Back to resultsDose-Range Finding Study for MK0893 (0893-008)
Primary Purpose
Diabetes Mellitus, Type 2
Status
Terminated
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
MK0893
Metformin
Placebo to MK0893
Placebo to Metformin
Sponsored by
About this trial
This is an interventional treatment trial for Diabetes Mellitus, Type 2
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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm 5
Arm 6
Arm Type
Experimental
Experimental
Experimental
Experimental
Active Comparator
Placebo Comparator
Arm Label
MK0893 80 mg
MK0893 60 mg
MK0893 40 mg
MK0893 20 mg
Metformin
Placebo
Arm Description
MK0893 tablets totaling 80 mg once daily.
MK0893 tablets totaling 60 mg once daily.
MK0893 40 mg tablet once daily.
MK0893 20 mg tablet once daily.
Metformin HCL 500 mg tablet twice daily BID titrating up to 1000 mg twice daily over 3 weeks.
PLA tablets. 12 week treatment period.
Outcomes
Primary Outcome Measures
Change From Baseline to Week 12 in Fasting Plasma Glucose (FPG)
Secondary Outcome Measures
Change From Baseline to Week 12 in Hemoglobin A1c (HbA1c)
Change From Baseline to Week 12 in 2-Hour Post Prandial Glucose (PPG)
Full Information
NCT ID
NCT00479466
First Posted
May 25, 2007
Last Updated
September 8, 2015
Sponsor
Merck Sharp & Dohme LLC
1. Study Identification
Unique Protocol Identification Number
NCT00479466
Brief Title
Dose-Range Finding Study for MK0893 (0893-008)
Official Title
A 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
Study Type
Interventional
2. Study Status
Record Verification Date
September 2015
Overall Recruitment Status
Terminated
Why Stopped
Sufficient data regarding the dose-response to MK-0893 had been obtained from the first cohort of the study to assess the safety and efficacy
Study Start Date
July 2007 (undefined)
Primary Completion Date
May 2008 (Actual)
Study Completion Date
May 2008 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Merck Sharp & Dohme LLC
4. Oversight
5. Study Description
Brief Summary
A study to compare MK0893 to metformin or placebo for patients with Type 2 diabetes (Diabetes Mellitus).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetes Mellitus, Type 2
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
342 (Actual)
8. Arms, Groups, and Interventions
Arm Title
MK0893 80 mg
Arm Type
Experimental
Arm Description
MK0893 tablets totaling 80 mg once daily.
Arm Title
MK0893 60 mg
Arm Type
Experimental
Arm Description
MK0893 tablets totaling 60 mg once daily.
Arm Title
MK0893 40 mg
Arm Type
Experimental
Arm Description
MK0893 40 mg tablet once daily.
Arm Title
MK0893 20 mg
Arm Type
Experimental
Arm Description
MK0893 20 mg tablet once daily.
Arm Title
Metformin
Arm Type
Active Comparator
Arm Description
Metformin HCL 500 mg tablet twice daily BID titrating up to 1000 mg twice daily over 3 weeks.
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
PLA tablets. 12 week treatment period.
Intervention Type
Drug
Intervention Name(s)
MK0893
Intervention Description
MK0893 taken orally once daily; 20 mg and 40 mg tablets used in combination according to dose.
Intervention Type
Drug
Intervention Name(s)
Metformin
Intervention Description
Metformin HCL 500 mg tablet twice daily titrating up to 1000 mg twice daily over 3 weeks.
Intervention Type
Drug
Intervention Name(s)
Placebo to MK0893
Intervention Description
Dose-matched placebo tablets to MK0893; taken orally once daily.
Intervention Type
Drug
Intervention Name(s)
Placebo to Metformin
Intervention Description
Dose-matched placebo tablets to metformin (500 mg); taken orally twice daily.
Primary Outcome Measure Information:
Title
Change From Baseline to Week 12 in Fasting Plasma Glucose (FPG)
Time Frame
Week 12
Secondary Outcome Measure Information:
Title
Change From Baseline to Week 12 in Hemoglobin A1c (HbA1c)
Time Frame
Week 12
Title
Change From Baseline to Week 12 in 2-Hour Post Prandial Glucose (PPG)
Time Frame
Week 12
10. Eligibility
Sex
All
Minimum Age & Unit of Time
21 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Medical Monitor
Organizational Affiliation
Merck Sharp & Dohme LLC
Official's Role
Study Director
12. IPD Sharing Statement
Learn more about this trial
Dose-Range Finding Study for MK0893 (0893-008)
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