Back to resultsA Single-Dose Study of MK6349 in Patients With Type 2 Diabetes (6349-002)
Primary Purpose
Type 2 Diabetes Mellitus
Status
Terminated
Phase
Phase 1
Locations
Study Type
Interventional
Intervention
MK6349
Comparator: Placebo to MK6349
Sponsored by
About this trial
This is an interventional treatment trial for Type 2 Diabetes Mellitus
Eligibility Criteria
Inclusion Criteria:
- Subject is a non-smoking male or female (females must be postmenopausal, had a tubal ligation or a hysterectomy) between 18 to 55 years of age
- Subject has Type 2 Diabetes and is currently being treated with diet and exercise alone or with less than 3 oral diabetes drugs
Exclusion Criteria:
- Subject is on insulin or a PPAR agonist medication
- Subject has Type 1 diabetes
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
1
2
Arm Description
MK6349
Placebo to MK6349
Outcomes
Primary Outcome Measures
Safety and tolerability of MK6349 after single and divided rising doses based on assessment of clinical and laboratory evaluations and adverse experiences
15-Hour weighted mean plasma glucose (WMG) concentration
Secondary Outcome Measures
4-Hour weighted mean plasma glucose (WMG) concentration
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00943371
Brief Title
A Single-Dose Study of MK6349 in Patients With Type 2 Diabetes (6349-002)
Official Title
A Double-Blind, Randomized, Placebo-Controlled, Single and Divided Rising-Dose, Sequential Panel Study to Assess the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of MK6349 in Subjects With Type 2 Diabetes
Study Type
Interventional
2. Study Status
Record Verification Date
August 2015
Overall Recruitment Status
Terminated
Study Start Date
August 2007 (undefined)
Primary Completion Date
September 2007 (Actual)
Study Completion Date
May 2009 (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 single dose study to assess the safety, tolerability, pharmacokinetics and pharmacokinetics of MK6349 in Type 2 Diabetics.
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
28 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Experimental
Arm Description
MK6349
Arm Title
2
Arm Type
Placebo Comparator
Arm Description
Placebo to MK6349
Intervention Type
Drug
Intervention Name(s)
MK6349
Intervention Description
Panel A: MK6349 in single doses beginning at 16 mg and rising to 90 mg in up to four treatment periods Panel B: MK6349 in single doses beginning at 90 mg and rising to 160 mg in up to four treatment periods Panel C: MK6349 in divided doses beginning at 20 mg q.a.c. (before each meal) and rising to 50 mg q.a.c. in up to four treatment periods
Intervention Type
Drug
Intervention Name(s)
Comparator: Placebo to MK6349
Intervention Description
Panel A: Placebo to MK6349 in single doses in up to four treatment periods Panel B: Placebo to MK6349 in single doses in up to four treatment periods Panel C: MK6349 in divided doses q.a.c. (before each meal) in up to four treatment periods
Primary Outcome Measure Information:
Title
Safety and tolerability of MK6349 after single and divided rising doses based on assessment of clinical and laboratory evaluations and adverse experiences
Time Frame
Through 30 days after the last dose of study drug
Title
15-Hour weighted mean plasma glucose (WMG) concentration
Time Frame
15 hours postdose
Secondary Outcome Measure Information:
Title
4-Hour weighted mean plasma glucose (WMG) concentration
Time Frame
4 hours postdose
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Subject is a non-smoking male or female (females must be postmenopausal, had a tubal ligation or a hysterectomy) between 18 to 55 years of age
Subject has Type 2 Diabetes and is currently being treated with diet and exercise alone or with less than 3 oral diabetes drugs
Exclusion Criteria:
Subject is on insulin or a PPAR agonist medication
Subject has Type 1 diabetes
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 Single-Dose Study of MK6349 in Patients With Type 2 Diabetes (6349-002)
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