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

Phase 1

Completed

• Conditions: Type 2 Diabetes Mellitus
• Interventions: Drug: MK-8245

• Registration Number: NCT00972322
• Lead Sponsor: Merck Sharp & Dohme LLC

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2009-08-24
• Study First Submitted: 2009-09-03
• Study First Submitted QC: 2009-09-03
• Study First Posted: 2009-09-04
• Primary Completion: 2010-01-12
• Study Completion: 2010-01-26
• Results First Submitted: 2014-05-14
• Results First Submitted QC: 2014-05-14
• Results First Posted: 2014-06-12
• Status Verified: 2018-08
• Last Update Submitted: 2018-08-10
• Last Update Posted: 2018-09-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 56

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
MK-8245 50 mg	MK-8245	MK-8245, 50 mg, twice daily for 28 days

Primary Outcome Measures

Name	Time	Method
Change From Baseline in the 24-hour Weighted Mean Glucose (WMG)	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	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	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.