Dose-Range Finding Study for MK0893 (0893-008)

Overview[ - collapse ][ - ]

Purpose A study to compare MK0893 to metformin or placebo for patients with Type 2 diabetes (Diabetes Mellitus).
ConditionDiabetes Mellitus, Type 2
InterventionDrug: MK0893
Drug: Metformin
Drug: Placebo to MK0893
Drug: Placebo to Metformin
PhasePhase 2
SponsorMerck Sharp & Dohme Corp.
Responsible PartyMerck Sharp & Dohme Corp.
ClinicalTrials.gov IdentifierNCT00479466
First ReceivedMay 25, 2007
Last UpdatedOctober 15, 2013
Last verifiedOctober 2013

Tracking Information[ + expand ][ + ]

First Received DateMay 25, 2007
Last Updated DateOctober 15, 2013
Start DateJuly 2007
Estimated Primary Completion DateMay 2008
Current Primary Outcome MeasuresChange From Baseline to Week 12 in Fasting Plasma Glucose (FPG) [Time Frame: Week 12] [Designated as safety issue: No]
Current Secondary Outcome Measures
  • Change From Baseline to Week 12 in Hemoglobin A1c (HbA1c) [Time Frame: Week 12] [Designated as safety issue: No]
  • Change From Baseline to Week 12 in 2-Hour Post Prandial Glucose (PPG) [Time Frame: Week 12] [Designated as safety issue: No]

Descriptive Information[ + expand ][ + ]

Brief TitleDose-Range Finding Study for MK0893 (0893-008)
Official TitleA Multicenter, Double-Blind, Randomized, Placebo and Active Comparator Controlled Dose-Range Finding Study of MK0893 in Patients With Type 2 Diabetes Mellitus Who Have Inadequate Glycemic Control
Brief Summary
A study to compare MK0893 to metformin or placebo for patients with Type 2 diabetes
(Diabetes Mellitus).
Detailed DescriptionNot Provided
Study TypeInterventional
Study PhasePhase 2
Study DesignAllocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
ConditionDiabetes Mellitus, Type 2
InterventionDrug: MK0893
MK0893 taken orally once daily; 20 mg and 40 mg tablets used in combination according to dose.
Drug: Metformin
Metformin HCL 500 mg tablet twice daily titrating up to 1000 mg twice daily over 3 weeks.
Drug: Placebo to MK0893
Dose-matched placebo tablets to MK0893; taken orally once daily.
Drug: Placebo to Metformin
Dose-matched placebo tablets to metformin (500 mg); taken orally twice daily.
Study Arm (s)
  • Experimental: MK0893 80 mg
    MK0893 tablets totaling 80 mg once daily.
  • Experimental: MK0893 60 mg
    MK0893 tablets totaling 60 mg once daily.
  • Experimental: MK0893 40 mg
    MK0893 40 mg tablet once daily.
  • Experimental: MK0893 20 mg
    MK0893 20 mg tablet once daily.
  • Active Comparator: Metformin
    Metformin HCL 500 mg tablet twice daily BID titrating up to 1000 mg twice daily over 3 weeks.
  • Placebo Comparator: Placebo
    PLA tablets. 12 week treatment period.

Recruitment Information[ + expand ][ + ]

Recruitment StatusTerminated
Estimated Enrollment342
Estimated Completion DateMay 2008
Estimated Primary Completion DateMay 2008
Eligibility Criteria
Inclusion Criteria:

- Patients who have Type 2 Diabetes Mellitus, with suboptimal glucose control, while
either not on AHA (antihyperglycemic agent) therapy or on monotherapy or on low-dose
combination therapy

Exclusion Criteria:

- Patients have a history of Type 1 Diabetes Mellitus

- Patients taking insulin or thiazolidinedione (TZD, a peroxisome
proliferator-activated receptor [PPAR]-gamma agonist)

- Patients who have a contraindication to metformin
GenderBoth
Ages21 Years
Accepts Healthy VolunteersNo
ContactsNot Provided
Location CountriesNot Provided

Administrative Information[ + expand ][ + ]

NCT Number NCT00479466
Other Study ID Numbers0893-008
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 DateOctober 2013