MK0431A Comparative Study in Patients With Type 2 Diabetes (0431A-079)(COMPLETED)

Overview[ - collapse ][ - ]

Purpose The purpose of this study is to investigate the efficacy and safety of an investigational treatment for type 2 diabetes mellitus.
ConditionType 2 Diabetes Mellitus
InterventionDrug: sitagliptin phosphate (+) metformin hydrochloride
Drug: metformin
PhasePhase 3
SponsorMerck Sharp & Dohme Corp.
Responsible PartyMerck Sharp & Dohme Corp.
ClinicalTrials.gov IdentifierNCT00482729
First ReceivedMay 31, 2007
Last UpdatedNovember 12, 2013
Last verifiedNovember 2013

Tracking Information[ + expand ][ + ]

First Received DateMay 31, 2007
Last Updated DateNovember 12, 2013
Start DateJune 2007
Estimated Primary Completion DateApril 2009
Current Primary Outcome MeasuresChange From Baseline in Hemoglobin A1c (A1C) at Week 18 [Time Frame: Baseline and Week 18] [Designated as safety issue: No]A1C is measured as percent. Thus, this change from baseline reflects the Week 18 A1C percent minus the Week 0 A1C percent.
Current Secondary Outcome Measures
  • Number of Patients With A1C < 7.0% at Week 18 [Time Frame: Week 18] [Designated as safety issue: No]
  • Change From Baseline in Fasting Plasma Glucose (FPG) at Week 18 [Time Frame: Baseline and Week 18] [Designated as safety issue: No]FPG is measured as mg/dL. Thus, this change from baseline reflects the Week 18 FPG mg/dL minus the Week 0 FPG mg/dL.

Descriptive Information[ + expand ][ + ]

Brief TitleMK0431A Comparative Study in Patients With Type 2 Diabetes (0431A-079)(COMPLETED)
Official TitleA Randomized, Double-Blind, Active-Comparator Controlled, Clinical Trial to Study the Efficacy and Safety of MK0431A for the Treatment of Patients With Type 2 Diabetes Mellitus (T2DM)
Brief Summary
The purpose of this study is to investigate the efficacy and safety of an investigational
treatment for type 2 diabetes mellitus.
Detailed DescriptionNot Provided
Study TypeInterventional
Study PhasePhase 3
Study DesignAllocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
ConditionType 2 Diabetes Mellitus
InterventionDrug: sitagliptin phosphate (+) metformin hydrochloride
sitagliptin/Metformin HCl 50/500 mg tablet bid, titrating up to sitagliptin/Metformin HCl 50/1000 mg tablet over 4 weeks; for a 44-wk treatment period.
Other Names:
  • MK0431A
  • Janumet™
Drug: metformin
metformin 500 mg tablet bid, titrating up to 1000 mg tablets bid for a 44-wk treatment period
Other Names:
metformin
Study Arm (s)
  • Experimental: 1
    Arm 1: drug
  • Active Comparator: 2
    Arm 2: active comparator

Recruitment Information[ + expand ][ + ]

Recruitment StatusCompleted
Estimated Enrollment1246
Estimated Completion DateApril 2009
Estimated Primary Completion DateNovember 2008
Eligibility Criteria
Inclusion Criteria:

- Patient has type 2 diabetes mellitus

- Patient is greater than or equal to 18 and less than or equal to 78 years of age on
the day of signing the consent

- Patient has Hb1Ac greater than or equal to 7.5% and is appropriate for oral therapy

- Patient has not been on any antihyperglycemic agent (AHA) in the last 4 months

- Patient is a male, or a female who is unlikely to conceive

Exclusion Criteria:

- Patient has type 1 diabetes mellitus or history of ketoacidosis
GenderBoth
Ages18 Years
Accepts Healthy VolunteersNo
ContactsNot Provided
Location CountriesNot Provided

Administrative Information[ + expand ][ + ]

NCT Number NCT00482729
Other Study ID Numbers0431A-079
Has Data Monitoring CommitteeNot Provided
Information Provided ByMerck Sharp & Dohme Corp.
Study SponsorMerck Sharp & Dohme Corp.
CollaboratorsNot Provided
Investigators Study Director: Medical Monitor Merck Sharp & Dohme Corp.
Verification DateNovember 2013