A Randomized Double-Blind Placebo-Controlled Single and Multiple Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of MK-8655 in Subjects With Type 2 Diabetes
Overview
- Phase
- Phase 1
- Intervention
- MK-8655
- Conditions
- Type 2 Diabetes
- Sponsor
- Merck Sharp & Dohme LLC
- Enrollment
- 33
- Primary Endpoint
- Fasting Plasma Glucose (FPG)
- Status
- Completed
- Last Updated
- 7 years ago
Overview
Brief Summary
This study will assess the initial safety, tolerability, pharmacokinetics, and pharmacodynamics of MK-8655, after single and multiple daily oral administrations to participants with Type 2 Diabetes (T2DM). The study will assess the reduction in fasting plasma glucose concentrations from baseline after multiple daily administrations of MK-8655.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Male or female of non-child bearing potential
- •Body Mass Index ≤40 kg/m\^2
- •Diagnosis of Type 2 Diabetes (T2DM) and is either drug naive or is being treated with metformin only
- •In good health except for T2DM
- •Willing to follow a standard diet
- •Nonsmoker and/or no use of nicotine or nicotine-containing products for 6 months
Exclusion Criteria
- •Mentally or legally incapacitated
- •History of stroke, chronic seizures, or major neurological disorder
- •History of clinically significant endocrine (except T2DM), gastrointestinal, cardiovascular, hematological, hepatic, immunological, renal, respiratory, or genitourinary abnormalities or diseases
- •History of neoplastic or myeloproliferative diseases
- •Has clinical unstable or rapidly progressing diabetic retinopathy, neuropathy, and/or frequent nausea, bloating or vomiting, severe gastroesophageal reflux or early satiety
- •Has a history of Type 1 Diabetes and/or history of ketoacidosis
- •Use of any lipid-lowering therapies in the past 3 months
- •Non-permitted medication for a co-morbid condition
- •Excessive alcohol or caffeine use
- •Participation in another investigational study within 4 weeks prior to this study
Arms & Interventions
MK-8655 80 mg/MK-8655 320 mg
Participants received a single dose of MK-8655, 80 mg on Day 1 and then MK-8655 320 mg, once daily, starting on Day 3 for 14 consecutive days.
Intervention: MK-8655
Placebo
Participants received a single dose of placebo to MK-8655, 80 mg on Day 1 and then placebo to MK-8655 320 mg, once daily, starting on Day 3 for 14 consecutive days.
Intervention: Placebo
Outcomes
Primary Outcomes
Fasting Plasma Glucose (FPG)
Time Frame: Day 16 (Predose)
Blood for fasting plasma glucose (central laboratory) was obtained after at least 10 hours overnight fast.
Number of Participants With One or More Adverse Events
Time Frame: Up to 14 days after the last dose of study drug (Up to 31 days)
An adverse event is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study.
Number of Participants Discontinuing Study Drug Due to an Adverse Event
Time Frame: Up to 17 days
An adverse event is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study.
Secondary Outcomes
- True Geometric Mean Plasma Concentrations of MK-8655 After Single and Multiple Drug Doses at 24 Hours Post Dose (C24)(24 hours post dose on Days 1, 7, and 14)
- Change From Baseline at 2 Hours Oral Glucose Tolerance Test(Baseline and 2 hours after dosing on Days 1, 3, and 16)
- 24-Hour Weighted Mean Glucose (WMG)(Day 15: Predose, 2, 3, 4, 5, 6, 7, 8, 9, 11, 12, 13, 14, 15, 16, 18, 21, 23 hours post-dose.)