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

Type 2 Diabetes Mellitus Clinical Trial

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01144338
• Other study ID #: D5551C00003
• Secondary ID: MB001-002BCB109
• Status: Completed
• Phase: Phase 3
• Start date: June 18, 2010
• Est. completion date: April 24, 2017

Study information

• Verified date: July 2018
• Source: AstraZeneca
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 14752
• Est. completion date: April 24, 2017
• Est. primary completion date: April 21, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 130 Years

Eligibility

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.

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2
• Type 2 Diabetes Mellitus

Intervention

Drug:
• Exenatide Once Weekly
Subcutaneous injection, 2 mg, administered once weekly.
• Placebo
Subcutaneous injection, matching volume of placebo, administered once weekly.

Locations

Country	Name	City	State
Argentina	Research Site	Buenos Aires
Argentina	Research Site	Buenos Aires
Argentina	Research Site	Caba
Argentina	Research Site	Caba
Argentina	Research Site	Caba
Argentina	Research Site	Capital Federal
Argentina	Research Site	CiudadAutonoma De Buenos Aires
Argentina	Research Site	Cordoba
Argentina	Research Site	Cordoba
Argentina	Research Site	Cordoba
Argentina	Research Site	Cordoba
Argentina	Research Site	Godoy Cruz
Argentina	Research Site	Jujuy
Argentina	Research Site	Mar Del Plata Buenos Aires
Argentina	Research Site	Rosario
Argentina	Research Site	Salta
Argentina	Research Site	San Miguel de Tucuman
Argentina	Research Site	Santa Rosa
Australia	Research Site	Adelaide
Australia	Research Site	Camperdown
Australia	Research Site	Clayton
Australia	Research Site	East Gosford
Australia	Research Site	Elizabeth Vale
Australia	Research Site	Fitzroy
Australia	Research Site	Garran
Australia	Research Site	Geelong
Australia	Research Site	Heidelberg West
Australia	Research Site	Meadobank
Australia	Research Site	Milton
Australia	Research Site	Parkville
Australia	Research Site	Sydney
Austria	Research Site	Feldkirch
Austria	Research Site	Graz
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United States	Research Site	Toledo	Ohio
United States	Research Site	Torrance	California
United States	Research Site	Tustin	California
United States	Research Site	Victorville	California
United States	Research Site	Washington	District of Columbia
United States	Research Site	Webster	Texas
United States	Research Site	Wilmington	North Carolina
United States	Research Site	Winston-Salem	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
AstraZeneca

Countries where clinical trial is conducted

United States,  Argentina,  Australia,  Austria,  Belgium,  Brazil,  Bulgaria,  Canada,  Chile,  China,  Colombia,  Czechia,  Germany,  Hong Kong,  Hungary,  Israel,  Italy,  Korea, Republic of,  Latvia,  Lithuania,  Malaysia,  Mexico,  Netherlands,  New Zealand,  Philippines,  Poland,  Romania,  Russian Federation,  Slovakia,  South Africa,  Spain,  Taiwan,  Thailand,  Ukraine,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Primary Efficacy Outcome MACE Events	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.	Time to first event. Information collected during study period (anticipated to be up to 7.5 years).
Primary	Primary Safety Outcome MACE Events	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.	Time to first event. Information collected during study period (anticipated to be up to 7.5 years).
Secondary	Secondary Efficacy Outcome All-Cause Mortality	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.	Time to first event. Information collected during study period (anticipated to be up to 7.5 years).
Secondary	Secondary Efficacy Outcome CV Death	Component of the primary efficacy outcome: cardiovascular death. The number of participants who had an event is reported in the results.	Time to first event. Information collected during study period (anticipated to be up to 7.5 years).
Secondary	Secondary Efficacy Outcome MI	Component of primary efficacy outcome: fatal or non-fatal MI. The number of participants who had an event is reported in the results.	Time to first event. Information collected during study period (anticipated to be up to 7.5 years).
Secondary	Secondary Efficacy Outcome Stroke	Component of primary efficacy outcome: fatal or non-fatal stroke. The number of participants who had an event is reported in the results.	Time to first event. Information collected during study period (anticipated to be up to 7.5 years).
Secondary	Secondary Efficacy Outcome Hospitalization for ACS	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.	Time to first event. Information collected during study period (anticipated to be up to 7.5 years).
Secondary	Secondary Efficacy Outcome Hospitalization for HF	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.	Time to first event. Information collected during study period (anticipated to be up to 7.5 years).

External Links

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