Phase 3
Completed N=14,752
Exenatide Study of Cardiovascular Event Lowering Trial (EXSCEL): A Trial To Evaluate Cardiovascular Outcomes After Treatment With Exenatide Once Weekly In Patients With Type 2 Diabetes Mellitus
Source: ClinicalTrials.gov NCT01144338 ↗Enrolled (actual)
14,752
Serious AEs
16.7%
Results posted
Aug 2018
Primary outcomePrimary: Primary Efficacy Outcome MACE Events — 905; 839 Participants — p=0.061
◆ Published Evidence
Established
25citations · ~13 / year
Inflammatory proteins associated with Alzheimer's disease reduced by a GLP1 receptor agonist: a post hoc analysis of the EXSCEL randomized placebo controlled trial.
Summary
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.
Linked Publications (5)
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Inflammatory proteins associated with Alzheimer's disease reduced by a GLP1 receptor agonist: a post hoc analysis of the EXSCEL randomized placebo controlled trial.
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Glucagon-like peptide 1 (GLP-1) receptor agonists for people with chronic kidney disease and diabetes.
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Effect of race on cardiometabolic responses to once-weekly exenatide: insights from the Exenatide Study of Cardiovascular Event Lowering (EXSCEL).
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Estimated glomerular filtration rate slope and risk of primary and secondary major adverse cardiovascular events and heart failure hospitalization in people with type 2 diabetes: An analysis of the EXSCEL trial.
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Estimating Risk Factor Time Paths Among People with Type 2 Diabetes and QALY Gains from Risk Factor Management.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Primary Efficacy Outcome MACE Events |
905; 839 | 0.061 |
| PRIMARY Primary Safety Outcome MACE Events |
905; 839 | < 0.001 sig |
| SECONDARY Secondary Efficacy Outcome All-Cause Mortality |
584; 507 | 0.016 sig |
| SECONDARY Secondary Efficacy Outcome CV Death |
383; 340 | 0.096 |
| SECONDARY Secondary Efficacy Outcome MI |
493; 483 | 0.622 |
| SECONDARY Secondary Efficacy Outcome Stroke |
218; 187 | 0.095 |
| SECONDARY Secondary Efficacy Outcome Hospitalization for ACS |
570; 602 | 0.402 |
| SECONDARY Secondary Efficacy Outcome Hospitalization for HF |
231; 219 | 0.485 |
Eligibility Criteria
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 40 ng/L at baseline.
Data sourced from ClinicalTrials.gov (NCT01144338) and the linked publication. Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.