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

Merck Sharp & Dohme (MSD)

Status and phase: Completed; Phase 1

Conditions: Type 2 Diabetes

Treatments: Drug: Comparator: Placebo; Drug: MK-0941

Study type: Interventional

Funder types: Industry

Identifiers

NCT01106287

MK-0941-027 (Other Identifier)

2010_526 (Other Identifier)

0941-027

Details and patient eligibility

About

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

Enrollment: 13 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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13 participants in 4 patient groups

Treatment Sequence 1

Experimental group

Description:

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

Treatment:

Drug: Comparator: Placebo

Drug: MK-0941

Treatment Sequence 2

Experimental group

Description:

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

Treatment:

Drug: Comparator: Placebo

Drug: MK-0941

Treatment Sequence 3

Experimental group

Description:

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

Treatment:

Drug: Comparator: Placebo

Drug: MK-0941

Treatment Sequence 4

Experimental group

Description:

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

Treatment:

Drug: Comparator: Placebo

Drug: MK-0941