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 is currently recruiting participants. (see Contacts and Locations)
Verified August 2015 by AstraZeneca
Sponsor:
Information provided by (Responsible Party):
AstraZeneca
ClinicalTrials.gov Identifier:
NCT01144338
First received: June 10, 2010
Last updated: August 12, 2015
Last verified: August 2015
  Purpose

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.


Condition Intervention Phase
Type 2 Diabetes Mellitus
Drug: Exenatide Once Weekly
Drug: Placebo
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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.

Resource links provided by NLM:


Further study details as provided by AstraZeneca:

Primary Outcome Measures:
  • 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). ] [ Designated as safety issue: No ]
  • 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). ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • All-cause mortality [ Time Frame: Time to event. Information collected during study period (anticipated to be up to 7.5 years). ] [ Designated as safety issue: No ]
  • 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). ] [ Designated as safety issue: No ]
  • Hospitalization for acute coronary syndrome [ Time Frame: Time to first event. Information collected during study period (anticipated to be up to 7.5 years). ] [ Designated as safety issue: No ]
  • Hospitalization for heart failure [ Time Frame: Time to first event. Information collected during study period (anticipated to be up to 7.5 years). ] [ Designated as safety issue: No ]

Estimated Enrollment: 14000
Study Start Date: June 2010
Estimated Study Completion Date: April 2018
Estimated Primary Completion Date: April 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Exenatide Once Weekly Drug: Exenatide Once Weekly
Subcutaneous injection, 2 mg, administered once weekly.
Placebo Comparator: Placebo Drug: Placebo
Subcutaneous injection, matching volume of placebo, administered once weekly.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01144338

Contacts
Contact: AstraZeneca Clinical Study Information Center 1-877-240-9479 information.center@astrazeneca.com

