LivingGLP1
Study S000905

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.

Included trial: extracted dataClinicalTrials.gov recordStudy Protocol (PDF)Statistical Analysis Plan (PDF)

Registration

Registration
NCT01144338
Study type
INTERVENTIONAL
Allocation
RANDOMIZED
Phase
PHASE3
Masking
TRIPLE
Status
COMPLETED
Enrollment
14752
Start
2010-06-18
Primary completion
2017-04-21
Lead sponsor
AstraZeneca
Conditions
Type 2 Diabetes Mellitus
Interventions
DRUG:Exenatide Once Weekly; DRUG:Placebo
Results posted
TRUE
Secondary identifiers
OTHER:MB001-002; OTHER:BCB109

Registered primary outcomes

  • Primary Efficacy Outcome MACE Events [Time to first event. Information collected during study period (anticipated to be up to 7.5 years).]
  • Primary Safety Outcome MACE Events [Time to first event. Information collected during study period (anticipated to be up to 7.5 years).]

Linked records (26)

Automatic links, confirmed or rejected during screening. A record citing this registration may be a secondary analysis, a commentary or a review that mentions the trial.
RecordTitleYearDesignIdentifiersLink basis
R0003552Type 2 diabetes risk alleles in peptidyl-glycine alpha-amidating monooxygenase influence GLP-1 levels and response to GLP-1 receptor agonists.
Umapathysivam MM, Genome medicine
2026Other trialPMID 41906117DOIcites ClinicalTrials.gov:NCT01144338; registry reference DERIVED:41906117
R0010237Glucagon-like peptide 1 (GLP-1) receptor agonists for people with chronic kidney disease and diabetes.
Natale P, The Cochrane database of systematic reviews
2025Systematic reviewPMID 39963952DOIcites ClinicalTrials.gov:NCT01144338; registry reference DERIVED:39963952
R0006444Inflammatory proteins associated with Alzheimer's disease reduced by a GLP1 receptor agonist: a post hoc analysis of the EXSCEL randomized placebo controlled trial.
Koychev I, Alzheimer's research & therapy
2024Randomized trialPMID 39358806DOIcites ClinicalTrials.gov:NCT01144338; registry reference DERIVED:39358806
R0022497Estimated 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.
Oulhaj A, Diabetes, obesity & metabolism
2024Other trialPMID 39086032DOIcites ClinicalTrials.gov:NCT01144338; registry reference DERIVED:39086032
R0023223Effect of race on cardiometabolic responses to once-weekly exenatide: insights from the Exenatide Study of Cardiovascular Event Lowering (EXSCEL).
Davis TME, Cardiovascular diabetology
2022Randomized trialPMID 35761271DOIcites ClinicalTrials.gov:NCT01144338; registry reference DERIVED:35761271
R0023721Lifetime cost-effectiveness simulation of once-weekly exenatide in type 2 diabetes: A cost-utility analysis based on the EXSCEL trial.
Becker F, Diabetes research and clinical practice
2022Other trialPMID 34813910DOIcites ClinicalTrials.gov:NCT01144338; registry reference DERIVED:34813910
R0011561Exploring the Possible Impact of Unbalanced Open-Label Drop-In of Glucose-Lowering Medications on EXSCEL Outcomes.
Bethel MA, Circulation
2020Randomized trialPMID 32098501DOIcites ClinicalTrials.gov:NCT01144338; registry reference DERIVED:32098501
R0024676Within-Trial Evaluation of Medical Resources, Costs, and Quality of Life Among Patients With Type 2 Diabetes Participating in the Exenatide Study of Cardiovascular Event Lowering (EXSCEL).
Reed SD, Diabetes care
2020Randomized trialPMID 31806653DOIcites ClinicalTrials.gov:NCT01144338; registry reference DERIVED:31806653
R0026410Confirming the Bidirectional Nature of the Association Between Severe Hypoglycemic and Cardiovascular Events in Type 2 Diabetes: Insights From EXSCEL.
Standl E, Diabetes care
2020OtherPMID 31882409DOIcites ClinicalTrials.gov:NCT01144338; registry reference DERIVED:31882409
R0043197Rationale and design of the EXenatide Study of Cardiovascular Event Lowering (EXSCEL) trial
H. Sourij, Carolina Digital Repository (University of North Carolina at Chapel Hill)
2020ProtocolDOIcites ClinicalTrials.gov:NCT01144338
R0043208Effects of exenatide and open-label SGLT2 inhibitor treatment, given in parallel or sequentially, on mortality and cardiovascular and renal outcomes in type 2 diabetes: Insights from the EXSCEL trial
L.E. Clegg, Carolina Digital Repository (University of North Carolina at Chapel Hill)
