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 |
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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