Status:
COMPLETED
A Study of the Effects of Co-Administration of Sitagliptin (MK-0431) and Metformin on Incretin Hormone Concentrations (MK-0431-110)
Lead Sponsor:
Merck Sharp & Dohme LLC
Conditions:
Type 2 Diabetes Mellitus
Eligibility:
All Genders
18-65 years
Phase:
PHASE1
Brief Summary
This study will assess the effects of sitagliptin and metformin alone and after co-administration on incretin hormone concentrations in patients with Type 2 diabetes.
Eligibility Criteria
Inclusion
- Female subjects must have a negative pregnancy test
- Subject has type 2 diabetes and is not currently receiving treatment with an oral AHA agent, has not received such treatment for 3 months prior to study, and/or has not received more than 4 total weeks treatment with an oral AHA agent for 12 to 18 months prior to the study
- Subject is a nonsmoker or has not smoked and/or used nicotine for at least 6 months
Exclusion
- Subject has a history of stroke, seizures, or major neurological disorders
- Female subject is breastfeeding
- Subject cannot refrain from use of any prescription or non-prescription drugs beginning 2 weeks prior to first dose of study drug
- Subject consumes more than 3 alcoholic beverages per day
- Subject consumes more than 6 caffeinated beverages per day
- Subject has had major surgery, or has donated or lost 1 unit of blood within 4 weeks of screening
- Subject has a history of cancer, except certain skin or cervical cancer or other cancers treated more than 10 years prior to screening
- Subject has a history of multiple and/or severe allergies or intolerance to drugs or food
Key Trial Info
Start Date :
December 2 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 14 2009
Estimated Enrollment :
18 Patients enrolled
Trial Details
Trial ID
NCT00830076
Start Date
December 2 2008
End Date
May 14 2009
Last Update
May 15 2017
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