A Clinical Trial of MK-1403 in Participants With Type 2 Diabetes Mellitus (MK-1403-006)
ConditionDiabetes Mellitus, Type 2
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18-75
SponsorMerck Sharp & Dohme LLC
About this trial
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.
Eligibility criteria
Qualifiers
Has a confirmed diagnosis of Type 2 diabetes mellitus (T2DM)
Has body mass index (BMI) between 18 and 40 kg/m², inclusive
Disqualifiers
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)
Trial design
Treatments tested in this trial
- MK-1403 + additive coformulation
- Placebo + additive coformulation
Treatment groups
52 Participants
are divided into 4 treatment groupsLocations
5Anaheim Clinical Trials ( Site 0006)92801, AnaheimCalifornia, United States
ProSciento Inc. ( Site 0001)91911, Chula VistaCalifornia, United States
Advanced Pharma CR, LLC ( Site 0003)33147, MiamiFlorida, United States
QPS-MRA, LLC ( Site 0004)33143, South MiamiFlorida, United States
Sponsors and collaborators
Merck Sharp & Dohme LLC
Lead sponsor
Source ClinicalTrials.gov