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Trial registered on ANZCTR


Registration number
ACTRN12615001029583
Ethics application status
Approved
Date submitted
17/08/2015
Date registered
1/10/2015
Date last updated
26/07/2018
Type of registration
Prospectively registered

Titles & IDs
Public title
Does exenatide improve post prandial glycaemic control in young people with cystic fibrosis related diabetes or impaired glucose tolerance?
Scientific title
The use of exenatide, a GLP-1 agonist, in young people with cystic fibrosis related diabetes and impaired glucose tolerance in the management of post prandial glycaemia, gastric emptying and incretins.
Secondary ID [1] 287279 0
Nil known
Universal Trial Number (UTN)
U1111-1173-2876
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Cystic Fibrosis Related Diabetes 295916 0
Cystic Fibrosis with Impaired Glucose Tolerance 295917 0
Condition category
Condition code
Metabolic and Endocrine 296167 296167 0 0
Diabetes
Human Genetics and Inherited Disorders 296168 296168 0 0
Cystic fibrosis

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Double blind cross-over single dose study.

The intervention is exenatide, 2.5 micrograms, subcutaneously administered 15 minutes prior to the commencement of a pancake meal.

Exenatide is a clear fluid, identical to the placebo (0.9% normal saline).

There will be 2 study days with at least 2 days between start times.

The medication will be administered on the study day by the researcher. The pancake will be prepared and provided on the study day by the researcher.
Intervention code [1] 292589 0
Treatment: Drugs
Comparator / control treatment
Placebo will contain 0.9% normal saline in the same volume as the intervention.
Control group
Placebo

Outcomes
Primary outcome [1] 295841 0
Post prandial glycaemia measured as peak glucose and area under the curve for blood glucose at 240 minutes.
Timepoint [1] 295841 0
4 hours after intervention or placebo
Secondary outcome [1] 316707 0
Plasma concentration of glucagon-like peptide 1 (GLP-1)
Timepoint [1] 316707 0
Prior to administration of intervention, then after eating the pancake meal at timepoints (minutes) +15, +30, +45, +60, +90, +120, +150, +180 and +240.
Secondary outcome [2] 316708 0
Gastric half emptying time through measurement by 13C Na-octanoae breath test
Timepoint [2] 316708 0
After intervention and eating pancake meal, 15 minutely for 2 hours then 30 minutely for 2 hours.
Secondary outcome [3] 316926 0
Serum Glucose dependent insulinotropic polypeptide (GIP) assay
Timepoint [3] 316926 0
Prior to administration of intervention, then after eating the pancake meal at timepoints (minutes) +15, +30, +45, +60, +90, +120, +150, +180 and +240.
Secondary outcome [4] 316927 0
Plasma concentration of insulin
Timepoint [4] 316927 0
Prior to administration of intervention, then after eating the pancake meal at timepoints (minutes) +15, +30, +45, +60, +90, +120, +150, +180 and +240.
Secondary outcome [5] 316928 0
Plasma concentration of glucose
Timepoint [5] 316928 0
Prior to administration of intervention, then after eating the pancake meal at timepoints (minutes) +15, +30, +45, +60, +90, +120, +150, +180 and +240.
Secondary outcome [6] 316929 0
Plasma concentration of C-peptide
Timepoint [6] 316929 0
Prior to administration of intervention, then after eating the pancake meal at timepoints (minutes) +15, +30, +45, +60, +90, +120, +150, +180 and +240.
Secondary outcome [7] 316930 0
Plasma concentration of glucagon
Timepoint [7] 316930 0
Prior to administration of intervention, then after eating the pancake meal at timepoints (minutes) +15, +30, +45, +60, +90, +120, +150, +180 and +240.
Secondary outcome [8] 316931 0
Plasma concentration of free fatty acids
Timepoint [8] 316931 0
Prior to administration of intervention, then after eating the pancake meal at timepoints (minutes) +15, +30, +45, +60, +90, +120, +150, +180 and +240.
Secondary outcome [9] 316932 0
Plasma concentration of triglycerides
Timepoint [9] 316932 0
Prior to administration of intervention, then after eating the pancake meal at timepoints (minutes) +15, +30, +45, +60, +90, +120, +150, +180 and +240.

