Exenatide -LAR in addition to standard care in Indigenous Australians with type 2 diabetes and effect on glycaemic control

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

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ANZCTR

Registry ID

ACTRN12615000913572

Acronym

LOWER-SUGAR: Long acting Once Weekly Exenatide laR-SUGAR study

Enrollment

Registered

2015-09-02

Start date

2016-06-28

Completion date

2017-12-31

Last updated

2020-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

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.

Interventions

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

Study design

Allocation

Randomised controlled trial

Intervention model

Other

Primary purpose

Treatment

Masking

Open (masking not used)

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

Indigenous Australians with T2DM, BMI > 25kg/m2 and HbA1c > 7.5%.

Exclusion criteria

Pregnancy , childbearing potential, Type 1 diabetes, history of pancreatitis, history of heavy alcohol abuse, eGFR < 45 45ml/min/1.73m2

Outcome results