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

Phase 4

Completed

• Conditions: Type 2 Diabetes; Metabolic and Endocrine - Diabetes

• Registration Number: ACTRN12615000913572
• Lead Sponsor: BakerIDI Heart and Diabetes Institute

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2015-09-02
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 40

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Change in HbA1c measured at baseline and 4, 8, 12, 16, and 20 weeks. Measurement will use HPLC methodology [0, 4, 8, 12, 16, and 20 weeks ]

Secondary Outcome Measures

Name	Time	Method
Weight change on a measuring scale will be assessed at baseline and 4, 8, 12, 16, and 20 weeks.[0, 4, 8, 12, 16, and 20 weeks ];Urine albumin change [0, 4, 8, 12, 16, and 20 weeks ];Hypoglycaemia <br>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.[0, 4, 8, 12, 16, and 20 weeks ];Gastrointestinal side effects <br>Patient interviews will be performed including questions regarding symptoms of nausea and vomiting episodes at baseline and 4, 8, 12, 16, and 20 weeks.[0, 4, 8, 12, 16, and 20 weeks ];Blood pressure change <br>Blood pressure will be checked at baseline and 4, 8, 12, 16, and 20 weeks by the study nurse[0, 4, 8, 12, 16, and 20 weeks ]