2020Nonrandomized studyDOIcites ClinicalTrials.gov:NCT01144338
R0043256Exploring the Possible Impact of Unbalanced Open-Label Drop-In of Glucose-Lowering Medications on EXSCEL Outcomes
R.A. Patel, Carolina Digital Repository (University of North Carolina at Chapel Hill)
2020Randomized trialDOIcites ClinicalTrials.gov:NCT01144338
R0043304Clinical Outcomes in Patients with Type 2 Diabetes Mellitus and Peripheral Artery Disease: Results from the EXSCEL Trial
Goodman, S.G., Carolina Digital Repository (University of North Carolina at Chapel Hill)
2020Other trialDOIcites ClinicalTrials.gov:NCT01144338
R0043331Baseline characteristics of patients enrolled in the Exenatide Study of Cardiovascular Event Lowering (EXSCEL)
N. Iqbal, Carolina Digital Repository (University of North Carolina at Chapel Hill)
2020Randomized trialDOIcites ClinicalTrials.gov:NCT01144338
R0011710Effects of exenatide and open-label SGLT2 inhibitor treatment, given in parallel or sequentially, on mortality and cardiovascular and renal outcomes in type 2 diabetes: insights from the EXSCEL trial.
Clegg LE, Cardiovascular diabetology
2019Nonrandomized studyPMID 31640705DOIcites ClinicalTrials.gov:NCT01144338; registry reference DERIVED:31640705
R0012707Clinical Outcomes in Patients With Type 2 Diabetes Mellitus and Peripheral Artery Disease: Results From the EXSCEL Trial.
Badjatiya A, Circulation. Cardiovascular interventions
2019Other trialPMID 31752517DOIcites ClinicalTrials.gov:NCT01144338; registry reference DERIVED:31752517
R0013006Changes in Serum Calcitonin Concentrations, Incidence of Medullary Thyroid Carcinoma, and Impact of Routine Calcitonin Concentration Monitoring in the EXenatide Study of Cardiovascular Event Lowering (EXSCEL).
Bethel MA, Diabetes care
2019Randomized trialPMID 31010875DOIcites ClinicalTrials.gov:NCT01144338; registry reference DERIVED:31010875
R0025136Effect of Once-Weekly Exenatide in Patients With Type 2 Diabetes Mellitus With and Without Heart Failure and Heart Failure-Related Outcomes: Insights From the EXSCEL Trial.
Fudim M, Circulation
2019Randomized trialPMID 31542942DOIcites ClinicalTrials.gov:NCT01144338; registry reference DERIVED:31542942
R0007117Generalizability of glucagon-like peptide-1 receptor agonist cardiovascular outcome trials enrollment criteria to the US type 2 diabetes population.
Wittbrodt ET, The American journal of managed care
2018Nonrandomized studyPMID 29693361cites ClinicalTrials.gov:NCT01144338; registry reference DERIVED:29693361
R0025316Effect of Once-Weekly Exenatide on Clinical Outcomes According to Baseline Risk in Patients With Type 2 Diabetes Mellitus: Insights From the EXSCEL Trial.
Mentz RJ, Journal of the American Heart Association
2018Other trialPMID 30371301DOIcites ClinicalTrials.gov:NCT01144338; registry reference DERIVED:30371301
R0049736Implications of cardiovascular outcome trials with injectable antidiabetic agents
Richard E. Pratley, Journal of Diabetes
2018Randomized trialPMID 29971941DOIcites ClinicalTrials.gov:NCT01144338
R0012723Baseline characteristics of patients enrolled in the Exenatide Study of Cardiovascular Event Lowering (EXSCEL).
Mentz RJ, American heart journal
2017Randomized trialPMID 28454792DOIcites ClinicalTrials.gov:NCT01144338; registry reference DERIVED:28454792
R0025311Effects of Once-Weekly Exenatide on Cardiovascular Outcomes in Type 2 Diabetes.
Holman RR, The New England journal of medicine
2017Randomized trialPMID 28910237DOIcites ClinicalTrials.gov:NCT01144338; registry reference DERIVED:28910237
R0043293The emergence of cardiodiabetology
Paul D. Rosenblit, Cardiovascular Endocrinology
2017Randomized trialPMID 31646112DOIcites ClinicalTrials.gov:NCT01144338
R0014969Rationale and design of the EXenatide Study of Cardiovascular Event Lowering (EXSCEL) trial.
Holman RR, American heart journal
2016ProtocolPMID 26995376DOIcites ClinicalTrials.gov:NCT01144338; registry reference DERIVED:26995376
R0025674Health and economic outcomes for exenatide once weekly, insulin, and pioglitazone therapies in the treatment of type 2 diabetes: a simulation analysis.
Gaebler JA, Vascular health and risk management
2012Other trialPMID 22566747DOIcites ClinicalTrials.gov:NCT01144338; registry reference DERIVED:22566747