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Locations
United States, Alabama
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Research Site Active, not recruiting
Vilnius, Lithuania
Malaysia
Research Site Active, not recruiting
Alor Setar, Malaysia
Research Site Active, not recruiting
Batu Caves, Malaysia
Research Site Active, not recruiting
Kota Samarahan, Malaysia
Research Site Active, not recruiting
Kuala Lumpur, Malaysia
Research Site Active, not recruiting
Kuching, Malaysia
Research Site Active, not recruiting
Sungai Buloh, Malaysia
Research Site Active, not recruiting
Taiping, Malaysia
Mexico
Research Site Active, not recruiting
Aguascalientes, Mexico
Research Site Active, not recruiting
Cuautla, Mexico
Research Site Active, not recruiting
Durango, Mexico
Research Site Withdrawn
Durango, Mexico
Research Site Active, not recruiting
Guadalajara, Mexico
Research Site Withdrawn
Guadalajara, Mexico
Research Site Withdrawn
Meridas, Mexico
Research Site Active, not recruiting
Mexico, Mexico
Research Site Withdrawn
Mexico, Mexico
Research Site Withdrawn
Monclova, Mexico
Research Site Active, not recruiting
Monterrey, Mexico
Research Site Withdrawn
Monterrey, Mexico
Research Site Withdrawn
Pachuca Hidalgo, Mexico
Research Site Active, not recruiting
Puebla, Mexico
Research Site Active, not recruiting
Queretaro, Mexico
Research Site Active, not recruiting
San Luis Potosí, Mexico
Netherlands
Research Site Active, not recruiting
Amersfoort, Netherlands
Research Site Active, not recruiting
Amsterdam, Netherlands
Research Site Active, not recruiting
Breda, Netherlands
Research Site Active, not recruiting
Eindhoven, Netherlands
Research Site Active, not recruiting
Groningen, Netherlands
Research Site Active, not recruiting
Hardenberg, Netherlands
Research Site Active, not recruiting
Hoogeveen, Netherlands
Research Site Active, not recruiting
Meppel, Netherlands
Research Site Active, not recruiting
Rotterdam, Netherlands
Research Site Active, not recruiting
Sneek, Netherlands
Research Site Active, not recruiting
Utrecht, Netherlands
Research Site Active, not recruiting
Velp, Netherlands
Research Site Active, not recruiting
Zoetermeer, Netherlands
New Zealand
Research Site Active, not recruiting
Christchurch, New Zealand
Research Site Active, not recruiting
Hamilton, New Zealand
Research Site Active, not recruiting
Nelson, New Zealand
Research Site Active, not recruiting
Newtown, New Zealand
Research Site Active, not recruiting
Palmerston North, New Zealand
Research Site Active, not recruiting
Takapuna, New Zealand
Research Site Active, not recruiting
Tauranga, New Zealand
Research Site Active, not recruiting
Wellington, New Zealand
Philippines
Research Site Active, not recruiting
Cebu, Philippines
Research Site Withdrawn
Davao City, Philippines
Research Site Active, not recruiting
Iloilo City, Philippines
Research Site Active, not recruiting
Manila, Philippines
Research Site Active, not recruiting
Marikina, Philippines
Research Site Active, not recruiting
Marikina City, Philippines
Research Site Active, not recruiting
Pasig, Philippines
Research Site Active, not recruiting
Quezon, Philippines
Research Site Withdrawn
Quezon, Philippines
Research Site Active, not recruiting
Quezon City, Philippines
Research Site Active, not recruiting
San Juan, Philippines
Poland
Research Site Active, not recruiting
Elbląg, Poland
Research Site Active, not recruiting
Gdynia, Poland
Research Site Active, not recruiting
Grodzisk Mazowiecki, Poland
Research Site Active, not recruiting
Grudziadz, Poland
Research Site Active, not recruiting
Katowice, Poland
Research Site Active, not recruiting
Lublin, Poland
Research Site Active, not recruiting
Ostrołęka, Poland
Research Site Active, not recruiting
Poznań, Poland
Research Site Active, not recruiting
Płock, Poland
Research Site Active, not recruiting
Słupsk, Poland
Research Site Active, not recruiting
Warszawa, Poland
Research Site Active, not recruiting
Wroclaw, Poland
Research Site Active, not recruiting
Wrocław, Poland
Research Site Active, not recruiting
Łask, Poland
Research Site Active, not recruiting
Łódź, Poland
Research Site Active, not recruiting
Łęczna, Poland
Romania
Research Site Active, not recruiting
Bacau, Romania
Research Site Active, not recruiting
Bucharest, Romania
Research Site Active, not recruiting
Bucuresti, Romania
Research Site Active, not recruiting
Buzau, Romania
Research Site Active, not recruiting
Cluj Napoca, Romania
Research Site Active, not recruiting
Craiova, Romania
Research Site Active, not recruiting
Iasi, Romania
Research Site Active, not recruiting
Oradea, Romania
Research Site Active, not recruiting
Ploiesti, Romania
Research Site Active, not recruiting
Satu-Mare, Romania
Research Site Active, not recruiting
Timisoara, Romania
Research Site Active, not recruiting
Timișoara, Romania
Research Site Active, not recruiting
Zalau, Romania
Russian Federation
Research Site Active, not recruiting
Ekaterinburg, Russian Federation
Research Site Active, not recruiting
Kemerovo, Russian Federation
Research Site Active, not recruiting
Krasnoyarsk, Russian Federation
Research Site Active, not recruiting
Moscow, Russian Federation
Research Site Active, not recruiting
Nizhnii Novgorod, Russian Federation
Research Site Active, not recruiting
Novosibirsk, Russian Federation
Research Site Withdrawn
Novosibirsk, Russian Federation
Research Site Active, not recruiting
Saint Petersburg, Russian Federation
Research Site Active, not recruiting
St. Peterburg, Russian Federation
Research Site Active, not recruiting
St.Рetersburg, Russian Federation
Research Site Active, not recruiting
Thymen, Russian Federation
Research Site Active, not recruiting
Tomsk, Russian Federation
Research Site Active, not recruiting
Yaroslavl, Russian Federation
Slovakia
Research Site Active, not recruiting
Bardejov, Slovakia
Research Site Active, not recruiting
Bratislava, Slovakia
Research Site Active, not recruiting
Kosice, Slovakia
Research Site Active, not recruiting
Lucenec, Slovakia
Research Site Active, not recruiting
Presov, Slovakia
Research Site Active, not recruiting
Roznava, Slovakia
Research Site Active, not recruiting
Trebisov, Slovakia
Research Site Active, not recruiting
Zilina, Slovakia
South Africa
Research Site Active, not recruiting
Boksburg, South Africa
Research Site Active, not recruiting
Brits, South Africa
