Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12607000378426
Ethics application status
Approved
Date submitted
13/07/2007
Date registered
18/07/2007
Date last updated
18/07/2007
Type of registration
Retrospectively registered

Titles & IDs
Public title
Effects of sitagliptin on gastric emptying in healthy subjects.
Scientific title
Effects of sitagliptin on gastric emptying in healthy subjects.
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Gastric emptying 1959 0
Condition category
Condition code
Oral and Gastrointestinal 2055 2055 0 0
Normal oral and gastrointestinal development and function

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
sitagliptin 100mg, oral, once daily for 2 days
Study is a crossover design with a washout period of 5 - 14 days (dependent on equipment scheduling)
Intervention code [1] 1838 0
Treatment: Drugs
Comparator / control treatment
placebo, oral, once daily for 2 days. Placebo tablets will be identical in taste, size and colour to sitagliptin tablets. Study is a crossover design with a washout period of 5 - 14 days (dependent on equipment scheduling)
Control group
Placebo

Outcomes
Primary outcome [1] 2882 0
Gastric emptying rate
Timepoint [1] 2882 0
At 15 minute intervals from 0 - 150 minutes, 30 minutes intervals from 150 - 240 minutes.
Primary outcome [2] 2883 0
GLP-1 levels
Timepoint [2] 2883 0
At -2 minutes, 15 minute intervals from 0 - 120 minutes, 30 minute intervals from 120 - 240 minutes.
Secondary outcome [1] 4863 0
Intragastric Distribution
Timepoint [1] 4863 0
15 min intervals from 0 - 150 mins, 30 min intervals from 150 - 240 mins
Secondary outcome [2] 4864 0
Glycaemia, Insulinaemia and Gastro Intestinal (GI) Hormones
Timepoint [2] 4864 0
-2 mins, 15 minute intervals from 0 - 120 mins, 30 min intervals from 120 - 240 mins
Secondary outcome [3] 4865 0
Appetite
Timepoint [3] 4865 0
-2 mins, 15 minute intervals from 0 - 120 mins, 30 min intervals from 120 - 240 mins

Eligibility
Key inclusion criteria
Body Mass Index (BMI) 19-25 kg/m2
Minimum age
18 Years
Maximum age
45 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
GI diseaseAlcohol >20g dailyCigarettes >10 per dayPregnant or lactating femalesMedication known to influence GI functionCalculated Creatinine Clearance <60ml/minSubjects exposed to ionising radiation in previous 12 months.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
numbered containers
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
random number table using computer program
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Crossover
Other design features
Subjects, Clinicians and outcome assessors will all be blinded in the study. Code will be broken only for final statistical analysis.
Phase
Phase 1
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
15/06/2007
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
15
Accrual to date
Final

Funding & Sponsors
Funding source category [1] 2199 0
Commercial sector/Industry
Name [1] 2199 0
Merck Sharpe & Dohme
Country [1] 2199 0
Australia
Primary sponsor type
Hospital
Name
Royal Adelaide Hospital
Address
Country
Australia
Secondary sponsor category [1] 1986 0
None
Name [1] 1986 0
nil
Address [1] 1986 0
Country [1] 1986 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 3997 0
Royal Adelaide Hospital Human Research Ethics Committee
Ethics committee address [1] 3997 0
Ethics committee country [1] 3997 0
Australia
Date submitted for ethics approval [1] 3997 0
Approval date [1] 3997 0
02/01/2007
Ethics approval number [1] 3997 0
061025

Summary
Brief summary
This purpose of this study is to evaluate the effect of sitagliptin on gastric emptying, intragastric meal distribution, postprandial glycaemia and insulinaemia in healthy subjects. Glucagon-like peptide-1 (GLP-1) inhibits gastric emptying, thereby slowing the delivery of nutrients, and their absorption, across the small intestine. The rate of entry of carbohydrate into the small intestine is especially important in patients with diabetes. Sitagliptin is an orally administered inhibitor of dipeptidyl-peptidase-IV (DPP-IV), the enzyme responsible for the degradation of GLP-1. It is hypothesised that sitagliptin will increase the GLP-1 response to, and thereby slow gastric emptying and diminish the glycaemic response to, a carbohydrate-containing meal.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 27652 0
Address 27652 0
Country 27652 0
Phone 27652 0
Fax 27652 0
Email 27652 0
Contact person for public queries
Name 11027 0
Dr Karen Jones
Address 11027 0
Discipline of Medicine
Level 6, Eleanor Harrald Building
Royal Adelaide Hospital
North Terrace ADELAIDE SA 5000
Country 11027 0
Australia
Phone 11027 0
08 8222 5394
Fax 11027 0
08 8223 3870
Email 11027 0
karen.jones@adelaide.edu.au
Contact person for scientific queries
Name 1955 0
Dr Karen Jones
Address 1955 0
Level 6
Eleanor Harrald Building
Royal Adelaide Hospital
North Terrace
Adelaide SA 5000
Country 1955 0
Australia
Phone 1955 0
08 8222 5394
Fax 1955 0
08 8223 3870
Email 1955 0
karen.jones@adelaide.edu.au

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.