Single Doses of MK-0941 in Type 2 Diabetics (MK-0941-027)

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

13 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-10-31

Study Completion Date

2010-03-31

Brief Summary

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This study will evaluate the safety and tolerability of single doses of MK-0941 based on assessment of clinical and laboratory adverse experiences

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Detailed Description

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Conditions

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Type 2 Diabetes

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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Treatment Sequence 1

Period 1: Placebo - Period 2: 80 mg - Period 3: 100 mg - Period 4: Placebo - Period 5: 140 mg

Group Type EXPERIMENTAL

MK-0941

Intervention Type DRUG

A single 60, 80, 100, 120 or 140 mg oral dose of MK-0941 will be administered in each period

Comparator: Placebo

Intervention Type DRUG

a single oral placebo will be administered in the designated period (Periods 1-5)

Treatment Sequence 2

Period 1: 60 mg - Period 2: 80 mg - Period 3: 100 mg - Period 4: 120 mg - Period 5: Placebo

Group Type EXPERIMENTAL

MK-0941

Intervention Type DRUG

A single 60, 80, 100, 120 or 140 mg oral dose of MK-0941 will be administered in each period

Comparator: Placebo

Intervention Type DRUG

a single oral placebo will be administered in the designated period (Periods 1-5)

Treatment Sequence 3

Period 1: 60 mg - Period 2: Placebo - Period 3: 100 mg - Period 4: 120 mg - Period 5: 140 mg

Group Type EXPERIMENTAL

MK-0941

Intervention Type DRUG

A single 60, 80, 100, 120 or 140 mg oral dose of MK-0941 will be administered in each period

Comparator: Placebo

Intervention Type DRUG

a single oral placebo will be administered in the designated period (Periods 1-5)

Treatment Sequence 4

Period 1: 60 mg - Period 2: 80 mg - Period 3: Placebo - Period 4: 120 mg - Period 5: 140 mg

Group Type EXPERIMENTAL

MK-0941

Intervention Type DRUG

A single 60, 80, 100, 120 or 140 mg oral dose of MK-0941 will be administered in each period

Comparator: Placebo

Intervention Type DRUG

a single oral placebo will be administered in the designated period (Periods 1-5)

Interventions

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MK-0941

A single 60, 80, 100, 120 or 140 mg oral dose of MK-0941 will be administered in each period

Intervention Type DRUG

Comparator: Placebo

a single oral placebo will be administered in the designated period (Periods 1-5)

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Female participants of reproductive potential must test negative for pregnancy and agree to use two acceptable methods of birth control
* Diagnosis of Type 2 Diabetes and is either being treated with diet and exercise alone or with a single or combination oral anti-hyperglycemic agent
* No treatment with three of more anti-hyperglycemic agents or any treatment regimen that includes insulin
* In good health (except for Type 2 Diabetes)
* Willingness to follow a specific diet throughout the study (consisting of 50% carbohydrates, 20%protein and 30% fat)
* Nonsmoker

Exclusion Criteria

* History of stroke, chronic seizure or major neurological disorder
* History of cancer
* History of Type 1 Diabetes
* Recent history of eye infection
* Glaucoma or blindness
* Eye surgery (by incision or laser) within the past three months

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No