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

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

56 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-08-24

Study Completion Date

2010-01-26

Brief Summary

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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.

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Detailed Description

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Conditions

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Type 2 Diabetes Mellitus

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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MK-8245 50 mg

MK-8245, 50 mg, twice daily for 28 days

Group Type EXPERIMENTAL

MK-8245

Intervention Type DRUG

MK-8245 50 mg twice daily for 28 days

Placebo

Placebo to MK-8245, 50 mg, twice daily

Group Type PLACEBO_COMPARATOR

Comparator: placebo

Intervention Type DRUG

matching placebo to MK-8245 twice daily for 28 days

Interventions

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MK-8245

MK-8245 50 mg twice daily for 28 days

Intervention Type DRUG

Comparator: placebo

matching placebo to MK-8245 twice daily for 28 days

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No