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Trial registered on ANZCTR


Registration number
ACTRN12615000913572
Ethics application status
Approved
Date submitted
6/08/2015
Date registered
2/09/2015
Date last updated
17/12/2018
Date data sharing statement initially provided
17/12/2018
Type of registration
Prospectively registered

Titles & IDs
Public title
Exenatide -LAR in addition to standard care in Indigenous Australians with type 2 diabetes and effect on glycaemic control
Scientific title
A pilot study to investigate the efficacy, feasibility and safety of once weekly injection of exenatide-LAR in addition to standard diabetes care on blood glucose control in indigenous Australians with type 2 diabetes living in remote communities
Secondary ID [1] 287176 0
Nil
Universal Trial Number (UTN)
U1111-1172-7330
Trial acronym
LOWER-SUGAR: Long acting Once Weekly Exenatide laR-SUGAR study
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Type 2 Diabetes 295745 0
Condition category
Condition code
Metabolic and Endocrine 296023 296023 0 0
Diabetes

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Exenatide LAR 2 mg will be administered as a once weekly subcutaneous injection to indigenous people with diabetes in remote communities, in addition to their usual hypoglycemic therapy over a period of 20 weeks. The subcutaneous injection will be associated with usual care including weekly contact by a clinician. As the injections will take place in the clinic and administered by clinical staff, compliance will be determined according to the attendance records
Intervention code [1] 292515 0
Treatment: Drugs
Comparator / control treatment
The control group will have usual care including a once weekly clinic appointment for review of their diabetes management. Usual care will include management of diabetes according to local guidelines and the current practice of the clinical service in the community. The control group will be offered exenatide LAR 2 mg treatment for 20 weeks following the initial 20 week period
Control group
Active

Outcomes
Primary outcome [1] 295762 0
Change in HbA1c measured at baseline and 4, 8, 12, 16, and 20 weeks. Measurement will use HPLC methodology
Timepoint [1] 295762 0
0, 4, 8, 12, 16, and 20 weeks
Secondary outcome [1] 316454 0
Weight change on a measuring scale will be assessed at baseline and 4, 8, 12, 16, and 20 weeks.
Timepoint [1] 316454 0
0, 4, 8, 12, 16, and 20 weeks
Secondary outcome [2] 316455 0
Urine albumin change
Timepoint [2] 316455 0
0, 4, 8, 12, 16, and 20 weeks
Secondary outcome [3] 316456 0
Hypoglycaemia
Patients will receive blood glucose meters for self monitoring. Documented hypoglycaemia according to glucose readings as well as symptomatic hypoglycaemia according to patient interview will be assessed at at baseline and 4, 8, 12, 16, and 20 weeks.
Timepoint [3] 316456 0
0, 4, 8, 12, 16, and 20 weeks
Secondary outcome [4] 316457 0
Gastrointestinal side effects
Patient interviews will be performed including questions regarding symptoms of nausea and vomiting episodes at baseline and 4, 8, 12, 16, and 20 weeks.
Timepoint [4] 316457 0
0, 4, 8, 12, 16, and 20 weeks
Secondary outcome [5] 316458 0
Blood pressure change
Blood pressure will be checked at baseline and 4, 8, 12, 16, and 20 weeks by the study nurse
Timepoint [5] 316458 0
0, 4, 8, 12, 16, and 20 weeks

Eligibility
Key inclusion criteria
Indigenous Australians with T2DM, BMI > 25kg/m2 and HbA1c > 7.5%.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Pregnancy , childbearing potential, Type 1 diabetes, history of pancreatitis, history of heavy alcohol abuse, eGFR < 45 45ml/min/1.73m2

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)
This will be a cluster randomised controlled trial in which communities will be randomly allocated to either exenatide LAR or control arms
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Given the small number of communities involved there will be coin tossing for randomisation
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Other
Other design features
This study is a stepped wedge design. All participants will receive exenatide LAR however the control arm will receive standard care without exenatide LAR for the first 20 weeks, and subsequently receive exenatide LAR for the following 20 weeks. This is a stepped wedge design
Phase
Phase 4
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
4/01/2016
Actual
28/06/2016
Date of last participant enrolment
Anticipated
31/12/2017
Actual
31/12/2017
Date of last data collection
Anticipated
31/05/2018
Actual
29/06/2018
Sample size
Target
40
Accrual to date
Final
37
Recruitment in Australia
Recruitment state(s)
NT
Recruitment postcode(s) [1] 10071 0
0870 - Alice Springs

Funding & Sponsors
Funding source category [1] 291798 0
Commercial sector/Industry
Name [1] 291798 0
Astra Zeneca
Country [1] 291798 0
Australia
Primary sponsor type
Other
Name
BakerIDI Heart and Diabetes Institute
Address
75 Commercial Rd Melbourne , VIC 3004
Country
Australia
Secondary sponsor category [1] 290458 0
Commercial sector/Industry
Name [1] 290458 0
Astra Zeneca
Address [1] 290458 0
5 Alma Rd, North Ryde, NSW 2113
Country [1] 290458 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 293317 0
Central Australian Human Research Ethics Committee
Ethics committee address [1] 293317 0
PO Box 4066 Alice Springs NT 0871
Ethics committee country [1] 293317 0
Australia
Date submitted for ethics approval [1] 293317 0
01/10/2015
Approval date [1] 293317 0
21/03/2016
Ethics approval number [1] 293317 0

Summary
Brief summary
To demonstrate, as part of a pilot study, the feasibility and safety of a clinical trial to demonstrate the efficacy, safety and acceptability of a once weekly injection of exenatide LAR in addition to weekly clinical contact and otherwise usual care in Aboriginal Australians and/or Torres Strait Islanders (Indigenous Australians) with sub-optimally controlled type 2 diabetes.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 59154 0
A/Prof Neale Cohen
Address 59154 0
BakerIDI Heart and Diabetes Institute
Level 4, 99 Commercial Rd , Melbourne
VIC
3004
Country 59154 0
Australia
Phone 59154 0
+61385321800
Fax 59154 0
Email 59154 0
[email protected]
Contact person for public queries
Name 59155 0
Neale Cohen
Address 59155 0
BakerIDI Heart and Diabetes Institute
Level 4, 99 Commercial Rd , Melbourne
VIC
3004
Country 59155 0
Australia
Phone 59155 0
+61385321800
Fax 59155 0
Email 59155 0
[email protected]
Contact person for scientific queries
Name 59156 0
Neale Cohen
Address 59156 0
BakerIDI Heart and Diabetes Institute
Level 4, 99 Commercial Rd , Melbourne
VIC
3004
Country 59156 0
Australia
Phone 59156 0
+61385321800
Fax 59156 0
Email 59156 0
[email protected]

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


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
SourceTitleYear of PublicationDOI
Dimensions AIFeasibility of once weekly exenatide-LAR and enhanced diabetes care in Indigenous Australians with type 2 diabetes (Long-acting-Once-Weekly-Exenatide laR-SUGAR, ‘Lower SUGAR’ study)2021https://doi.org/10.1111/imj.15428
N.B. These documents automatically identified may not have been verified by the study sponsor.