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

Merck Sharp & Dohme LLC56 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

Conditions

Type 2 Diabetes Mellitus

Interventions

MK-8245DRUG

MK-8245 50 mg twice daily for 28 days

Comparator: placeboDRUG

matching placebo to MK-8245 twice daily for 28 days

Eligibility

Sex: ALLMin age: 18 YearsMax age: 65 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

Change From Baseline in the 24-hour Weighted Mean Glucose (WMG)

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.

Time frame: Baseline and Day 28

Number of Participants Who Experienced Serious or Non-serious Adverse Events

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.

Time frame: Up to Day 31

Number of Participants Discontinuing Study Drug Due to an AE

Time frame: Up to Day 28

Data from ClinicalTrials.gov

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