What NCT01144338 measured first
| Measure | Placebon=7,396 | Exenatide Once Weeklyn=7,356 |
|---|---|---|
| Number of patients who had a MACE event | 905 | 839 |
| Measure | Placebon=7,396 | Exenatide Once Weeklyn=7,356 |
|---|---|---|
| Number of patients who had a MACE event | 905 | 839 |
Exenatide Study of Cardiovascular Event Lowering Trial (EXSCEL). A Randomized, Placebo Controlled Clinical Trial to Evaluate Cardiovascular Outcomes After Treatment With Exenatide Once Weekly in Patients With Type 2 Diabetes Mellitus.
Primary Efficacy Outcome MACE Events (Participants), Time to first event. Information collected during study period (anticipated to be up to 7.5 years).. Placebo: 905; Exenatide Once Weekly: 839.
As posted on ClinicalTrials.gov (NCT01144338), updated at source Aug 8, 2018. Read again whenever the registry updates it. Registry figures can differ from a published paper, which may use another analysis.
| Measure | Placebon=7,396 | Exenatide Once Weeklyn=7,356 |
|---|---|---|
| Number of patients who had a MACE event | 905 | 839 |
| Measure | Placebon=7,396 | Exenatide Once Weeklyn=7,356 |
|---|---|---|
| Number of patients who had a MACE event | 905 | 839 |
| Measure | Placebon=7,396 | Exenatide Once Weeklyn=7,356 |
|---|---|---|
| Number of patients who died | 584 | 507 |
| Measure | Placebon=7,396 | Exenatide Once Weeklyn=7,356 |
|---|---|---|
| Number of patients who had CV death | 383 | 340 |
| Measure | Placebon=7,396 | Exenatide Once Weeklyn=7,356 |
|---|---|---|
| Number of patients who died | 493 | 483 |
| Measure | Placebon=7,396 | Exenatide Once Weeklyn=7,356 |
|---|---|---|
| Number of patients who had stroke | 218 | 187 |
| Measure | Placebon=7,396 | Exenatide Once Weeklyn=7,356 |
|---|---|---|
| Num of pts with hospitalization due to ACS | 570 | 602 |
| Measure | Placebon=7,396 | Exenatide Once Weeklyn=7,356 |
|---|---|---|
| Number of patients who died | 231 | 219 |
This study will compare the impact of including exenatide once weekly in addition to usual care vs. usual care without exenatide on major cardiovascular outcomes as measured by the primary composite endpoint of cardiovascular-related death, nonfatal myocardial infarction (MI), or nonfatal stroke.
Inclusion Criteria: * Patient has type 2 diabetes mellitus * Patient has an HbA1c of ≥ 6.5 % and ≤ 10.0% and is currently using one of the following treatment regimens: A) Treatment with 0-3 oral antihyperglycemic agents B) Insulin therapy, either alone or in combination with up to two oral agents * Female patients must not be breast feeding and agree to use an effective method of contraception or must not otherwise be at risk of becoming pregnant. Exclusion Criteria: * Patient has a diagnosis of type 1 diabetes mellitus, or a history of ketoacidosis. * Patient has ever been treated with an approved or investigational GLP-1 receptor agonist. * Patient is enrolled in another experimental protocol which involves the use of an investigational drug or device, or an intervention that would interfere with the conduct of the trial. * Patient has a planned or anticipated revascularization procedure. * Pregnancy or planned pregnancy during the trial period. * Patient has end-stage renal disease or an estimated glomerular filtration rate (eGFR) of \<30 mL/min/1.73m2. * Patient has a history of gastroparesis or pancreatitis. * Personal or family history of medullary thyroid cancer or MEN2 (Multiple EndocrineNeoplasia Type 2) or calcitonin level of \>40 ng/L at baseline.
Trial averages do not predict what one person will experience. Results are shown as the registry posts them, without interpretation.