A Multiple Dose Investigational Drug Study in Patients With Type 2 Diabetes (MK-0941-005)
Primary Purpose
Type 2 Diabetes Mellitus
Status
Completed
Phase
Phase 1
Locations
Study Type
Interventional
Intervention
MK0941
Comparator: Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Type 2 Diabetes Mellitus
Eligibility Criteria
Inclusion Criteria:
- Nonsmoking Male or Female (of non-child bearing potential)
- Diagnosis of Type 2 Diabetes and is being treated with diet and exercise alone or with less than 3 oral anti-hyperglycemic agents
- Panel E only (MK0941 60 mg before 2 meals each day): diagnosis of Type 2 Diabetes and is on a dose of metformin of greater than or equal to 1500 mg for 8 weeks or more
Exclusion Criteria:
- Subject is on insulin or a peroxisome proliferator-activated receptor (PPAR) agonist
- Subject is on 3 or more oral anti-diabetes medications
- Subject has a history of type 1 diabetes
- Subject has a diagnosis of glaucoma or is blind
- Subject has had trauma to one or both eyes
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
MK0941
Placebo
Arm Description
Outcomes
Primary Outcome Measures
Participants With Any Clinical Adverse Experience
Participants Discontinued Because of Any Clinical Adverse Experience
Secondary Outcome Measures
Area Under the Concentration-time Curve (AUC0-24) of MK-0941 After Multiple Doses of MK0941
Maximum Concentration (Cmax) of MK-0941 After Multiple Doses of MK-0941
Time to Maximum Concentration (Tmax) of MK-0941 After Multiple Doses of MK-0941
Apparent Terminal Elimination Half-life (T1/2) of MK-0941 After Multiple Doses of MK0941
Concentration of MK-0941 at 24 Hours (C24hr) After Multiple Doses of MK-0941
Full Information
NCT ID
NCT00511667
First Posted
August 2, 2007
Last Updated
August 23, 2016
Sponsor
Merck Sharp & Dohme LLC
1. Study Identification
Unique Protocol Identification Number
NCT00511667
Brief Title
A Multiple Dose Investigational Drug Study in Patients With Type 2 Diabetes (MK-0941-005)
Official Title
A Multi-Center, Randomized, Double-Blind, Placebo-Controlled, Sequential Panel Study to Assess the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of MK0941 After Multiple Daily Administration of MK0941 Before Each Meal (q.a.c.) in Subjects With Type 2 Diabetes
Study Type
Interventional
2. Study Status
Record Verification Date
August 2016
Overall Recruitment Status
Completed
Study Start Date
May 2007 (undefined)
Primary Completion Date
April 2008 (Actual)
Study Completion Date
April 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 multiple dose study to assess the safety and pharmacokinetics of an investigational drug in patients with type 2 diabetes. The primary hypotheses of the study are that multiple daily MK-0941 in subjects with T2DM with or without adequate control on metformin will be sufficiently safe and well tolerated to permit continued clinical investigation.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Type 2 Diabetes Mellitus
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
70 (Actual)
8. Arms, Groups, and Interventions
Arm Title
MK0941
Arm Type
Experimental
Arm Title
Placebo
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
MK0941
Intervention Description
MK0941 10 mg, 20 mg, 30 mg, or 40 mg before each meal or before 2 meals each day, or 60 mg before 2 meals each day
Intervention Type
Drug
Intervention Name(s)
Comparator: Placebo
Intervention Description
Placebo 10 mg, 20 mg, 30 mg, or 40 mg before each meal or before 2 meals each day, or 60 mg before 2 meals each day
Primary Outcome Measure Information:
Title
Participants With Any Clinical Adverse Experience
Time Frame
Approximately 30 days after last dose of study drug (14 days for participants receiving MK0941 40 mg before each meal)
Title
Participants Discontinued Because of Any Clinical Adverse Experience
Time Frame
Approximately 30 days after last dose of study drug (14 days for participants receiving MK0941 40 mg before each meal)
Secondary Outcome Measure Information:
Title
Area Under the Concentration-time Curve (AUC0-24) of MK-0941 After Multiple Doses of MK0941
Time Frame
Up to 72 hours after dosing (up to 24 hours for participants receiving MK0941 60 mg before 2 meals each day)
Title
Maximum Concentration (Cmax) of MK-0941 After Multiple Doses of MK-0941
Time Frame
Up to 72 hours after dosing (up to 24 hours for participants receiving MK0941 60 mg before 2 meals each day)
Title
Time to Maximum Concentration (Tmax) of MK-0941 After Multiple Doses of MK-0941
Time Frame
Up to 72 hours after dosing (up to 24 hours for participants receiving MK0941 60 mg before 2 meals each day)
Title
Apparent Terminal Elimination Half-life (T1/2) of MK-0941 After Multiple Doses of MK0941
Time Frame
Up to 72 hours after dosing (up to 24 hours for participants receiving MK0941 60 mg before 2 meals each day)
Title
Concentration of MK-0941 at 24 Hours (C24hr) After Multiple Doses of MK-0941
Time Frame
Up to 72 hours after dosing (up to 24 hours for participants receiving MK0941 60 mg before 2 meals each day)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Nonsmoking Male or Female (of non-child bearing potential)
Diagnosis of Type 2 Diabetes and is being treated with diet and exercise alone or with less than 3 oral anti-hyperglycemic agents
Panel E only (MK0941 60 mg before 2 meals each day): diagnosis of Type 2 Diabetes and is on a dose of metformin of greater than or equal to 1500 mg for 8 weeks or more
Exclusion Criteria:
Subject is on insulin or a peroxisome proliferator-activated receptor (PPAR) agonist
Subject is on 3 or more oral anti-diabetes medications
Subject has a history of type 1 diabetes
Subject has a diagnosis of glaucoma or is blind
Subject has had trauma to one or both eyes
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
A Multiple Dose Investigational Drug Study in Patients With Type 2 Diabetes (MK-0941-005)
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