Phase 1
Completed N=14
A Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of MK8245 (8245-004)(COMPLETED)
Source: ClinicalTrials.gov NCT00790556 ↗Enrolled (actual)
14
Serious AEs
0.0%
Results posted
Jan 2011
Primary outcomePrimary: Number of Participants Experiencing Clinical and Laboratory Adverse Events (CAEs and LAEs) — 4; 5; 0; 0 participants
Summary
A 2-period crossover study to assess the safety, tolerability and glucose-lowering effects of MK8245.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants Experiencing Clinical and Laboratory Adverse Events (CAEs and LAEs) |
4; 5; 0; 0; 0; 0 | — |
| PRIMARY Mean Change From Baseline in Hepatic Glucose Production (HGP) at Day 14 |
-1.09; -0.87 | — |
Eligibility Criteria
Inclusion Criteria
- 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 Criteria
- 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
Data sourced from ClinicalTrials.gov (NCT00790556). 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.