A Multiple-Dose Study of MK-1006 (MK-1006-004)(TERMINATED)

Merck Sharp & Dohme (MSD)

Status and phase: Terminated; Phase 1

Conditions: Type 2 Diabetes

Treatments: Drug: MK-1006; Drug: Comparator: Placebo comparator

Study type: Interventional

Funder types: Industry

Identifiers

NCT00758680

1006-004

2008_550

Details and patient eligibility

About

This study will asses the safety, tolerability, multiple-dose pharmacokinetics and pharmacodynamics of MK1006 in participants with type 2 diabetes.

Enrollment: 112 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Participant has a BMI less than or equal to 42 kg/m^2 at the screening visit
• Participant has been diagnosed with Type 2 Diabetes that is being treated either by diet and exercise alone or by single or combination oral anti-hyperglycemic medications
• Participant is willing to follow a diet containing approximately 50% carbohydrates, 20% protein, and 30% fat during the study
• Participant is a nonsmoker and has not used nicotine containing products for ~ 6 months before start of study

Exclusion criteria

• Participant must not be treated with three or more oral anti-hyperglycemic medications, insulin, or PPAR-gamma agonists
• Participant has a history of stroke, chronic seizures, or a major neurological disorder
• Participant has had an eye infection or other inflammatory eye condition within 2 weeks of first dose of study drug
• Participant has glaucoma or is blind
• Participant has a condition known to be related to cataract development
• Participant has had or will have incisional eye surgery within 6 months before screening or has had laser surgery (other than Lasik) within 3 months of screening
• Participant has a history of type 1 diabetes or ketoacidosis
• Participant cannot stop taking certain current medications during the study
• Participant consumes greater than 3 alcoholic beverages per day
• Participant consumes more than 6 servings of caffeinated beverages per day (1 serving is ~ 120 mg caffeine)
• Participant has a history of significant multiple or severe allergies or has had a reaction to or is intolerant of prescription/non-prescription drugs or food
• Participant uses recreational drugs or has had a history of drug abuse within 6 months of start of study

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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112 participants in 10 patient groups, including a placebo group

MK-1006 20 mg Once Daily (Panel A)

Experimental group

Description:

After a 2-week run-in/wash-off period, participants received single daily doses (q.d.) of 20 mg MK-1006 over a 10-day multiple-dosing period while remaining domiciled in the Clinical Research Unit (CRU).

Treatment:

Drug: MK-1006

MK-1006 40 mg Once Daily (Panel B)

Experimental group

Description:

After a 2-week run-in/wash-off period, participants received single daily doses of 40 mg MK-1006 over a 10-day multiple-dosing period while remaining domiciled in the CRU.

Treatment:

Drug: MK-1006

MK-1006 80 mg Once Daily (Panel C)

Experimental group

Description:

After a 2-week run-in/wash-off period, participants received single daily doses of 80 mg MK-1006 over a 10-day multiple-dosing period while remaining domiciled in the CRU.

Treatment:

Drug: MK-1006

MK-1006 120 mg Once Daily (Panel D)

Experimental group

Description:

After a 2-week run-in/wash-off period, participants received single daily doses of 120 mg MK-1006 over a 10-day multiple-dosing period while remaining domiciled in the CRU.

Treatment:

Drug: MK-1006

MK-1006 20 mg Twice Daily (Panel E)

Experimental group

Description:

After a 2-week run-in/wash-off period, participants received twice-daily doses (b.i.d.) of 120 mg MK-1006 over a 10-day multiple-dosing period while remaining domiciled in the CRU.

Treatment:

Drug: MK-1006

MK-1006 30 mg Twice Daily (Panel F)

Experimental group

Description:

After a 2-week run-in/wash-off period, participants received twice-daily doses of 30 mg MK-1006 over a 10-day multiple-dosing period while remaining domiciled in the CRU.

Treatment:

Drug: MK-1006

MK-1006 50 mg Twice Daily (Panel G)

Experimental group

Description:

After a 2-week run-in/wash-off period, participants received twice-daily doses of 50 mg MK-1006 over a 10-day multiple-dosing period while remaining domiciled in the CRU.

Treatment:

Drug: MK-1006

MK-1006 120 mg Once Daily Outpatient (Panel H)

Experimental group

Description:

After a 2-week run-in/wash-off period, participants received single daily doses of 120 mg MK-1006 over a 7-day multiple-dosing period while remaining domiciled in the CRU. Participants were then discharged from the CRU and continued daily dosing of MK-1006 for an additional 21 days as outpatients.

Treatment:

Drug: MK-1006

MK-1006 50 mg Twice Daily Outpatient (Panel I)

Experimental group

Description:

After a 2-week run-in/wash-off period, participants received twice-daily doses of 50 mg MK-1006 over a 7-day multiple-dosing period while remaining domiciled in the CRU. Participants were then discharged from the CRU and continued daily dosing of MK-1006 for an additional 21 days as outpatients.

Treatment:

Drug: MK-1006

Placebo

Placebo Comparator group

Description:

After a 2-week run-in/wash-off period, participants received dose-matched placebo to MK-1006 over a multiple-dosing period while remaining domiciled in the CRU.

Treatment:

Drug: Comparator: Placebo comparator