A Phase IIa, Multicenter, Double-Blind, Placebo-Controlled Clinical Trial to Study the Efficacy and Safety of MK8245 in Patients With Type 2 Diabetes Mellitus With Inadequate Glycemic Control
Overview
- Phase
- Phase 2
- Intervention
- MK8245 5 mg (twice a day) b.i.d.
- Conditions
- Type 2 Diabetes Mellitus
- Sponsor
- Merck Sharp & Dohme LLC
- Enrollment
- 14
- Primary Endpoint
- Change From Baseline in 24-hour Weighted Mean Glucose (WMG) at Week 4
- Status
- Terminated
- Last Updated
- 10 years ago
Overview
Brief Summary
A study to assess the safety and efficacy of MK8245 as monotherapy compared to placebo.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Have Type 2 Diabetes Mellitus
- •18 to 65 years of age
Exclusion Criteria
- •History of Type 1 Diabetes or ketoacidosis
- •Have been treated with lipid lowering medications 4 weeks before starting the study
- •Have started on a weight loss program and not in the maintenance phase or have started weight loss medication within the last 12 weeks
- •Have had surgery in the last 30 days
- •History of active liver disease
- •History of coronary heart disease or congestive heart failure
- •Have had a stroke or transient ischemic neurological disorder in the past 6 months
- •Are Human Immunodeficiency Virus (HIV) Positive
Arms & Interventions
MK8245 5 mg b.i.d.
MK8245
Intervention: MK8245 5 mg (twice a day) b.i.d.
MK8245 50 mg b.i.d.
MK8245
Intervention: MK8245 50 mg b.i.d.
Placebo
Placebo
Intervention: Placebo
Outcomes
Primary Outcomes
Change From Baseline in 24-hour Weighted Mean Glucose (WMG) at Week 4
Time Frame: Baseline and Week 4
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 to be collected immediately prior to (sample -10 minutes), and 0, 15, 30, 60, 90, 120, and 180 minutes after each meal, and overnight (at midnight, 3 AM, and 5 AM) and fasting at 7 AM. Patients were to be domiciled for approximately 26 hours at the site where standard meals were provided and physical activity monitored.