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