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

Phase 1

Completed

• Conditions: Type 2 Diabetes
• Interventions: Drug: MK-0941

• Registration Number: NCT01106287
• Lead Sponsor: Merck Sharp & Dohme LLC

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2009-10
• Primary Completion: 2010-01
• Study Completion: 2010-03
• Study First Submitted: 2010-04-16
• Study First Submitted QC: 2010-04-16
• Study First Posted: 2010-04-19
• Results First Submitted: 2012-07-03
• Results First Submitted QC: 2012-11-15
• Results First Posted: 2012-12-13
• Status Verified: 2016-02
• Last Update Submitted: 2016-02-03
• Last Update Posted: 2016-02-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 13

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Treatment Sequence 1	MK-0941	Period 1: Placebo - Period 2: 80 mg - Period 3: 100 mg - Period 4: Placebo - Period 5: 140 mg
Treatment Sequence 3	MK-0941	Period 1: 60 mg - Period 2: Placebo - Period 3: 100 mg - Period 4: 120 mg - Period 5: 140 mg
Treatment Sequence 4	MK-0941	Period 1: 60 mg - Period 2: 80 mg - Period 3: Placebo - Period 4: 120 mg - Period 5: 140 mg
Treatment Sequence 2	MK-0941	Period 1: 60 mg - Period 2: 80 mg - Period 3: 100 mg - Period 4: 120 mg - Period 5: Placebo

Primary Outcome Measures

Name	Time	Method
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	Up to 6 weeks after the first dose of study drug	Only treatment-emergent adverse events were examined for this outcome measure.