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A Study of the Safety and Efficacy of MK3577 in Patients With Type 2 Diabetes Mellitus (MK-3577-009)(TERMINATED)

This study has been terminated.
(Upon interim analysis, sufficient data was accrued to assess study hypotheses.)
Sponsor:
Information provided by (Responsible Party):
Merck
ClinicalTrials.gov Identifier:
NCT00868790
First received: March 24, 2009
Last updated: June 7, 2012
Last verified: June 2012
History of Changes
  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: Comparator: Placebo to MK3577
Drug: MK3577
Drug: Comparator: metformin
 Phase 2

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

Resource links provided by NLM:

U.S. FDA Resources

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 ]

Enrollment: 118
Study Start Date: March 2009
Study Completion Date: July 2010
Primary Completion Date: July 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: A
Placebo
 Drug: Comparator: Placebo to MK3577
Placebo to MK3577 tablets twice daily for 4 weeks
Experimental: B
MK3577 10 mg QD AM
 Drug: MK3577
MK3577 tablets totaling 10 mg once daily in the morning for 4 weeks.
Other Name: MK3577
Experimental: C
MK3577 6 mg QD PM
 Drug: MK3577
MK3577 tablets totaling 6 mg once daily in the evening for 4 weeks.
Other Name: MK3577
Experimental: D
MK3577 25 mg BID
 Drug: MK3577
MK3577 tablets totaling 25 mg twice daily for 4 weeks.
Other Name: MK3577
Active Comparator: E
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 prescription lipid-modifying drug 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

Sponsors and Collaborators
Merck
Investigators
Study Director: Medical Monitor Merck
  More Information

No publications provided

Responsible Party: Merck
ClinicalTrials.gov Identifier: NCT00868790     History of Changes
Other Study ID Numbers: 2009_564, MK3577-009
Study First Received: March 24, 2009
Last Updated: June 7, 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
 Metformin
Hypoglycemic Agents
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 16, 2013