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-1403. The study will also measure what happens to MK-1403 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-1403 + additive coformulation
MK-1403 + additive coformulation is a co-formulated product of MK-1403 administered orally.
DRUGPlacebo + additive coformulation
Placebo + additive coformulation is a co-formulated product of placebo administered orally.
Sponsors
Merck Sharp & Dohme LLC
Study design
Allocation
RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* Has a confirmed diagnosis of Type 2 diabetes mellitus (T2DM) * Has body mass index (BMI) between 18 and 40 kg/m\^2, inclusive
Exclusion criteria
* Has Type 1 diabetes mellitus or secondary types of diabetes * Has a history of congestive heart failure (New York Heart Association \[NYHA\] Class 3 or 4) * Has history of myocardial infarction, uncontrolled arrhythmias, cardiac revascularization, angina, unstable peripheral arterial disease and/or stroke * Has history of cancer (malignancy) * Has positive test(s) for hepatitis B surface antigen (HBsAg), hepatitis C antibodies, or human immunodeficiency virus (HIV) * Has a history of gastrointestinal (GI) disease which might affect food and drug absorption, or has had gastric bypass or similar surgery
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of participants who experience one or more adverse events (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. The number of participants who experience one or more AEs will be reported. |
| Number of participants who discontinue study intervention due to adverse events | Up to approximately 14 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. The number of participants who discontinue study intervention due to an AE will be reported. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change from Baseline in Placebo-Corrected High Sensitivity C-Reactive Protein (hsCRP) Serum Concentration | Baseline and 24-hours postdose on Day 14 | Blood samples will be collected to determine the change from baseline in placebo-corrected hsCRP. |
| Plasma concentration of MK-1403 at 24 Hours Postdose (C24) on Day 14 | 24-hour postdose on Day 14 | Blood samples will be collected to determine the C24 of MK-1403 in plasma on Day 14. |
Countries
United States
Contacts
STUDY_DIRECTORMedical Director
Merck Sharp & Dohme LLC
Outcome results
None listed