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

Merck Sharp & Dohme (MSD)

Status and phase

Completed

Phase 1

Conditions

Type 2 Diabetes Mellitus

Treatments

Drug: MK-8245

Drug: Comparator: placebo

Study type

Interventional

Funder types

Industry

Identifiers

NCT00972322

8245-012

2009_655

MK-8245-012 (Other Identifier)

Details and patient eligibility

About

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.

Enrollment

56 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, 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