Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Exenatide · 3 trials · 4 indications
* cardiac chamber dimensions * left ventricular systolic function * left ventricular diastolic function * right ventricular systolic function
The percentage of time spent achieving blood glucose control is defined as the ratio between the total time spent achieving blood glucose control and the total time under treatment. Blood glucose measurement will be done hourly. Blood glucose control is considered to be achieved between 2 blood glucose measurements if the first blood glucose value measured belongs to blood glucose target interval, defined as blood glucose level between 100 mg/dl l and 140 mg/dl l.
The SF-36 score is a self-administered questionnaire that assess both the physical and the psychosocial health-related quality of life. The use of the SF-36 score is recommended by the French Health Authority in coronary patients. The variation of the SF-36 score value at 3-months is defined as the difference between the SF36-score value at 3 months minus the preoperative SF-36 score value.
| Arm | Type | Description |
|---|---|---|
| Exenatide | EXPERIMENTAL | Patients with decreased left ventricular function undergoing elective coronary artery by-pass grafting receiving perioperatively i.v. exenatide on top of standard treatment |
| Control | NO_INTERVENTION | Patients with decreased left ventricular function undergoing elective coronary artery by-pass grafting receiving standard treatment |
| Exenatide group | EXPERIMENTAL | Exenatide. Exenatide: bolus of 0.05 µg/min infused during the 1st hour of treatment, followed by a continuous infusion of 0.025 µg/min until the end of treatment. The exenatide therapy will begin as soon as a blood glucose level is above 140 mg/dl will be measured. A of exenatide will be intravenously . The treatment will be administrated during the first postoperative 48 hours in the intensive care unit or until intensive care unit discharge if this event occurs earlier. |
| Insulin group | ACTIVE_COMPARATOR | Insulin: Humalog (insulin lispro human analog). The insulin therapy will begin as soon as a blood glucose level is above 140 mg/dl will be measured. The dose of insulin intravenously infused will be adapted to blood glucose measurements, following the insulin therapy protocol used in our department. The insulin therapy protocol used in our department and prescribed as the benchmark treatment in the present study has been validated in a previous study. It has been derived from the protocol validated by Goldberg et al. |
| Name | Type | Description |
|---|---|---|
| Exenatide | DRUG | Perioperative continuous i.v. administration of exenatide lasting for 72 hours - 40 ng/min for initial 30 min, 20 ng/min for remaining 71.5 hours |
| Insulin | DRUG | - |
Inclusion Criteria: * elective coronary artery bypass grafting operation (CABG) * decreased left ventricular (LV) systolic function (EF LV ≤ 50%) * Age 18 to 85 * Signed informed consent * Females with childbearing potential have to use appropriate contraceptive measures during the whole study peri...
Exenatide is being studied for use in stress hyperglycemia, coronary artery disease, and quality of life in cardiac surgery patients. It is a small molecule in Phase 3 development for these cardiovascular-related conditions. The drug is being developed by Eli Lilly and Company.
Exenatide is a glucagon-like peptide 1 (GLP-1) agonist, as indicated in the clinical trial title. It targets the GLP-1 receptor to help improve glucose control and cardiac function in patients with coronary artery disease.
Exenatide is being developed by Eli Lilly and Company, which trades under the ticker LLY. The company is conducting clinical trials to evaluate the drug for stress hyperglycemia, coronary artery disease, and quality of life improvements.
Exenatide is in Phase 3 clinical development for stress hyperglycemia, coronary artery disease, and quality of life. It is an investigational drug and has not been approved by the FDA for these indications. The drug is still undergoing clinical trials.
Exenatide has been studied in three completed clinical trials: NCT01373216 for coronary artery disease and decreased left ventricular function, NCT01969149 for stress hyperglycemia, and NCT02432976 for quality of life in cardiac surgery patients. The trials were conducted in Czechia and France.
Exenatide is a type of GLP-1 agonist, as described in the clinical trial title. It is specifically a glucagon-like peptide 1 agonist, which means it mimics the action of the natural GLP-1 hormone to regulate glucose levels.