Phase 3 · Exenatide

NCT01144338 trial results

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.

Participants
14,752
Status
completed
Completed
2017-04-24
Sponsor
AstraZeneca

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.

Primary outcome

What NCT01144338 measured first

Primary Efficacy Outcome MACE EventsParticipants · Time to first event. Information collected during study period (anticipated to be up to 7.5 years). · count of participants
MeasurePlacebon=7,396Exenatide Once Weeklyn=7,356
Number of patients who had a MACE event905839
Primary Safety Outcome MACE EventsParticipants · Time to first event. Information collected during study period (anticipated to be up to 7.5 years). · count of participants
MeasurePlacebon=7,396Exenatide Once Weeklyn=7,356
Number of patients who had a MACE event905839
Secondary outcomes

What else it measured

Secondary Efficacy Outcome All-Cause MortalityParticipants · Time to first event. Information collected during study period (anticipated to be up to 7.5 years). · count of participants
MeasurePlacebon=7,396Exenatide Once Weeklyn=7,356
Number of patients who died584507
Secondary Efficacy Outcome CV DeathParticipants · Time to first event. Information collected during study period (anticipated to be up to 7.5 years). · count of participants
MeasurePlacebon=7,396Exenatide Once Weeklyn=7,356
Number of patients who had CV death383340
Secondary Efficacy Outcome MIParticipants · Time to first event. Information collected during study period (anticipated to be up to 7.5 years). · count of participants
MeasurePlacebon=7,396Exenatide Once Weeklyn=7,356
Number of patients who died493483
Secondary Efficacy Outcome StrokeParticipants · Time to first event. Information collected during study period (anticipated to be up to 7.5 years). · count of participants
MeasurePlacebon=7,396Exenatide Once Weeklyn=7,356
Number of patients who had stroke218187
Secondary Efficacy Outcome Hospitalization for ACSParticipants · Time to first event. Information collected during study period (anticipated to be up to 7.5 years). · count of participants
MeasurePlacebon=7,396Exenatide Once Weeklyn=7,356
Num of pts with hospitalization due to ACS570602
Secondary Efficacy Outcome Hospitalization for HFParticipants · Time to first event. Information collected during study period (anticipated to be up to 7.5 years). · count of participants
MeasurePlacebon=7,396Exenatide Once Weeklyn=7,356
Number of patients who died231219
The trial

How NCT01144338 was run

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.

  • Exenatide Once Weekly
  • Placebo
Who could join the trial

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.

Published papers

Papers from NCT01144338

Trial averages do not predict what one person will experience. Results are shown as the registry posts them, without interpretation.

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