Pharmacokinetics and Pharmacodynamics of MK-8245 in Participants With Type 2 Diabetes (MK-8245-012)

• Status: Completed
• Trial end date: 2010-01-26
• Target enrollment: 0
• Participant gender: All

Summary

This study will assess the safety, tolerability, pharmacokinetics, and glucose lowering activity of MK-8245 in participants with type 2 diabetes. The primary hypothesis of the study is that after 4 weeks of treatment, MK-8245 produces a greater reduction in 24 hour weighted mean glucose (WMG) from baseline than placebo.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Merck Sharp & Dohme Corp.

Criteria

Inclusion Criteria:

• Subject has a diagnosis of type 2 diabetes and is being treated with diet and exercise alone, a single oral anti-hyperglycemic agent or a combination of two oral anti-hyperglycemic agents

• Subject is willing to follow a weight-maintaining diet and exercise program during the study

• Subject is a nonsmoker or is willing to limit smoking to 10 cigarettes per day while in the clinical research unit

Exclusion Criteria:

• Subject has a history of stroke, chronic seizures, or major neurological disorder

• Subject has a history of cancer, except certain skin and cervical cancers or cancer that was successfully treated 10 or more years prior to screening

• Subject has a history of type 1 diabetes

• Subject has used contact lenses within the last 6 months

• Subject has used any lipid-lowering therapy in the last 3 months, except statins, Zetia, or Vytorin

• Subject has more than 3 alcoholic beverages per day

• Subject has more than 6 servings of caffeine a day

• Subject has participated in a previous MK8245 study