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

Study Overview
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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

Official Title
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A Study of Higher Single Doses of MK-0941 in Type 2 Diabetics

Conditions
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Type 2 Diabetes

Intervention / Treatment
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* Drug: MK-0941
* Drug: Comparator: Placebo


Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Treatment Sequence 1<br>Period 1: Placebo - Period 2: 80 mg - Period 3: 100 mg - Period 4: Placebo - Period 5: 140 mg | Drug: MK-0941<br>* A single 60, 80, 100, 120 or 140 mg oral dose of MK-0941 will be administered in each period<br>Drug: Comparator: Placebo<br>* a single oral placebo will be administered in the designated period (Periods 1-5)<br>|
| Experimental: Treatment Sequence 2<br>Period 1: 60 mg - Period 2: 80 mg - Period 3: 100 mg - Period 4: 120 mg - Period 5: Placebo | Drug: MK-0941<br>* A single 60, 80, 100, 120 or 140 mg oral dose of MK-0941 will be administered in each period<br>Drug: Comparator: Placebo<br>* a single oral placebo will be administered in the designated period (Periods 1-5)<br>|
| Experimental: Treatment Sequence 3<br>Period 1: 60 mg - Period 2: Placebo - Period 3: 100 mg - Period 4: 120 mg - Period 5: 140 mg | Drug: MK-0941<br>* A single 60, 80, 100, 120 or 140 mg oral dose of MK-0941 will be administered in each period<br>Drug: Comparator: Placebo<br>* a single oral placebo will be administered in the designated period (Periods 1-5)<br>|
| Experimental: Treatment Sequence 4<br>Period 1: 60 mg - Period 2: 80 mg - Period 3: Placebo - Period 4: 120 mg - Period 5: 140 mg | Drug: MK-0941<br>* A single 60, 80, 100, 120 or 140 mg oral dose of MK-0941 will be administered in each period<br>Drug: Comparator: Placebo<br>* a single oral placebo will be administered in the designated period (Periods 1-5)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants Who Experienced One or More Adverse Events During the Study |  | Up to 30 days after the last dose of study drug | 
| Number of Participants Who Discontinued Study Drug Due to an Adverse Event | Only treatment-emergent adverse events were examined for this outcome measure. | Up to 6 weeks after the first dose of study drug |