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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]

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

Cystic Fibrosis with Impaired Glucose Tolerance

Condition category

Condition code

Metabolic and Endocrine

Diabetes

Human Genetics and Inherited Disorders

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]

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]

Post prandial glycaemia measured as peak glucose and area under the curve for blood glucose at 240 minutes.

Timepoint [1]

4 hours after intervention or placebo

Secondary outcome [1]

Plasma concentration of glucagon-like peptide 1 (GLP-1)

Timepoint [1]

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]

Gastric half emptying time through measurement by 13C Na-octanoae breath test

Timepoint [2]

After intervention and eating pancake meal, 15 minutely for 2 hours then 30 minutely for 2 hours.

Secondary outcome [3]

Serum Glucose dependent insulinotropic polypeptide (GIP) assay

Timepoint [3]

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]

Plasma concentration of insulin

Timepoint [4]

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]

Plasma concentration of glucose

Timepoint [5]

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]

Plasma concentration of C-peptide

Timepoint [6]

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]

Plasma concentration of glucagon

Timepoint [7]

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]

Plasma concentration of free fatty acids

Timepoint [8]

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]

Plasma concentration of triglycerides

Timepoint [9]

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

Sex

Both males and females

Can healthy volunteers participate?

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

19/10/2015

Actual

16/03/2016

Date of last participant enrolment

Anticipated

Actual

16/02/2017

Date of last data collection

Anticipated

Actual

23/02/2017

Sample size

Target

Accrual to date

Final

Recruitment in Australia

Recruitment state(s)

Funding & Sponsors

Funding source category [1]

Charities/Societies/Foundations

Name [1]

The Channel 7 Children's Research Foundation of South Australia

Address [1]

PO Box 2438
Regency Park SA 5942

Country [1]

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]

University

Name [1]

University of Adelaide

Address [1]

North Terrace,
Adelaide
South Australia 5005

Country [1]

Australia

Secondary sponsor category [2]

Hospital

Name [2]

Women's and Children's Health Network

Address [2]

Women's and Children's Hospital
72 King William Road
North Adelaide
South Australia 5006

Country [2]

Australia

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Women's and Children's Health Network Human Research Ethics Committee

Ethics committee address [1]

Women's and Children's Hospital
Research Secretariat
72 King William Road
North Adelaide 5006
South Australia

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

Approval date [1]

15/04/2015

Ethics approval number [1]

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

Prof Jennifer Couper

Address

Endocrine Department
Women's and Children's Hospital
72 King William Road
North Adelaide
SA 5006

Country

Australia

Phone

+61 8 8161 6402

Fax

jennifer.couper@adelaide.edu.au

Contact person for public queries

Name

Myfanwy Geyer

Address

Endocrine Department
Women's and Children's Hospital
72 King William Road
North Adelaide
SA 5006

Country

Australia

Phone

+61 8 8161 6402

Fax

myfanwy.geyer@sa.gov.au

Contact person for scientific queries

Name

Myfanwy Geyer

Address

Endocrine Department
Women's and Children's Hospital
72 King William Road
North Adelaide
SA 5006

Country

Australia

Phone

+61 8 8161 6402

Fax

myfanwy.geyer@sa.gov.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

Source	Title	Year of Publication	DOI
Embase	Exenatide corrects postprandial hyperglycaemia in young people with cystic fibrosis and impaired glucose tolerance: A randomized crossover trial.	2019	https://dx.doi.org/10.1111/dom.13544

N.B. These documents automatically identified may not have been verified by the study sponsor.

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Documents added manually

Documents added automatically