A Clinical Trial of MK-1403 in Participants With Type 2 Diabetes Mellitus (MK-1403-006)
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: MK-1403 + additive coformulation, Placebo + additive coformulation.
- Who it may be relevant to
- Registry conditions: Diabetes Mellitus, Type 2. Basic parameters: 18 years — 75 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
A Multiple Dose Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of MK-1403 in Participants With Type 2 Diabetes Mellitus
Overview
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
- Drug MK-1403 + additive coformulation
MK-1403 + additive coformulation is a co-formulated product of MK-1403 administered orally. - Drug Placebo + additive coformulation
Placebo + additive coformulation is a co-formulated product of placebo administered orally.
Primary outcome measures
- Number of participants who experience one or more adverse events (AE) [Time frame: Up to approximately 28 days]
- Number of participants who discontinue study intervention due to adverse events [Time frame: Up to approximately 14 days]
Secondary outcome measures (2)
- Change from Baseline in Placebo-Corrected High Sensitivity C-Reactive Protein (hsCRP) Serum Concentration [Time frame: Baseline and 24-hours postdose on Day 14]
- Plasma concentration of MK-1403 at 24 Hours Postdose (C24) on Day 14 [Time frame: 24-hour postdose on Day 14]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Sequential
- Masking
- Triple blind
- Primary purpose
- Treatment
Study locations
United States · 5 centers
- Anaheim Clinical Trials ( Site 0006) — Anaheim
- ProSciento Inc. ( Site 0001) — Chula Vista
- Advanced Pharma CR, LLC ( Site 0003) — Miami
- QPS-MRA, LLC ( Site 0004) — South Miami
- Bio-Kinetic Clinical Applications, LLC dba QPS-MO ( Site 0005) — Springfield
Identifiers
NCT: NCT07242469 · 1403-006