Clinical trial NCT01640873: Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of MK-8655 in Participants With Type 2 Diabetes (MK-8655-002)
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Type 2 Diabetes
Keywords: Type 2 Diabetes
Lead sponsor: Merck Sharp & Dohme LLC
Sponsor class: INDUSTRY
First posted: 2012-07-16
Enrollment: 33
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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
* A history of significant multiple and/or severe allergies or anaphylactic reactions
* Regular user of any illicit drugs or history of alcohol abuse within 6 months

Primary outcomes:
measure: Number of Participants With One or More Adverse Events
timeFrame: Up to 14 days after the last dose of study drug (Up to 31 days)
measure: Number of Participants Discontinuing Study Drug Due to an Adverse Event
timeFrame: Up to 17 days
measure: Fasting Plasma Glucose (FPG)
timeFrame: Day 16 (Predose)
Secondary outcomes:
measure: True Geometric Mean Plasma Concentrations of MK-8655 After Single and Multiple Drug Doses at 24 Hours Post Dose (C24)
timeFrame: 24 hours post dose on Days 1, 7, and 14
measure: 24-Hour Weighted Mean Glucose (WMG)
timeFrame: Day 15: Predose, 2, 3, 4, 5, 6, 7, 8, 9, 11, 12, 13, 14, 15, 16, 18, 21, 23 hours post-dose.
measure: Change From Baseline at 2 Hours Oral Glucose Tolerance Test
timeFrame: Baseline and 2 hours after dosing on Days 1, 3, and 16
Other outcomes:
Locations:
Study officials:
affiliation: Merck Sharp & Dohme LLC
name: Medical Director
role: STUDY_DIRECTOR
References: