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

Overview[ - collapse ][ - ]

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.
ConditionType 2 Diabetes Mellitus
InterventionDrug: Comparator: Placebo to MK3577
Drug: MK3577
Drug: Comparator: metformin
Drug: MK3577
Drug: MK3577
PhasePhase 2
SponsorMerck Sharp & Dohme Corp.
Responsible PartyMerck Sharp & Dohme Corp.
ClinicalTrials.gov IdentifierNCT00868790
First ReceivedMarch 24, 2009
Last UpdatedJune 7, 2012
Last verifiedJune 2012

Tracking Information[ + expand ][ + ]

First Received DateMarch 24, 2009
Last Updated DateJune 7, 2012
Start DateMarch 2009
Estimated Primary Completion DateJuly 2010
Current Primary Outcome Measures24-hour weighted mean glucose-lowering efficacy of MK3577 compared to placebo [Time Frame: 4 weeks] [Designated as safety issue: No]
Current Secondary Outcome MeasuresFasting glucose levels after evening administration of MK3577 or placebo [Time Frame: 4 weeks] [Designated as safety issue: No]

Descriptive Information[ + expand ][ + ]

Brief TitleA Study of the Safety and Efficacy of MK3577 in Patients With Type 2 Diabetes Mellitus (MK-3577-009)(TERMINATED)
Official TitleA 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
Brief Summary
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.
Detailed DescriptionNot Provided
Study TypeInterventional
Study PhasePhase 2
Study DesignAllocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
ConditionType 2 Diabetes Mellitus
InterventionDrug: Comparator: Placebo to MK3577
Placebo to MK3577 tablets twice daily for 4 weeks
Drug: MK3577
MK3577 tablets totaling 10 mg once daily in the morning for 4 weeks.
Other Names:
MK3577Drug: Comparator: metformin
Metformin tablets 1000 mg twice daily for 4 weeks.
Drug: MK3577
MK3577 tablets totaling 6 mg once daily in the evening for 4 weeks.
Other Names:
MK3577Drug: MK3577
MK3577 tablets totaling 25 mg twice daily for 4 weeks.
Other Names:
MK3577
Study Arm (s)
  • Placebo Comparator: A
    Placebo
  • Experimental: B
    MK3577 10 mg QD AM
  • Experimental: C
    MK3577 6 mg QD PM
  • Experimental: D
    MK3577 25 mg BID
  • Active Comparator: E
    Metformin 1000 mg BID

Recruitment Information[ + expand ][ + ]

Recruitment StatusTerminated
Estimated Enrollment118
Estimated Completion DateJuly 2010
Estimated Primary Completion DateJuly 2010
Eligibility 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
GenderBoth
Ages18 Years
Accepts Healthy VolunteersNo
ContactsNot Provided
Location CountriesNot Provided

Administrative Information[ + expand ][ + ]

NCT Number NCT00868790
Other Study ID Numbers2009_564
Has Data Monitoring CommitteeYes
Information Provided ByMerck Sharp & Dohme Corp.
Study SponsorMerck Sharp & Dohme Corp.
CollaboratorsNot Provided
Investigators Study Director: Medical Monitor Merck Sharp & Dohme Corp.
Verification DateJune 2012