Acute Ischemic Stroke
Conditions
Interventions
Experimental group:Beinaglutide
Control group:Routine stroke treatment
Sponsors
Peking University First Hospital
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1.Age =18 years old; 2.Acute ischemic stroke, regardless of history of diabetes; 3.Not suitable for intravenous thrombolysis or endovascular treatment within 24 hours of onset; 4.NIHSS score 3-22 (for recurrent stroke patients: 3-7 requires mRS Score 0 before the onset; The mRS Score before the onset was 0-1 in patients with 8-22 points). 5. Blood glucose at admission: 16.7 mmol/L= random blood glucose value =10 mmol/L; * Blood glucose must be measured twice or more and the vaules are within this range (at any time interval), with at least one measurement for venous blood glucose; 6. Informed consent was obtained before any trial-related activities.The participants were willing and able to cooperate with the trial procedures of scheduled visits, treatment planning, and laboratory testing.
Exclusion criteria
Exclusion criteria: 1.Patients with other types of diabetes except type 2 diabetes at screening; 2.Patients with diabetic ketoacidosis; 3.Life expectancy is less than 12 months; 4.History or family history of multiple endocrine neoplasia, type 2 (MEN 2); 5.History or family history of medullary thyroid carcinoma; 6.History of acute or chronic pancreatitis; 7.Severe dyslipidemia: TG =500 mg/dL (5.7 mmol/L) at screening; 8.Amylase or lipase =3 × ULN at screening; 9.Patients with definite history of malignant tumor; 10.Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) or total bilirubin =3 times the upper limit of normal value (ULN) at screening; 11.Renal impairment at screening, defined as a serum creatinine level =1.5 mg/dL (132 µmol/L) in men or =1.4 mg/dL (123 µmol/L) in women; 12.A past history of severe heart disease that meets one of the following criteria: A. a diagnosis of decompensated cardiac dysfunction (New York Heart Association [NYHA] class III-IV); b. Diagnosis of unstable angina pectoris; c. Myocardial infarction was diagnosed; 13. Untreated or poorly controlled hypertension (systolic blood pressure =160 mmHg and/or diastolic blood pressure =100 mmHg); 14.Participated in other drug clinical trials 3 months before screening; 15. Recipients who are known to be allergic or intolerant to beinaglutide or insulin; 16.Women who are pregnant or planning to become pregnant or being lactating; 17.A history of substance abuse within 6 months prior to screening and/or a history of alcohol abuse within 6 months; 18.The subject is unable to meet certain protocol requirements (e.g., use of subcutaneous pump, undergo MRI examination, insulin infusion, attend regular follow-up visits, the subject is unable to fully understand and complete the subject's study documents, etc.); 19.The investigator considers that the subject has any factors (medical, psychological, social or geographical factors) that may affect the efficacy and safety evaluation of the study or prevent him from successfully participating in the study; 20.Other conditions considered by the investigator to be ineligible for inclusion in the trial.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Proportion of patients with mRS Score = 3 at 90th day;During the treatment period, the proportion of each group within the target range of blood glucose within the target range of more than 70% and no hypoglycemia (<3.9 mmol/L) was within the average 24 hours of treatment.; | — |
Secondary
| Measure | Time frame |
|---|---|
| The proportion of patients with an mRS score of = 3 at discharge;Change in NIHSS score at discharge: improvement in NIHSS score by more than 4 points at 2 weeks or the proportion of patients with NIHSS 0-1.;Number of occurrences of hypoglycemia (less than 3.9 mmol/L);;The proportion of TIR (range 3.9~10.0mmol/L) (>70%) in the two groups (24h, during hospitalization).;status of new infarction and hemorrhagic within 14 days;status of new infarction and hemorrhagic within 90 days;Plasma lipid metabolism profile;Biomarkers associated with plasma nerve damage;All adverse events and adverse reactions that occurred during treatment;Hypoglycemic events; | — |
Countries
China
Contacts
Public ContactZhaoxia Wang
Peking University First Hospital
Outcome results
None listed