A Placebo-Controlled Multiple Dose Study to Evaluate the Pharmacokinetics and Pharmacokinetics of MK-8245 in Subjects With Type 2 Diabetes
Overview
- Phase
- Phase 1
- Intervention
- MK-8245
- Conditions
- Type 2 Diabetes Mellitus
- Sponsor
- Merck Sharp & Dohme LLC
- Enrollment
- 56
- Primary Endpoint
- Change From Baseline in the 24-hour Weighted Mean Glucose (WMG)
- Status
- Completed
- Last Updated
- 7 years ago
Overview
Brief 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.
Investigators
Eligibility 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
Arms & Interventions
MK-8245 50 mg
MK-8245, 50 mg, twice daily for 28 days
Intervention: MK-8245
Outcomes
Primary Outcomes
Change From Baseline in the 24-hour Weighted Mean Glucose (WMG)
Time Frame: Baseline and Day 28
The 24-hour WMG is derived from multiple glucose values collected during both fasting and post-meal periods. A "weighted" rather than a "simple" mean is used to avoid overrepresentation of post-meal glucose values. Blood samples for glucose were collected immediately prior to, and after each meal, and overnight and fasting one hour pre-dose.
Number of Participants Who Experienced Serious or Non-serious Adverse Events
Time Frame: Up to Day 31
An adverse event (AE) is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study. A serious AE is any untoward medical occurrence that results in death, is life threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, or is a congenital anomaly/birth defect.
Number of Participants Discontinuing Study Drug Due to an AE
Time Frame: Up to Day 28
An adverse event (AE) is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study.