Patients with hyperglycemia and symptoms of acute stroke will be randomized to either subcutaneous injection with 10ug of Byetta or standard care.
Conditions
Interventions
Trade Name: Byetta
Product Name: Byetta
Pharmaceutical Form: Solution for injection in pre-filled pen
INN or Proposed INN: EXENATIDE
CAS Number: 141758-74-9
Concentration unit: µg microgram(s)
Concent
Sponsors
Karolinska Institutet
Eligibility
Sex/Gender
All
Inclusion criteria
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
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary objective of this study is to investigate whether Exenatide given in a pre-hospital setting lowers blood glucose levels 4 h after injection, in patients with symptoms of a cerebrovascular lesion. ;Secondary Objective: To investigate the overall safety and tolerability of Exenatide during acute stroke, specifically hypoglycaemic episodes.;Primary end point(s): • The primary endpoint is lowering of plasma glucose with 2 mmol/L, 4 hours after 10µg exenatide injection.;Timepoint(s) of evaluation of this end point: 4 hours after injection of 10µg exenatide. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): • The incidence of nausea and vomiting • The incidence of hypoglycaemia, defined as an event with clinical symptoms that are considered to result from a hypoglycemic episode (i.e sweating, palpitations, hunger, restlessness, anxiety, fatigue, irritability, headache, loss of concentration, somnolence, psychiatric or visual disorders, transient sensory or motor defects, confusion, convulsions or coma) with an accompanying plasma glucose < 3.9 mmol/L. • Pulse and blood pressure, over time (measured every 4th hour). • Plasma markers of neuronal damage (i.e. S-100B, NSE). ) after 24 hours compared to baseline (0h). • Levels of plasma markers of inflammation (i.e. hs-CRP, IL-6, TNF-a and PAI-1) after 24 hours compared to baseline (0h). ;Timepoint(s) of evaluation of this end point: 24 hours after injection of 10µg exenatide. | — |
Countries
Sweden
Contacts
Public ContactDavid Nathanson
Karolinska Institutet Södersjukhuset
Outcome results
None listed