NCT00943371TerminatedPhase 1
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
Conditions
Interventions
Drugs
Trial Snapshot
- Phase
- Phase 1
- Status
- Terminated
- Sponsor
- Merck Sharp & Dohme LLC
- Enrollment
- 28
- Primary Endpoint
- Safety and tolerability of MK6349 after single and divided rising doses based on assessment of clinical and laboratory evaluations and adverse experiences
Study Overview
Brief Summary
A single dose study to assess the safety, tolerability, pharmacokinetics and pharmacokinetics of MK6349 in Type 2 Diabetics.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Double (Participant, Investigator)
Eligibility Criteria
- Ages
- 18 Years to 55 Years (Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
1
Experimental
MK6349
Intervention: MK6349 (Drug)
Outcomes
Primary Outcomes
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
15-Hour weighted mean plasma glucose (WMG) concentration
Time Frame: 15 hours postdose
Secondary Outcomes
- 4-Hour weighted mean plasma glucose (WMG) concentration(4 hours postdose)
Investigators
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