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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 Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
NCT00868790
First received: March 24, 2009
Last updated: June 7, 2012
Last verified: June 2012
  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:


Further study details as provided by Merck Sharp & Dohme Corp.:

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Sponsors and Collaborators
Merck Sharp & Dohme Corp.
Investigators
Study Director: Medical Monitor Merck Sharp & Dohme Corp.
  More Information

No publications provided

Responsible Party: Merck Sharp & Dohme Corp.
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
Endocrine System Diseases
Glucose Metabolism Disorders
Metabolic Diseases
Metformin
Hypoglycemic Agents
Pharmacologic Actions
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on November 27, 2014