Type 2 Diabetes
Conditions
Brief summary
This study will evaluate the safety and tolerability of single doses of MK-0941 based on assessment of clinical and laboratory adverse experiences
Interventions
DRUGMK-0941
A single 60, 80, 100, 120 or 140 mg oral dose of MK-0941 will be administered in each period
DRUGComparator: Placebo
a single oral placebo will be administered in the designated period (Periods 1-5)
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 65 Years
Healthy volunteers
No
Inclusion criteria
* Female participants of reproductive potential must test negative for pregnancy and agree to use two acceptable methods of birth control * Diagnosis of Type 2 Diabetes and is either being treated with diet and exercise alone or with a single or combination oral anti-hyperglycemic agent * No treatment with three of more anti-hyperglycemic agents or any treatment regimen that includes insulin * In good health (except for Type 2 Diabetes) * Willingness to follow a specific diet throughout the study (consisting of 50% carbohydrates, 20%protein and 30% fat) * Nonsmoker
Exclusion criteria
* History of stroke, chronic seizure or major neurological disorder * History of cancer * History of Type 1 Diabetes * Recent history of eye infection * Glaucoma or blindness * Eye surgery (by incision or laser) within the past three months
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants Who Experienced One or More Adverse Events During the Study | Up to 30 days after the last dose of study drug | — |
| Number of Participants Who Discontinued Study Drug Due to an Adverse Event | Up to 6 weeks after the first dose of study drug | Only treatment-emergent adverse events were examined for this outcome measure. |
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| MK-0941 60/80/100/120 mg/Pbo Treatment Sequence 1 | 4 |
| MK-0941 60/80/Pbo/ MK-0941 120/140 mg Treatment Sequence 2 | 3 |
| MK-0941 60 mg/Pbo/MK-0941 100/120/140 mg Treatment Sequence 3 | 3 |
| Pbo/MK-0941 80/100 mg/Pbo/MK-0941 140 mg Treatment Sequence 4 | 3 |
| Total | 13 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 |
|---|---|---|---|---|---|
| Overall Study | Adverse Event | 1 | 0 | 0 | 0 |
Baseline characteristics
| Characteristic | MK-0941 60/80/100/120 mg/Pbo | MK-0941 60/80/Pbo/ MK-0941 120/140 mg | MK-0941 60 mg/Pbo/MK-0941 100/120/140 mg | Pbo/MK-0941 80/100 mg/Pbo/MK-0941 140 mg | Total |
|---|---|---|---|---|---|
| Age, Continuous | 45.5 years STANDARD_DEVIATION 7.19 | 55.0 years STANDARD_DEVIATION 7.81 | 54.7 years STANDARD_DEVIATION 12.1 | 52.3 years STANDARD_DEVIATION 7.51 | 51.4 years STANDARD_DEVIATION 8.64 |
| Sex: Female, Male Female | 0 Participants | 2 Participants | 2 Participants | 2 Participants | 6 Participants |
| Sex: Female, Male Male | 4 Participants | 1 Participants | 1 Participants | 1 Participants | 7 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk | EG004 affected / at risk | EG005 affected / at risk |
|---|---|---|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — | — / — | — / — | — / — |
| other Total, other adverse events | 2 / 10 | 6 / 9 | 4 / 9 | 9 / 9 | 4 / 9 | 4 / 13 |
| serious Total, serious adverse events | 0 / 10 | 0 / 9 | 0 / 9 | 0 / 9 | 0 / 9 | 0 / 13 |
Outcome results
Primary
Number of Participants Who Discontinued Study Drug Due to an Adverse Event
Only treatment-emergent adverse events were examined for this outcome measure.
Time frame: Up to 6 weeks after the first dose of study drug
Population: All participants receiving any dose of MK-0941 of placebo.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| MK-0941 60 mg | Number of Participants Who Discontinued Study Drug Due to an Adverse Event | 0 participants |
| MK-0941 80 mg | Number of Participants Who Discontinued Study Drug Due to an Adverse Event | 0 participants |
| MK-0941 100 mg | Number of Participants Who Discontinued Study Drug Due to an Adverse Event | 0 participants |
| MK-0941 120 mg | Number of Participants Who Discontinued Study Drug Due to an Adverse Event | 0 participants |
| MK-0941 140 mg | Number of Participants Who Discontinued Study Drug Due to an Adverse Event | 0 participants |
| Placebo | Number of Participants Who Discontinued Study Drug Due to an Adverse Event | 0 participants |
Primary
Number of Participants Who Experienced One or More Adverse Events During the Study
Time frame: Up to 30 days after the last dose of study drug
Population: All participants receiving any dose of MK-0941 or placebo
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| MK-0941 60 mg | Number of Participants Who Experienced One or More Adverse Events During the Study | Adverse Event | 2 participants |
| MK-0941 60 mg | Number of Participants Who Experienced One or More Adverse Events During the Study | Drug-Related Adverse Event | 1 participants |
| MK-0941 80 mg | Number of Participants Who Experienced One or More Adverse Events During the Study | Adverse Event | 6 participants |
| MK-0941 80 mg | Number of Participants Who Experienced One or More Adverse Events During the Study | Drug-Related Adverse Event | 1 participants |
| MK-0941 100 mg | Number of Participants Who Experienced One or More Adverse Events During the Study | Adverse Event | 4 participants |
| MK-0941 100 mg | Number of Participants Who Experienced One or More Adverse Events During the Study | Drug-Related Adverse Event | 2 participants |
| MK-0941 120 mg | Number of Participants Who Experienced One or More Adverse Events During the Study | Adverse Event | 9 participants |
| MK-0941 120 mg | Number of Participants Who Experienced One or More Adverse Events During the Study | Drug-Related Adverse Event | 6 participants |
| MK-0941 140 mg | Number of Participants Who Experienced One or More Adverse Events During the Study | Adverse Event | 4 participants |
| MK-0941 140 mg | Number of Participants Who Experienced One or More Adverse Events During the Study | Drug-Related Adverse Event | 3 participants |
| Placebo | Number of Participants Who Experienced One or More Adverse Events During the Study | Adverse Event | 5 participants |
| Placebo | Number of Participants Who Experienced One or More Adverse Events During the Study | Drug-Related Adverse Event | 1 participants |