Diabetes Mellitus, Type 2
Conditions
Brief summary
The purpose of this study is to learn about the safety and if people tolerate a study medicine called MK-2828. The study will also measure what happens to MK-2828 in the body of a person with type 2 diabetes (T2D) over time (pharmacokinetic or PK study), and how it affects the amount of high-sensitivity C-reactive protein (hsCRP) in a person's blood.
Interventions
DRUGMK-2828
Oral capsule of MK-2828 taken once per day for 28 days.
DRUGPlacebo
Placebo to match MK-2828 oral capsule, taken once per day for 28 days.
Sponsors
Merck Sharp & Dohme LLC
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
24 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
The main inclusion criteria include but are not limited to the following: * With the exception of type 2 diabetes mellitus (T2DM), is in generally good health * Has a history of T2DM for ≥1 year at the time of screening based on self-reporting * Has a baseline HbA1C level of ≤10% at the time of screening * Has a stable weight (based on self-reporting) defined as ≤5 kg gain or loss of body weight for at least 3 months before Visit 1/Screening * T2DM treated with lifestyle modification alone or with stable doses (no significant change for ≥3 months from Visit 1/Screening, based on self-reporting) of ≤ 3 oral anti-diabetic medications and anticipated not to require dose adjustments during the study duration * Body mass index (BMI) between 25 and 40 kg/m2, inclusive
Exclusion criteria
The main
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants Who Experience an Adverse Event (AE) | Up to approximately 42 days | An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. |
| Number of Participants Who Discontinue Study Treatment Due to an AE | Up to approximately 28 days | An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Plasma Concentration of MK-2828 at 24 Hours Postdose (C24) After Day 1 Dose | 24 hours post-Day 1 dose | Blood samples will be collected to determine the C24 of MK-2828 in plasma after the Day 1 dose. |
| Plasma Concentration of MK-2828 at 24 Hours Postdose (C24) After Day 27 Dose | Predose on Day 28 | Blood samples will be collected to determine the C24 of MK-2828 in plasma after the Day 27 dose. |
| Change from Baseline in Placebo Corrected High-Sensitivity C-Reactive Protein (hsCRP) Serum Concentration | Baseline and Predose Day 28 | Blood samples will be collected to determine the change from baseline in placebo corrected hsCRP. |
Countries
United States
Contacts
STUDY_DIRECTORMedical Director
Merck Sharp & Dohme LLC
Outcome results
None listed