A Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of MK8245 (8245-004)(COMPLETED)
A 2-period crossover study to assess the safety, tolerability and glucose-lowering effects of MK8245.
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
|Official Title:||A Multiple-Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of MK8245.|
- Number of Participants Experiencing Clinical and Laboratory Adverse Events (CAEs and LAEs) [ Time Frame: 56 days ] [ Designated as safety issue: Yes ]
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.
- Mean Change From Baseline in Hepatic Glucose Production (HGP) at Day 14 [ Time Frame: Day 14 of each 14-day Treatment Period ] [ Designated as safety issue: No ]Changes in HGP were determined during a euglycemic clamp procedure. HGP was evaluated as milligrams per kilogram of glucose produced per minute.
- Hepatic Glucose Production (HGP) at Baseline [ Time Frame: Baseline ] [ Designated as safety issue: No ]
|Study Start Date:||October 2008|
|Study Completion Date:||September 2009|
|Primary Completion Date:||September 2009 (Final data collection date for primary outcome measure)|
MK8245 50 mg capsules twice daily for 13 days. On Day 14, only the morning dose of study medication will be taken. There will be a 14 day washout period. Patients will then crossover to MK8245 placebo capsules twice daily for 13 days. On Day 14, only the morning dose of study drug will be taken.
Placebo Comparator: 2
Drug: Comparator: Placebo
MK8245 placebo capsules twice daily for 13 days. On Day 14, only the morning dose of study medication will be taken. There will be a 14 day washout period. Patients will then crossover to MK8245 50 mg capsules twice daily for 13 days. On Day 14, only the morning dose of study drug will be taken.
Hypothesis: Multiple doses of MK-8245 are sufficiently safe and well tolerated in patients with Type 2 diabetes based on an assessment of clinical and laboratory adverse experiences (AEs), to permit continued clinical investigation.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00790556
|Study Director:||Medical Monitor||Merck Sharp & Dohme Corp.|