have Inadequate Glycemic Control

Further study details as provided by Merck:

Primary Outcome Measures:

24-hour weighted mean glucose-lowering efficacy of MK3577 compared to placebo [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Fasting glucose levels after evening administration of MK3577 or placebo [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]

Estimated Enrollment:	276
Study Start Date:	March 2009
Estimated Study Completion Date:	August 2010
Estimated Primary Completion Date:	August 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
A: Placebo Comparator Placebo to MK3577	Drug: Comparator: Placebo Placebo to MK3577 tablets twice daily for 4 weeks.
B: Experimental MK3577 10 mg QD AM	Drug: MK3577 MK3577 tablets totaling 10 mg once daily in the morning for 4 weeks. MK3577 tablets totaling 6 mg once daily in the evening for 4 weeks. MK3577 tablets totaling 25 mg twice daily for 4 weeks.
C: Experimental MK3577 6 mg QD PM	Drug: MK3577 MK3577 tablets totaling 10 mg once daily in the morning for 4 weeks. MK3577 tablets totaling 6 mg once daily in the evening for 4 weeks. MK3577 tablets totaling 25 mg twice daily for 4 weeks.
D: Experimental MK3577 25 mg BID	Drug: MK3577 MK3577 tablets totaling 10 mg once daily in the morning for 4 weeks. MK3577 tablets totaling 6 mg once daily in the evening for 4 weeks. MK3577 tablets totaling 25 mg twice daily for 4 weeks.
E: Active Comparator Metformin 1000 mg BID	Drug: Comparator: metformin Metformin tablets 1000 mg twice daily for 4 weeks.

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
Patient is either not taking antihyperglycemic medications for the last 10 weeks OR is taking a single oral antihyperglycemic medication (but not a PPARg agonist) OR is taking a low-dose combination oral antihyperglycemic medication (not a PPARg agonist) at dose less than or equal to 50% of the maximum dose
Female patient is unable to have children

Exclusion Criteria:

Patient has a history of type 1 diabetes or ketoacidosis
Patient has been treated with a PPARg agonist in the last 12 weeks
Patient has been treated with insulin in the last 12 weeks
Patient has had statin therapy in the last 12 weeks
Patient is on a weight loss program that is not in the maintenance phase or has been treated with a weight loss medication in the last 8 weeks
Patient has a history of coronary artery disease
Patient has had a stroke or transient ischemic attack
Patient has congestive heart failure
Patient is HIV positive
Patient has a history of cancer except certain skin or cervical cancers
Patient is not willing to abstain from alcohol for 48 hours prior to each clinic visit
Patient is breast-feeding
Patient will donate eggs during the study

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00868790

Contacts

Contact: Toll Free Number

1-888-577-8839

Locations

United States, California
Call for Information	Recruiting
Walnut Creek, California, United States, 94598
United States, Idaho
Call for Information	Recruiting
Boise, Idaho, United States, 83704
United States, Kentucky
Call for Information	Recruiting
Paducah, Kentucky, United States, 42003
Call for Information	Recruiting
Louisville, Kentucky, United States, 40213
United States, Louisiana
Call for Information	Recruiting
Baton Rouge, Louisiana, United States, 70809
United States, New Jersey
Call for Information	Recruiting
Berlin, New Jersey, United States, 08009
United States, New York
Call for Information	Recruiting
Freeport, New York, United States, 11520
United States, North Carolina
Call for Information	Recruiting
Winston-Salem, North Carolina, United States, 27103-3914
United States, Utah
Call for Information	Recruiting
Midvale, Utah, United States, 84047
United States, Virginia
Call for Information	Recruiting
Richmond, Virginia, United States, 23294
Malaysia
Merck Sharp & Dohme (I.A.) Corp	Recruiting
Selangor, Malaysia, 46300
Contact: Nazrin Azli 603-77181748

Sponsors and Collaborators

Merck

Investigators

Study Director:

Medical Monitor

Merck

More Information

No publications provided

Responsible Party:	Merck & Co., Inc. ( Executive Vice President, Clinical and Quantitative Sciences )
Study ID Numbers:	2009_564, MK3577-009
Study First Received:	March 24, 2009
Last Updated:	April 30, 2009
ClinicalTrials.gov Identifier:	NCT00868790 History of Changes
Health Authority:	United States: Food and Drug Administration

Study placed in the following topic categories:

Hypoglycemic Agents
Metabolic Diseases
Metformin
Diabetes Mellitus, Type 2
Diabetes Mellitus

Endocrine System Diseases
Endocrinopathy
Glucose Metabolism Disorders
Metabolic Disorder

Additional relevant MeSH terms:

Hypoglycemic Agents
Metabolic Diseases
Physiological Effects of Drugs
Metformin
Diabetes Mellitus, Type 2

Diabetes Mellitus
Endocrine System Diseases
Glucose Metabolism Disorders
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 07, 2009