Eligibility
Key inclusion criteria
Male or Female patients aged 10-25 years with cystic fibrosis with exocrine pancreatic insufficiency taking pancreatic enzymes.
WITH
Cystic Fibrosis Related Diabetes (CFRD) (2 hour glucose on routine OGTT >11.1 mmol/L),
OR CFRD without fasting hyperglycaemia,
OR Cystic Fibrosis with Impaired Glucose Tolerance (CF with IGT) (2 hour glucose >7.8mmol/L<11.1mmol/L)
Minimum age
10 Years
Maximum age
25 Years
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Severe pulmonary disease (FEV1 <30% predicted)
Significant liver disease (Child-Pugh score >6)
Requirement for medications that could affect gastrointestinal motility (eg. erythromycin, SSRI)
Severe renal impairment
Previous stomach or small bowel surgery
Pregnancy or lactation

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)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Crossover
Other design features
Phase
Phase 3
Type of endpoint(s)
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
SA

Funding & Sponsors
Funding source category [1] 291844 0
Charities/Societies/Foundations
Name [1] 291844 0
The Channel 7 Children's Research Foundation of South Australia
Address [1] 291844 0
PO Box 2438
Regency Park SA 5942
Country [1] 291844 0
Australia
Primary sponsor type
Individual
Name
Jennifer Couper
Address
Paediatric Endocrine Department
Women's and Children's Hospital
72 King William Road
North Adelaide
SA 5006
Country
Australia
Secondary sponsor category [1] 290512 0
University
Name [1] 290512 0
University of Adelaide
Address [1] 290512 0
North Terrace,
Adelaide
South Australia 5005
Country [1] 290512 0
Australia
Secondary sponsor category [2] 290567 0
Hospital
Name [2] 290567 0
Women's and Children's Health Network
Address [2] 290567 0
Women's and Children's Hospital
72 King William Road
North Adelaide
South Australia 5006
Country [2] 290567 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 293360 0
Women's and Children's Health Network Human Research Ethics Committee
Ethics committee address [1] 293360 0
Women's and Children's Hospital
Research Secretariat
72 King William Road
North Adelaide 5006
South Australia
Ethics committee country [1] 293360 0
Australia
Date submitted for ethics approval [1] 293360 0
Approval date [1] 293360 0
15/04/2015
Ethics approval number [1] 293360 0
HREC/13/WCHN/116

Summary
Brief summary
Aim to evaluate the effect of exenatide on postprandial glycaemia in patients with cystic fibrosis related diabetes (CFRD) and impaired glucose tolerance (IGT). CFRD has a detrimental impact on pulmonary function, mortality and prognosis after lung transplant, that is currently treated by intensive insulin regimen. GLP-1 is released in response to food ingestion and is known to stimulate insulin secretion, suppress glucagon secretion and slow gastric emptying. Exenatide is a GLP-1 (glucagon-like peptide 1) agonist that can be administered daily without significant risk of hypoglycaemia. It is anticipated that exenatide will normalise postprandial glycaemia.

This is a double blinded crossover trial where participants will have 2 study days. On the first day they will receive the intervention or placebo, receiving the opposite on the second day. Once the intervention or placebo has been given, the participant will consume a pancake followed by assessment of glycaemia, incretin response and gastric emptying.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 59542 0
Prof Jennifer Couper
Address 59542 0
Endocrine Department
Women's and Children's Hospital
72 King William Road
North Adelaide
SA 5006
Country 59542 0
Australia
Phone 59542 0
+61 8 8161 6402
Fax 59542 0
Email 59542 0
jennifer.couper@adelaide.edu.au
Contact person for public queries
Name 59543 0
Dr Myfanwy Geyer
Address 59543 0
Endocrine Department
Women's and Children's Hospital
72 King William Road
North Adelaide
SA 5006
Country 59543 0
Australia
Phone 59543 0
+61 8 8161 6402
Fax 59543 0
Email 59543 0
myfanwy.geyer@sa.gov.au
Contact person for scientific queries
Name 59544 0
Dr Myfanwy Geyer
Address 59544 0
Endocrine Department
Women's and Children's Hospital
72 King William Road
North Adelaide
SA 5006
Country 59544 0
Australia
Phone 59544 0
+61 8 8161 6402
Fax 59544 0
Email 59544 0
myfanwy.geyer@sa.gov.au

No information has been provided regarding IPD availability
Summary results
Have study results been published in a peer-reviewed journal?
Other publications
Have study results been made publicly available in another format?
Results – basic reporting
Results – plain English summary