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Trial details imported from

For full trial details, please see the original record at

Registration number
Ethics application status
Date submitted
Date registered
Date last updated

Titles & IDs
Public title
Effects of Sitagliptin on Gastric Emptying in Healthy Subjects
Scientific title
Effects of Sitagliptin on Gastric Emptying in Healthy Subjects
Secondary ID [1] 0 0
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Gastroparesis 0 0
Diabetes Mellitus 0 0
Condition category
Condition code
Oral and Gastrointestinal 0 0 0 0
Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon
Neurological 0 0 0 0
Other neurological disorders

Study type
Description of intervention(s) / exposure
Treatment: Drugs - Sitagliptin
Treatment: Drugs - Placebo

Experimental: Sitagliptin (100mg) - Active drug (sitagliptin)

Placebo Comparator: Placebo (sugar pill) - Inactive drug (placebo)

Treatment: Drugs: Sitagliptin
100mg mane for 2 days

Treatment: Drugs: Placebo
100mg mane for 2 days

Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Primary outcome [1] 0 0
Gastric emptying rate
Timepoint [1] 0 0
4 hours per study
Secondary outcome [1] 0 0
Intragastric distribution, gastrointestinal hormone release (GLP-1, GIP), glycemia, insulinemia, appetite
Timepoint [1] 0 0
4 hours per study

Key inclusion criteria
- Male or female (females must be using an appropriate contraceptive method)

- 18 - 45 years

- Body mass index (BMI) 19 - 25 kg/m2.
Minimum age
18 Years
Maximum age
45 Years
Both males and females
Can healthy volunteers participate?
Key exclusion criteria
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.

Study design
Purpose of the study
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s

The people analysing the results/data
Intervention assignment
Other design features
Phase 1
Type of endpoint(s)
Statistical methods / analysis

Recruitment status
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Date of last participant enrolment
Date of last data collection
Sample size
Accrual to date
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
Discipline of Medicine, Royal Adelaide Hospital - Adelaide
Recruitment postcode(s) [1] 0 0
5000 - Adelaide

Funding & Sponsors
Primary sponsor type
Royal Adelaide Hospital
Other collaborator category [1] 0 0
Commercial sector/Industry
Name [1] 0 0
Merck Sharp & Dohme Corp.
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

Brief 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.
Trial website
Trial related presentations / publications
Public notes

Principal investigator
Name 0 0
Karen L Jones, PhD
Address 0 0
University of Adelaide, Royal Adelaide Hospital
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Summary results
Other publications