Status:
TERMINATED
A Multiple-Dose Study of MK-1006 (MK-1006-004)(TERMINATED)
Lead Sponsor:
Merck Sharp & Dohme LLC
Conditions:
Type 2 Diabetes
Eligibility:
All Genders
18-65 years
Phase:
PHASE1
Brief Summary
This study will asses the safety, tolerability, multiple-dose pharmacokinetics and pharmacodynamics of MK1006 in participants with type 2 diabetes.
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
August 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2010
Estimated Enrollment :
112 Patients enrolled
Trial Details
Trial ID
NCT00758680
Start Date
August 1 2008
End Date
March 1 2010
Last Update
February 5 2016
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