| Trial ID: | L6254 |
| Source ID: | NCT00790556
|
| Associated Drug: |
Mk8245
|
| Title: |
A Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of MK8245 (8245-004)(COMPLETED)
|
| Acronym: |
|
| Status: |
COMPLETED
|
| Study Results: |
YES
|
| Results: |
https://ClinicalTrials.gov/show/NCT00790556/results
|
| Conditions: |
Type 2 Diabetes
|
| Interventions: |
DRUG: MK8245|DRUG: Comparator: Placebo
|
| Outcome Measures: |
Primary: Number of Participants Experiencing Clinical and Laboratory Adverse Events (CAEs and LAEs), An LAE is defined as any unfavorable \& unintended change in the chemistry of the body temporally associated with the use of study product, whether or not considered related to the use of the product. A CAE is defined similarly but also includes changes in structure or function of the body. Serious AEs are those occuring that result in one or more of the pre-specified outcome(s) that meet the criteria of seriousness, including death, life-threatening, significant disability, or hospitalization, etc. Drug-relatedness was determined by the investigator based on clinical judgement., 56 days|Mean Change From Baseline in Hepatic Glucose Production (HGP) at Day 14, Changes in HGP were determined during a euglycemic clamp procedure. HGP was evaluated as milligrams per kilogram of glucose produced per minute., Day 14 of each 14-day Treatment Period | Other: Hepatic Glucose Production (HGP) at Baseline, Baseline
|
| Sponsor/Collaborators: |
Sponsor: Merck Sharp & Dohme LLC
|
| Gender: |
ALL
|
| Age: |
ADULT, OLDER_ADULT
|
| Phases: |
PHASE1
|
| Enrollment: |
14
|
| Study Type: |
INTERVENTIONAL
|
| Study Designs: |
Allocation: RANDOMIZED|Intervention Model: CROSSOVER|Masking: DOUBLE (PARTICIPANT, INVESTIGATOR)|Primary Purpose: TREATMENT
|
| Start Date: |
2008-10
|
| Completion Date: |
2009-09
|
| Results First Posted: |
2011-01-20
|
| Last Update Posted: |
2016-02-17
|
| Locations: |
|
| URL: |
https://clinicaltrials.gov/show/NCT00790556
|
