Short-Term Exenatide Therapy in Acute Ischaemic Stroke - A Randomised, Open-Label, Parallel-Group Study

Not Applicable

Completed

• Conditions: Metabolic and Endocrine - Diabetes; Hyperglycaemia; Diabetes; Acute Ischaemic Stroke; Stroke - Ischaemic

• Registration Number: ACTRN12614001189617
• Lead Sponsor: orthern Sydney Local Health District

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2014-11-12
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

Patient presenting with acute ischaemic stroke, as confirmed by routine neurological assessment
- Blood glucose level > 10mmol/L on blood glucose testing during the first 72 hours after admission to the Acute Stroke Ward
- Age > 18 years

Exclusion Criteria

- Type 1 diabetes mellitus
- Initial NIHSS > 20
- Life expectancy below 12 months
- Pre morbid modified Rankin Score above 3
- Impaired liver function, defined as alanine aminotransferase (ALT) > 3 times the upper limit of normal
- Impaired renal function, defined as eGFR < 30 ml/min/1.73m2
- History of pancreatitis
- History of pancreatic cancer
- History of medullary thyroid cancer or multiple endocrine neoplasia II
- Known allergy to exenatide
- Suspected or known abuse of alcohol or narcotics
- Pregnancy or lactation

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Blood glucose levels within target range within the first 24 hours after commencing exenatide treatment. The target range of blood glucose levels is 5 - 10mmol/L.[24 hours];Determining the frequency and duration of hypoglycaemia in participants receiving exenatide versus insulin therapy. Hypoglycaemia is defined as a blood glucose level < 4mmol/L.[72 hours.];Feasability of exenatide administration in the setting of acute ischaemic stroke. This will be assessed through the use of a clinical staff survey that will compare the difficulty of use of IV exenatide vs. insulin, as well as assessing the time and resources required for both therapies.[72 hours.]

Secondary Outcome Measures

Name	Time	Method
Change in National Institutes of Health Stroke Scale (NIHSS) from baseline, 24 hours, 3 days and 3 months.[24 hours, 72 hours, 3 months.];Modified Rankin Scale rating at 3 months.[3 months.];Safety and tolerability of exenatide therapy in patients with acute ischaemic stroke. Safety will be assessed by determining the number of episode of hypoglycaemia in the exenatide arm. Furthermore, the incidence of adverse events, specifically gastrointestinal side effects in the exenatide arm, will be evaluated.[72 hours.]