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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 | Clinical Trials | Clareo Health

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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

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.

NCT01144338•AstraZeneca

View on ClinicalTrials.gov

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.

Eligibility

Age

18 - 130 years

Sex

ALL

Healthy Volunteers

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.

Locations (629)

Research Site

Birmingham, Alabama, United States

Research Site

Glendale, Arizona, United States

Research Site

Phoenix, Arizona, United States

Research Site

Jonesboro, Arkansas, United States

Research Site

Little Rock, Arkansas, United States

Research Site

Chula Vista, California, United States

Research Site

Concord, California, United States

Research Site

Escondido, California, United States

Research Site

Fullerton, California, United States

Research Site

Greenbrae, California, United States

Key Dates

Start Date

June 18, 2010

Primary Completion Date

April 21, 2017

Completion Date

April 24, 2017

Last Updated

August 8, 2018

Enrollment

14,752

ACTUAL participants

Conditions

Type 2 Diabetes Mellitus

Interventions

Exenatide Once Weekly

DRUG

Placebo

DRUG

Feasibility of a Tailored Online Self-compassion Intervention

NCT07051005

Type 1 Diabetes MellitusType 2 Diabetes Mellitus (T2DM)

View study

RECRUITINGNA

Achieving Routine Intervention and Screening for Emotional Health

NCT06887049

Type 2 Diabetes Mellitus (T2DM)Diabetes Distress

View study

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: August 8, 2018Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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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

Inclusion Criteria

Exclusion Criteria

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