Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of MK-8655 in Participants With Type 2 Diabetes (MK-8655-002 AM1)



Status:Completed
Conditions:Diabetes
Therapuetic Areas:Endocrinology
Healthy:No
Age Range:Any
Updated:10/21/2012
Start Date:September 2012
End Date:November 2012
Contact:Toll Free Number
Phone:1-888-577-8839

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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


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.


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
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