Overview

A Study of the Effects of Co-Administration of Sitagliptin (MK-0431) and Metformin on Incretin Hormone Concentrations (MK-0431-110)

Status:
Completed
Trial end date:
2009-05-14
Target enrollment:
0
Participant gender:
All
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.
Phase:
Phase 1
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Merck Sharp & Dohme Corp.
Treatments:
Gastric Inhibitory Polypeptide
Hormones
Incretins
Metformin
Sitagliptin Phosphate
Criteria
Inclusion Criteria:

- 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 Criteria:

- 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