Effects of Sitagliptin on Gastric Emptying in Healthy Subjects

• Status: Completed
• Trial end date: 2011-12-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to determine the effects of the drug, sitagliptin, on the rate at which the stomach empties, and the release of gut hormones and blood glucose concentrations, after a mashed potato meal in healthy subjects. Sitagliptin has been shown to reduce the blood glucose (sugar) response to a meal and this may potentially be due to slowing of stomach emptying. This is particularly relevant to people who have diabetes, in whom normalization of elevated blood glucose levels is important to maintain health.

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Royal Adelaide Hospital
• Collaborator: Merck Sharp & Dohme Corp.
• Treatments: Sitagliptin Phosphate

Criteria

Inclusion Criteria:

• Male or female (females must be using an appropriate contraceptive method)

• 18 - 45 years

• Body mass index (BMI) 19 - 25 kg/m2.

Exclusion criteria:

• Subjects with gastrointestinal disease, history of gastrointestinal surgery and/or significant gastrointestinal symptoms

• Subjects taking medication known to influence gastrointestinal function

• Alcohol intake > 20 g per day

• Smoking > 10 cigarettes per day

• Pregnant and/or lactating females

• Calculated creatinine clearance < 60 ml/min

• Exposure to ionising radiation for research purposes in the previous 12 months.