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Trial from ANZCTR

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

  • Recruitment status at the time of last update
    Recruiting
  • What is the status of the ethics application?
    Ethics status: Approved
  • Prospective – trial registered prior to recruitment of first participant.

    Retrospective – trial registered after recruitment of first participant.
    Prospectively registered
  • Has the trial been updated in the last 12 months?
    Up to date
    (Last updated: 21/12/2017)
  • Ethics status: Approved
    What is the status of the ethics application?
  • Up to date
    Has the trial been updated in the last 6 months?
Key trial Information

Trial ID

ACTRN12615000913572

Date registered

02 September 2015

Health condition

Type 2 Diabetes

Recruitment countries

Australia

Recruitment site location(s) (State)

Northern Territory

Recruitment status

Recruiting

Anticipated date of first participant enrolment

04 January 2016

Ethics application status

Approved

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.

Eligibility

Key inclusion criteria

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

Minimum age

18 Years

Maximum age

No limit

Gender

Both males and females

Key exclusion criteria

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

Contact details and further information

Primary Sponsor

Type: Other
Name: BakerIDI Heart and Diabetes Institute
Address: 75 Commercial Rd Melbourne , VIC 3004
Country: Australia

Contact person for information and recruitment

A/Prof Neale Cohen
BakerIDI Heart and Diabetes Institute
Level 4, 99 Commercial Rd , Melbourne
VIC
3004
Australia
+61385321800
neale.cohen@bakeridi.edu.au