Status:
COMPLETED
A Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of MK8245 (8245-004)(COMPLETED)
Lead Sponsor:
Merck Sharp & Dohme LLC
Conditions:
Type 2 Diabetes
Eligibility:
All Genders
18-65 years
Phase:
PHASE1
Brief Summary
A 2-period crossover study to assess the safety, tolerability and glucose-lowering effects of MK8245.
Detailed Description
Hypothesis: Multiple doses of MK-8245 are sufficiently safe and well tolerated in patients with Type 2 diabetes based on an assessment of clinical and laboratory adverse experiences (AEs), to permit c...
Eligibility Criteria
Inclusion
- Subject has a diagnosis of Type 2 Diabetes and is being treated with diet and exercise alone or a single oral anti-hyperglycemic agent
- Subject is willing to follow the weight-maintaining diet and exercise program or equivalent beginning 4 weeks before receiving study drug, throughout the study and until the post study visit
- Subject has been a nonsmoker and/or has not used nicotine-containing products for at least approximately 6 months
Exclusion
- Subject has a history of stroke, chronic seizures, or major neurological disorder
- Subject has a history of neoplastic disease (except non-melanomatous skin carcinoma, carcinoma in situ of the cervix, other malignancies successfully treated at least 10 years prior to screening, or malignancies deemed highly unlikely to recur.)
- Subject has a history of Type 1 Diabetes Mellitus and/or history of ketoacidosis
- Subject has a history of contact lens use within approximately the previous 6 months
- Subject has been diagnosed with dry eye syndrome
- Subject has used lipid-lowering therapies in the past 3 months (Subjects on a stable monotherapy dose of statins may be included)
- Subject has had major surgery, donated or lost 1 unit of blood or participated in another investigational study within 4 weeks of starting in the study
Key Trial Info
Start Date :
October 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2009
Estimated Enrollment :
14 Patients enrolled
Trial Details
Trial ID
NCT00790556
Start Date
October 1 2008
End Date
September 1 2009
Last Update
February 17 2016
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