Phase 1 Completed N=33 Randomized Double-blind Treatment

Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of MK-8655 in Participants With Type 2 Diabetes (MK-8655-002)

Type 2 Diabetes

Source: ClinicalTrials.gov NCT01640873 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Nov 2018

Primary outcomePrimary: Number of Participants With One or More Adverse Events — 11; 7 Participants

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.

Outcome Measures

Outcome	Result	p-value
PRIMARY Number of Participants With One or More Adverse Events	11; 7	—
PRIMARY Number of Participants Discontinuing Study Drug Due to an Adverse Event	0; 0	—
PRIMARY Fasting Plasma Glucose (FPG)	195.5; 211.8	0.356
SECONDARY True Geometric Mean Plasma Concentrations of MK-8655 After Single and Multiple Drug Doses at 24 Hours Post Dose (C24)	0.133; 0.477; 0.549; 0.612	—
SECONDARY 24-Hour Weighted Mean Glucose (WMG)	205.5; 199.9	0.2714
SECONDARY Change From Baseline at 2 Hours Oral Glucose Tolerance Test	164.0; 134.7; 162.3; 135.0; 172.4; 156.1	0.060

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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT01640873). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.