Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12608000428369
Ethics application status
Approved
Date submitted
11/08/2008
Date registered
26/08/2008
Date last updated
19/01/2015
Type of registration
Prospectively registered

Titles & IDs
Public title
The effect of the glucagon-like peptide-1 analogue, exenatide, on duodenal motility and flow events, and small intestinal transit in healthy humans and type 2 diabetes mellitus.
Scientific title
The effect of the glucagon-like peptide-1 analogue, exenatide, on duodenal motility and flow events, and small intestinal transit in healthy humans and type 2 diabetes mellitus.
Secondary ID [1] 283532 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Type 2 diabetes 3535 0
Small intestinal motility 3536 0
Glucose absorption 3610 0
Condition category
Condition code
Metabolic and Endocrine 3689 3689 0 0
Diabetes
Oral and Gastrointestinal 3690 3690 0 0
Normal oral and gastrointestinal development and function
Metabolic and Endocrine 3768 3768 0 0
Diabetes

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Each subject will be studied on 2 occasions in a double-blind, randomised crossover design, separated by at least 3 days. On both days, subjects will receive an intraduodenal glucose infusion at a rate of 3 kcal/min from t = 0 to 60 min. On one day, an intravenous (IV) infusion of exenatide will be administered (50 ng/min between t = -30 to 0 min, then 25 ng/min between 0 and 240 min). On the other day, IV saline 0.9% will be administered between t = -30 and 240 min) .
Intervention code [1] 3249 0
Treatment: Drugs
Comparator / control treatment
IV 0.9% saline; appearance identical to exenatide infusion.
Control group
Placebo

Outcomes
Primary outcome [1] 4597 0
Frequency of duodenal pressure waves and flow events, measured by manometry and impedance
Timepoint [1] 4597 0
15 min periods from t = 0 to 240 min
Primary outcome [2] 4598 0
Small intestinal transit, measured by scintigraphy
Timepoint [2] 4598 0
Every 15 min from 0 to 60 min, then every 30 min from 60 to 240 min
Secondary outcome [1] 7757 0
Absorption of the glucose analog, 3-O-methylglucose (3-OMG), as assessed by plasma concentrations of 3-OMG
Timepoint [1] 7757 0
t = 0, 10, 20, 30, 40, 50, 60, 90, 120, 180, and 240 min

Eligibility
Key inclusion criteria
Healthy subjects:
1. Body mass index (BMI) 19 - 25 kg/m2
Type 2 diabetic patients:
1. Body mass index (BMI) 19 - 35 kg/m2
2. Type 2 diabetes (World Health Organisation (WHO) criteria) managed by diet alone (i.e no oral hypoglycaemic drugs or insulin)
Minimum age
18 Years
Maximum age
70 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
History of gastrointestinal surgery (except appendicectomy)
1. Medication which may affect gastrointestinal motor function, specifically: opiates, anticholinergics, levodopa, calcium-channel antagonists, beta blockers, clonidine, nitrates, tricyclic antidepressants, selective serotonin re-uptake inhibitors, phosphodiesterase type 5 inhibitors, sumatriptan, metoclopramide, domperidone, cisapride, tegaserod, erythromycin
2. Other significant illness, including epilepsy, cardiovascular or respiratory disease
3. Pregnancy or lactation
4. Evidence of drug abuse, consumption of more than 20 g alcohol or 10 cigarettes per day
5. Regular gastrointestinal symptoms (as assessed by a validated upper gastrointestinal symptom questionnaire)
6. Autonomic nerve damage (as assessed by standardised cardiovascular reflex tests)

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)
Sealed opaque envelopes
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Computer-generated random number table
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Crossover
Other design features
Phase
Phase 1
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
15/09/2008
Actual
5/12/2008
Date of last participant enrolment
Anticipated
Actual
28/03/2014
Date of last data collection
Anticipated
Actual
Sample size
Target
24
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 3716 0
Commercial sector/Industry
Name [1] 3716 0
Eli Lilly Australia
Country [1] 3716 0
Australia
Primary sponsor type
Hospital
Name
Royal Adelaide Hospital
Address
Royal Adelaide Hospital, North Terrace, Adelaide SA 5000
Country
Australia
Secondary sponsor category [1] 3333 0
None
Name [1] 3333 0
Address [1] 3333 0
Country [1] 3333 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 5771 0
Royal Adelaide Hospital Human Research Ethics Committee
Ethics committee address [1] 5771 0
Ethics committee country [1] 5771 0
Australia
Date submitted for ethics approval [1] 5771 0
Approval date [1] 5771 0
10/04/2008
Ethics approval number [1] 5771 0
080210a

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 28828 0
A/Prof Chris Rayner
Address 28828 0
Discipline of Medicine Royal Adelaide Hospital North Terrace Adelaide SA 5000
Country 28828 0
Australia
Phone 28828 0
+61 8 82222916
Fax 28828 0
Email 28828 0
[email protected]
Contact person for public queries
Name 11985 0
A/Prof Chris Rayner
Address 11985 0
Discipline of Medicine
Royal Adelaide Hospital
North Terrace
Adelaide SA 5000
Country 11985 0
Australia
Phone 11985 0
08 8222 2916
Fax 11985 0
08 8223 3870
Email 11985 0
[email protected]
Contact person for scientific queries
Name 2913 0
A/Prof Chris Rayner
Address 2913 0
Discipline of Medicine
Royal Adelaide Hospital
North Terrace
Adelaide SA 5000
Country 2913 0
Australia
Phone 2913 0
08 8222 2916
Fax 2913 0
08 8223 3870
Email 2913 0
[email protected]

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.