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NCT Number: NCT01144338

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

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.

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Key information

Conditions

Type 2 Diabetes Mellitus Diabetes Mellitus Diabetes Mellitus, Type 2 Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year–130 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Research Site, Buenos Aires, Argentina

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

exenatide once weekly

Drug

Subcutaneous injection, 2 mg, administered once weekly.

Placebo

Drug

Subcutaneous injection, matching volume of placebo, administered once weekly.

Primary outcomes

  1. Primary Efficacy Outcome MACE Events

    Time frame: Time to first event. Information collected during study period (anticipated to be up to 7.5 years).

    The primary efficacy outcome variable is defined as the composite endpoint of cardiovascular death, nonfatal MI, or nonfatal stroke. The number of participants who had an event is reported in the results.

    The primary efficacy endpoint is the same as the primary safety endpoint, and the statistical analysis tests the superiority of exenatide against the placebo.

  2. Primary Safety Outcome MACE Events

    Time frame: Time to first event. Information collected during study period (anticipated to be up to 7.5 years).

    The primary safety outcome variable is defined as the composite endpoint of cardiovascular death, nonfatal MI, or nonfatal stroke. The number of participants who had an event is reported in the results.

    The primary safety endpoint is the same as the primary efficacy endpoints, and the statistical analysis tests the non-inferiority of exenatide against placebo.

Secondary outcomes

  1. Secondary Efficacy Outcome All-Cause Mortality

    Time frame: Time to first event. Information collected during study period (anticipated to be up to 7.5 years).

    The secondary efficacy outcome variable is defined as the all-cause mortality (deaths). The number of participants who had an event is reported in the results.

  2. Secondary Efficacy Outcome CV Death

    Time frame: Time to first event. Information collected during study period (anticipated to be up to 7.5 years).

    Component of the primary efficacy outcome: cardiovascular death. The number of participants who had an event is reported in the results.

  3. Secondary Efficacy Outcome MI

    Time frame: Time to first event. Information collected during study period (anticipated to be up to 7.5 years).

    Component of primary efficacy outcome: fatal or non-fatal MI. The number of participants who had an event is reported in the results.

  4. Secondary Efficacy Outcome Stroke

    Time frame: Time to first event. Information collected during study period (anticipated to be up to 7.5 years).

    Component of primary efficacy outcome: fatal or non-fatal stroke. The number of participants who had an event is reported in the results.

  5. Secondary Efficacy Outcome Hospitalization for ACS

    Time frame: Time to first event. Information collected during study period (anticipated to be up to 7.5 years).

    The secondary efficacy outcome variable is defined as hospitalization for acute coronary syndrome. The number of participants who had an event is reported in the results.

  6. Secondary Efficacy Outcome Hospitalization for HF

    Time frame: Time to first event. Information collected during study period (anticipated to be up to 7.5 years).

    The secondary efficacy outcome variable is defined as hospitalization for heart failure. The number of participants who had an event is reported in the results.

Sponsors and collaborators

Lead sponsor

AstraZeneca

Industry

Registry information

Official study title

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.

Important dates

Study start
2010
Primary completion
2017
Study completion
2017
First posted
Jun 15, 2010
Registry last updated
Aug 8, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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