A Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of MK8245 (8245-004)(COMPLETED)

Merck Sharp & Dohme (MSD)

Status and phase: Completed; Phase 1

Conditions: Type 2 Diabetes

Treatments: Drug: MK8245; Drug: Comparator: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT00790556

2008_582

8245-004

Details and patient eligibility

About

A 2-period crossover study to assess the safety, tolerability and glucose-lowering effects of MK8245.

Full 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 continued clinical investigation.

Enrollment: 14 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Double Blind

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14 participants in 2 patient groups, including a placebo group

1

Experimental group

Description:

MK8245

Treatment:

Drug: MK8245

2

Placebo Comparator group

Description:

Placebo Comparator

Treatment:

Drug: Comparator: Placebo