Type 2 Diabetes Mellitus
Conditions
Brief summary
A single dose study to assess the safety, tolerability, pharmacokinetics and pharmacokinetics of MK6349 in Type 2 Diabetics.
Interventions
DRUGMK6349
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
DRUGComparator: Placebo to MK6349
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
Sponsors
Merck Sharp & Dohme LLC
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 55 Years
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Safety and tolerability of MK6349 after single and divided rising doses based on assessment of clinical and laboratory evaluations and adverse experiences | Through 30 days after the last dose of study drug |
| 15-Hour weighted mean plasma glucose (WMG) concentration | 15 hours postdose |
Secondary
| Measure | Time frame |
|---|---|
| 4-Hour weighted mean plasma glucose (WMG) concentration | 4 hours postdose |
Outcome results
None listed