Effect of SCH 497079 on Metabolic Parameters and Influence of Race/Ethnic Origin on Therapeutic Response (Study P05338AM1)(COMPLETED)

Overview[ - collapse ][ - ]

Purpose The purpose of this study is to evaluate the effect of SCH 497079 on metabolic parameters and to determine the influence of race/ethnic origin on therapeutic response.
ConditionType 2 Diabetes Mellitus
InterventionDrug: SCH 497079
Drug: Placebo
Drug: Metformin extended release
PhasePhase 1
SponsorMerck Sharp & Dohme Corp.
Responsible PartyMerck Sharp & Dohme Corp.
ClinicalTrials.gov IdentifierNCT00673465
First ReceivedMay 5, 2008
Last UpdatedOctober 25, 2013
Last verifiedOctober 2013

Tracking Information[ + expand ][ + ]

First Received DateMay 5, 2008
Last Updated DateOctober 25, 2013
Start DateMay 2008
Estimated Primary Completion DateDecember 2008
Current Primary Outcome Measures24-hour glycemic profile [Time Frame: after 4 weeks of treatment] [Designated as safety issue: No]
Current Secondary Outcome Measures
  • adverse events, vital signs, clinical labs, ecgs [Time Frame: after 4 weeks of treatment] [Designated as safety issue: Yes]
  • pharmacodynamic effects [Time Frame: after 4 weeks of treatment] [Designated as safety issue: No]
  • steady state pharmacokinetics [Time Frame: after 4 weeks of treatment] [Designated as safety issue: No]

Descriptive Information[ + expand ][ + ]

Brief TitleEffect of SCH 497079 on Metabolic Parameters and Influence of Race/Ethnic Origin on Therapeutic Response (Study P05338AM1)(COMPLETED)
Official TitleA Randomized, Placebo-controlled, Three-Way Crossover Study to Evaluate the Effect of SCH 497079 on Metabolic Parameters and to Determine the Influence of Race/Ethnic Origin on Therapeutic Response
Brief Summary
The purpose of this study is to evaluate the effect of SCH 497079 on metabolic parameters
and to determine the influence of race/ethnic origin on therapeutic response.
Detailed DescriptionNot Provided
Study TypeInterventional
Study PhasePhase 1
Study DesignAllocation: Randomized, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
ConditionType 2 Diabetes Mellitus
InterventionDrug: SCH 497079
100 mg, administered orally, once-daily x 28 days
Drug: Placebo
Placebo capsules matching SCH 497079 administered once daily x 28 days
Drug: Metformin extended release
1500 mg, administered orally, once-daily x 28 days
Study Arm (s)
  • Experimental: SCH 497079
  • Placebo Comparator: Placebo
  • Other: Metformin hydrochloride

Recruitment Information[ + expand ][ + ]

Recruitment StatusCompleted
Estimated Enrollment17
Estimated Completion DateDecember 2008
Estimated Primary Completion DateDecember 2008
Eligibility Criteria
Inclusion Criteria:

- >=18 years of age to 65 years of age, of either sex, and having a body mass index
(BMI) between 27 and 35, inclusive (USA subjects)

- Clinical laboratory tests (CBC blood chemistry, and urinalysis) within normal limits
(excluding glucose and other changes usually associated with diabetes eg,
dyslipidemia)

- Type 2 diabetes mellitus

Exclusion Criteria:

- Female subjects who are premenopausal or are not surgically sterilized. Subjects who
are pregnant, intend to become pregnant (within 3 months of ending the study), or are
breast-feeding.

- Subjects who have received insulin therapy within 6 months, prior to Day/Period 1 or
who require thiazide diuretics, beta-blockers and cyclic hormone therapy.
GenderBoth
Ages18 Years
Accepts Healthy VolunteersNo
ContactsNot Provided
Location CountriesNot Provided

Administrative Information[ + expand ][ + ]

NCT Number NCT00673465
Other Study ID NumbersP05338
Has Data Monitoring CommitteeNo
Information Provided ByMerck Sharp & Dohme Corp.
Study SponsorMerck Sharp & Dohme Corp.
CollaboratorsNot Provided
Investigators Not Provided
Verification DateOctober 2013