Research Site Withdrawn
Cape Town, South Africa
Research Site Active, not recruiting
Cape Town, South Africa
Research Site Active, not recruiting
Centurion, South Africa
Research Site Active, not recruiting
Durban, South Africa
Research Site Active, not recruiting
Johannesburg, South Africa
Research Site Active, not recruiting
Kempton Park, South Africa
Research Site Active, not recruiting
Lenasia, South Africa
Research Site Active, not recruiting
Lynnwood Ridge, South Africa
Research Site Active, not recruiting
Paarl, South Africa
Research Site Active, not recruiting
Parktown, South Africa
Research Site Active, not recruiting
Phoenix, South Africa
Research Site Active, not recruiting
Port Elizabeth, South Africa
Research Site Active, not recruiting
Potchefstroom, South Africa
Research Site Withdrawn
Pretoria, South Africa
Research Site Active, not recruiting
Pretoria, South Africa
Research Site Active, not recruiting
Somerset West, South Africa
Research Site Active, not recruiting
Soweto, South Africa
Research Site Active, not recruiting
Umkomaas, South Africa
Spain
Research Site Active, not recruiting
A Coruña, Spain
Research Site Active, not recruiting
Alcalá de Henares, Spain
Research Site Active, not recruiting
Avila, Spain
Research Site Withdrawn
Centelles (Barcelona), Spain
Research Site Active, not recruiting
Ferrol, Spain
Research Site Active, not recruiting
Girona, Spain
Research Site Active, not recruiting
Granada, Spain
Research Site Active, not recruiting
Lleida, Spain
Research Site Active, not recruiting
Madrid, Spain
Research Site Withdrawn
Majadahonda, Spain
Research Site Active, not recruiting
Manacor, Spain
Research Site Active, not recruiting
Málaga, Spain
Research Site Withdrawn
Oviedo, Spain
Research Site Active, not recruiting
Palma de Mallorca, Spain
Research Site Active, not recruiting
Palma deMallorca, Spain
Research Site Withdrawn
Sabadell (Barcelona), Spain
Research Site Active, not recruiting
Salamanca, Spain
Research Site Active, not recruiting
Sevilla, Spain
Research Site Active, not recruiting
Tarragona, Spain
Research Site Withdrawn
Valencia, Spain
Taiwan
Research Site Active, not recruiting
Changhua, Taiwan
Research Site Active, not recruiting
Kaohsiung, Taiwan
Research Site Active, not recruiting
Kaohsiung Hsien, Taiwan
Research Site Active, not recruiting
Kweishan Shiang, Taiwan
Research Site Active, not recruiting
New Taipei City, Taiwan
Research Site Active, not recruiting
Taichung, Taiwan
Research Site Active, not recruiting
Tainan County, Taiwan
Research Site Active, not recruiting
Taipei, Taiwan
Thailand
Research Site Active, not recruiting
Bangkok, Thailand
Research Site Withdrawn
Bangkok, Thailand
Ukraine
Research Site Active, not recruiting
Chernivtsi, Ukraine
Research Site Active, not recruiting
Dnepropetrovsk, Ukraine
Research Site Active, not recruiting
Dnipropetrovsk, Ukraine
Research Site Active, not recruiting
Donetck, Ukraine
Research Site Active, not recruiting
Donetsk, Ukraine
Research Site Active, not recruiting
Ivano-Frankivsk, Ukraine
Research Site Active, not recruiting
Kharkiv, Ukraine
Research Site Active, not recruiting
Kiev, Ukraine
Research Site Active, not recruiting
Kyiv, Ukraine
Research Site Withdrawn
Kyiv, Ukraine
Research Site Active, not recruiting
Odesa, Ukraine
Research Site Active, not recruiting
Odessa, Ukraine
Research Site Active, not recruiting
Sumy, Ukraine
Research Site Active, not recruiting
Ternopil, Ukraine
Research Site Active, not recruiting
Uzhgorod, Ukraine
Research Site Active, not recruiting
Vinnytsia, Ukraine
Research Site Active, not recruiting
Zaporizhia, Ukraine
Research Site Active, not recruiting
Zaporizhzhya, Ukraine
Research Site Active, not recruiting
Zhytomyr, Ukraine
United Kingdom
Research Site Active, not recruiting
Aberdeen, United Kingdom
Research Site Active, not recruiting
Addlestone, United Kingdom
Research Site Active, not recruiting
Birmingham, United Kingdom
Research Site Active, not recruiting
Blackpool, United Kingdom
Research Site Active, not recruiting
Bradford, United Kingdom
Research Site Active, not recruiting
Bristol, United Kingdom
Research Site Active, not recruiting
Cambridge, United Kingdom
Research Site Active, not recruiting
Chippenham, United Kingdom
Research Site Active, not recruiting
Coventry, United Kingdom
Research Site Active, not recruiting
Dundee, United Kingdom
Research Site Active, not recruiting
Edinburgh, United Kingdom
Research Site Active, not recruiting
Glasgow, United Kingdom
Research Site Active, not recruiting
Hull, United Kingdom
Research Site Active, not recruiting
Inverness, United Kingdom
Research Site Active, not recruiting
Irvine, United Kingdom
Research Site Active, not recruiting
Leicester, United Kingdom
Research Site Active, not recruiting
Liverpool, United Kingdom
Research Site Active, not recruiting
Manchester, United Kingdom
Research Site Active, not recruiting
Northampton, United Kingdom
Research Site Active, not recruiting
Ormskirk, United Kingdom
Research Site Active, not recruiting
Peterborough, United Kingdom
Research Site Active, not recruiting
Plymouth, United Kingdom
Research Site Active, not recruiting
Redhill, United Kingdom
Research Site Active, not recruiting
Sheffield, United Kingdom
Research Site Active, not recruiting
Suffolk, United Kingdom
Research Site Active, not recruiting
Swansea, United Kingdom
Research Site Active, not recruiting
Trowbridge, United Kingdom
Research Site Active, not recruiting
West Sussex, United Kingdom
Sponsors and Collaborators
AstraZeneca
Investigators
Study Director: Nardev Khurmi, MD AstraZeneca
  More Information

No publications provided by AstraZeneca

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: AstraZeneca
ClinicalTrials.gov Identifier: NCT01144338     History of Changes
Other Study ID Numbers: D5551C00003, MB001-002, BCB109
Study First Received: June 10, 2010
Last Updated: August 12, 2015
Health Authority: United States: Food and Drug Administration

Keywords provided by AstraZeneca:
exenatide once weekly
cardiovascular
Bydureon
Amylin

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Endocrine System Diseases
Glucose Metabolism Disorders
Metabolic Diseases
Exenatide
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Hypoglycemic Agents
Incretins
Pharmacologic Actions
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on September 01, 2015