Overview

This trial is active, not recruiting.

Condition type 2 diabetes mellitus
Treatments exenatide once weekly, placebo
Phase phase 3
Sponsor AstraZeneca
Start date June 2010
End date April 2018
Trial size 14000 participants
Trial identifier NCT01144338, BCB109, D5551C00003, MB001-002

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking double blind (subject, investigator, outcomes assessor)
Primary purpose treatment
Arm
(Experimental)
exenatide once weekly
Subcutaneous injection, 2 mg, administered once weekly.
(Placebo Comparator)
placebo
Subcutaneous injection, matching volume of placebo, administered once weekly.

Primary Outcomes

Measure
The primary efficacy outcome variable is defined as the composite endpoint of cardiovascular death, nonfatal MI, or nonfatal stroke
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.
time frame: Time to first event. Information collected during study period (anticipated to be up to 7.5 years).

Secondary Outcomes

Measure
All-cause mortality
time frame: Time to event. Information collected during study period (anticipated to be up to 7.5 years).
Components of the primary composite endpoint (cardiovascular death, fatal or nonfatal MI, fatal or nonfatal stroke).
time frame: Time to first event. Information collected during study period (anticipated to be up to 7.5 years).
Hospitalization for acute coronary syndrome
time frame: Time to first event. Information collected during study period (anticipated to be up to 7.5 years).
Hospitalization for heart failure
time frame: Time to first event. Information collected during study period (anticipated to be up to 7.5 years).

Eligibility Criteria

Male or female participants from 18 years up to 130 years old.

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.

Additional Information

Official 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.
Trial information was received from ClinicalTrials.gov and was last updated in January 2016.
Information provided to ClinicalTrials.gov by AstraZeneca.