A study of efficacy and safety of the glucose lowering drug Exenatide on patients with suspected acute stroke and hyperglycemia

Phase 1

• Conditions: Patients with hyperglycemia and symptoms of acute stroke will be randomized to either subcutaneous injection with 10ug of Byetta or standard care.; Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]

• Registration Number: EUCTR2011-002780-16-SE
• Lead Sponsor: Karolinska Institutet

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2012-04-03
• Last Update Posted: 23 May 2016

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

•Prehospitally clinically clearly suspected stroke and/or =1 point in the Cincinnati Prehospital Stroke Scale.
•Plasma glucose between 8,0-15,0 mmol/l, measured from capillary sample,
•Age = 18 years.
•Maximum of 6 h delay from onset of symptom to screening.
•Informed consent.

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 30
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 70

Exclusion Criteria

•Pregnancy
•Sever liver disease (known cirrhosis).
•Type 1 diabetes.
•On regular haemo- or peritoneal dialysis.
•Inability to adequately give informed consent due to pronounced aphasia.
•On-going treatment with Insulin, GLP-1 or DPP-4 based treatments.
•GCS < 14
•Clinically clearly suspected pharyngeal palsy
•GCS verbal score < 5
•Inability to make informed decisions

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified