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Trial registered on ANZCTR


Registration number
ACTRN12622001506785
Ethics application status
Approved
Date submitted
21/02/2022
Date registered
2/12/2022
Date last updated
2/12/2022
Date data sharing statement initially provided
2/12/2022
Type of registration
Retrospectively registered

Titles & IDs
Public title
Do short acting glucagon-like receptor agonists (GLP-1 RAs) attenuate the acceleration of gastric emptying induced by hypoglycaemia in type 2 diabetes?
Scientific title
Do short acting glucagon-like receptor agonists (GLP-1 RAs) attenuate the 'gastric' counter-regulatory response to hypoglycaemia in type 2 diabetes?
Secondary ID [1] 306489 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Diabetes 325353 0
Condition category
Condition code
Metabolic and Endocrine 322737 322737 0 0
Diabetes

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Short acting GLP-1 receptor agonist, exenatide twice daily OR placebo
a) exenatide dose 10microgram twice daily
b) duration of administration: 4 weeks - drug and 4 weeks - placebo
c) Mode of administration - subcutaneous injection
d) monitoring adherence - frequent phone calls during trial period to ensure compliance, checking the number of injections left when participant attends study day at the end of each 4 week period.
Intervention code [1] 322916 0
Treatment: Drugs
Comparator / control treatment
The placebo vial contains normal saline only. Placebo vial prepared by the Royal Adelaide Hospital Pharmacy specifically for this trial.
Control group
Placebo

Outcomes
Primary outcome [1] 330540 0
The primary outcome will be the change in the gastric emptying between hypoglycaemia and euglycaemia after 4 weeks treatment with exenatide BID vs Placebo treatment for 4 weeks.
Gastric emptying will be assessed by scintigraphy (gamma camera) - this is the gold standard technique.
Timepoint [1] 330540 0
Gastric emptying T100 (T100 is the gastric retention at 100 minutes)

Gastric emptying will be assessed 4 times i.e 4 separate days in total (twice after 4 weeks of exenatide treatment and twice after 4 weeks of placebo) during the trial
Secondary outcome [1] 406566 0
The secondary outcomes will be differences in plasma catecholamines between hypoglycaemia and euglycaemia study days
Timepoint [1] 406566 0
Plasma catecholamine will be measured at t = -15, 15, 30, 75, 90, 120, 150, and 180 min during the clamp studies.
The clamp studies will occur 4 times in total (twice after 4 weeks of exenatide treatment and twice after 4 weeks of placebo) during the trial
Secondary outcome [2] 416324 0
The additional secondary outcomes will be differences in plasma 3-OMG between hypoglycaemia and euglycaemia study days
Timepoint [2] 416324 0
Plasma 3-OMG will be measured at t = -15, 15, 30, 75, 90, 120, 150, and 180 min during the clamp studies.
The clamp studies will occur 4 times in total (twice after 4 weeks of exenatide treatment and twice after 4 weeks of placebo) during the trial

Eligibility
Key inclusion criteria
• Men and women with type 2 diabetes either diet controlled or metformin alone
• Aged 40 - 70 years
• Body Mass Index 20-40 kg/m²
• HbA1c less than or equal to 8.5 %
Minimum age
40 Years
Maximum age
70 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
• History of type 1 diabetes or on medications other than metformin
• HbA1c >8.5 %
• History of gastrointestinal disease, including known gastroparesis, peptic ulcer disease, significant upper or lower gastrointestinal symptoms, or previous gastrointestinal surgery (other than uncomplicated appendicectomy or cholecystectomy) or a history of migraine or panic attacks.
• Other significant illness, including epilepsy, cardiovascular or respiratory disease.
• Impaired renal function (as assessed by calculated creatinine clearance < 50 mL/min using the Cockcroft-Gault equation) or if iron stores or liver function tests are outside the following normal ranges:
- Alanine aminotransferase (ALT) < 110 U/L
- Alkaline phosphatase (ALP) 30 - 110 U/L
- Aspartate transaminase (AST) < 90 U/L
- Total bilirubin 2 - 24 µmol/L
- Haemoglobin 130 – 180 g/L (Males)
- Haemoglobin 115 – 155 g/L (Females)
- Ferritin > 30 µg/L (Males)
- Ferritin > 15 µg/L
(Females)
• Requirement for medication known to influence gastrointestinal function, (e.g. prokinetic drugs [metoclopramide, domperidone, erythromycin], antiemetics [ondansetron], antidiarrhoeals [loperamide], H2 receptor antagonists [ranitidine], drugs with substantial anticholinergic effects [amitriptyline, doxepin, dothiepin, mirtazapine, haloperidol, chlorpromazine, risperidone, oxybutynin], opioids [morphine, oxycodone, codeine], orlistat.
• Evidence of drug or alcohol abuse, or consumption of more than 20 g alcohol or 10 cigarettes on a daily basis.
• Vegetarian
• Donation of blood within the previous 3 months
• Participation in any other research studies within the previous 3 months
• Previous exposure to radiation for research purposes in the preceding 12 months
• Inability to give informed consent
• Positive pregnancy status or lactating (breast-feeding) female
• Contra-indication to use of exenatide
• A known history of intolerance or unwilling to self-inject exenatide

Study design
Purpose of the study
Prevention
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
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
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
Recruitment hospital [1] 21793 0
The Royal Adelaide Hospital - Adelaide
Recruitment postcode(s) [1] 36850 0
5000 - Adelaide

Funding & Sponsors
Funding source category [1] 310835 0
Hospital
Name [1] 310835 0
RAH Clinical Grants
Country [1] 310835 0
Australia
Primary sponsor type
Hospital
Name
Royal Adelaide Hospital
Address
Royal Adelaide Hospital, Port Rd, Adelaide SA 5005
Country
Australia
Secondary sponsor category [1] 312089 0
None
Name [1] 312089 0
none
Address [1] 312089 0
none
Country [1] 312089 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 310400 0
CALHN Human Research Ethics Committee
Ethics committee address [1] 310400 0
Ethics committee country [1] 310400 0
Australia
Date submitted for ethics approval [1] 310400 0
Approval date [1] 310400 0
15/01/2020
Ethics approval number [1] 310400 0

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

Contacts
Principal investigator
Name 117526 0
Dr Chinmay Marathe
Address 117526 0
Work Organisation: University of Adelaide
Level 5, AHMS Building, North Terrace, Adelaide SA 5000
Country 117526 0
Australia
Phone 117526 0
+61 431266075
Fax 117526 0
Email 117526 0
chinmay.marathe@adelaide.edu.au
Contact person for public queries
Name 117527 0
Chinmay Marathe
Address 117527 0
Work Organisation: University of Adelaide
Level 5, AHMS Building, North Terrace, Adelaide SA 5000
Country 117527 0
Australia
Phone 117527 0
+61 431266075
Fax 117527 0
Email 117527 0
chinmay.marathe@adelaide.edu.au
Contact person for scientific queries
Name 117528 0
Chinmay Marathe
Address 117528 0
Work Organisation: University of Adelaide
Level 5, AHMS Building, North Terrace, Adelaide SA 5000
Country 117528 0
Australia
Phone 117528 0
+61 431266075
Fax 117528 0
Email 117528 0
chinmay.marathe@adelaide.edu.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
15181Ethical approval    383617-(Uploaded-21-02-2022-13-28-42)-Study-related document.pdf
15183Informed consent form    383617-(Uploaded-21-02-2022-13-34-26)-Study-related document.pdf



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.