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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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
AstraZeneca
ClinicalTrials.gov Identifier:
NCT01144338
First received: June 10, 2010
Last updated: May 31, 2017
Last verified: May 2017
  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
Intervention Model: Parallel Assignment
Masking: Triple (Participant, 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). ]
  • 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 Outcome Measures:
  • 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). ]

Enrollment: 14780
Actual Study Start Date: June 18, 2010
Study Completion Date: April 24, 2017
Primary Completion Date: April 21, 2017 (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 to 130 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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

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Kaunas, Lithuania, LT-48426
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Kaunas, Lithuania, LT-49287
Research Site
Kaunas, Lithuania, LT-49427
Research Site
Kedainiai, Lithuania, LT-57445
Research Site
Klaipeda, Lithuania, LT-92288
Research Site
Klaipeda, Lithuania, LT-94198
Research Site
Panevezys, Lithuania, LT-37355
Research Site
Ukmerge, Lithuania, LT-20184
Research Site
Utena, Lithuania, LT-28151
Research Site
Vilnius, Lithuania, 04318
Research Site
Vilnius, Lithuania, 08661
Research Site
Vilnius, Lithuania, 09112
Malaysia
Research Site
Alor Setar, Malaysia, 5460
Research Site
Batu Caves, Malaysia, 68100
Research Site
Kota Samarahan, Malaysia, 94300
Research Site
Kuala Lumpur, Malaysia, 59100
Research Site
Kuching, Malaysia, 93586
Research Site
Sungai Buloh, Malaysia, 47000
Research Site
Taiping, Malaysia, 34000
Mexico
Research Site
Aguascalientes, Mexico, 20127
Research Site
Cuautla, Mexico, 62746
Research Site
Durango, Mexico, 34080
Research Site
Guadalajara, Mexico, 44670
Research Site
Mexico, Mexico, 06700
Research Site
Mexico, Mexico, 10700
Research Site
Mexico, Mexico, 52763
Research Site
Mexico, Mexico, 6090
Research Site
Monterrey, Mexico, 64710
Research Site
Puebla, Mexico, 72190
Research Site
Queretaro, Mexico, 76000
Research Site
San Luis Potosí, Mexico, 78240
Netherlands
Research Site
Amersfoort, Netherlands, 3813 TZ
Research Site
Amsterdam, Netherlands, 1081 HV
Research Site
Eindhoven, Netherlands, 5611 NV
Research Site
Groningen, Netherlands, 9711 SG
Research Site
Hardenberg, Netherlands, 7772 SE
Research Site
Hoogeveen, Netherlands, 7909 AA
Research Site
Meppel, Netherlands, 7943 KA
Research Site
Rotterdam, Netherlands, 3021 HC
Research Site
Sneek, Netherlands, 8601 ZK
Research Site
Utrecht, Netherlands, 3584 CX
New Zealand
Research Site
Christchurch, New Zealand, 08011
Research Site
Christchurch, New Zealand, 8024
Research Site
Christchurch, New Zealand, 8041
Research Site
Hamilton, New Zealand, 3240
Research Site
Nelson, New Zealand, 7010
Research Site
Newtown, New Zealand, 6242
Research Site
Palmerston North, New Zealand, 4410
Research Site
Takapuna, New Zealand, 0622
Research Site
Tauranga, New Zealand, 3110
Research Site
Tauranga, New Zealand, 3112
Research Site
Wellington, New Zealand, 6021
Philippines
Research Site
Cebu, Philippines, 6000
Research Site
Iloilo City, Philippines, 5000
Research Site
Manila, Philippines, 1000
Research Site
Marikina City, Philippines, 1810
Research Site
Marikina, Philippines, 1810
Research Site
Pasig, Philippines, 1605
Research Site
Quezon City, Philippines, 1101
Research Site
Quezon, Philippines, 1000
Research Site
Quezon, Philippines, 1110
Research Site
Quezon, Philippines, 1113
Research Site
San Juan, Philippines
Poland
Research Site
Elbląg, Poland, 82-300
Research Site
Gdynia, Poland, 81-472
Research Site
Grodzisk Mazowiecki, Poland, 05-825
Research Site
Grudziadz, Poland, 86-300
Research Site
Katowice, Poland, 40-752
Research Site
Lublin, Poland, 20-090
Research Site
Ostrołęka, Poland, 07-400
Research Site
Poznań, Poland, 60-659
Research Site
Płock, Poland, 09-402
Research Site
Słupsk, Poland, 76-200
Research Site
Warszawa, Poland, 04-635
Research Site
Wroclaw, Poland, 50-127
Research Site
Wrocław, Poland, 50-403
Research Site
Wrocław, Poland, 51-124
Research Site
Łódź, Poland, 94-074
Research Site
Łęczna, Poland, 21-010
Romania
Research Site
Bacau, Romania, 600164
Research Site
Bucharest, Romania, 010507
Research Site
Bucuresti, Romania, 010627
Research Site
Bucuresti, Romania, 020725
Research Site
Bucuresti, Romania, 030306
Research Site
Bucuresti, Romania, 042122
Research Site
Buzau, Romania, 120203
Research Site
Cluj Napoca, Romania, 400006
Research Site
Cluj Napoca, Romania, 400349
Research Site
Craiova, Romania, 200147
Research Site
Iasi, Romania, 700111
Research Site
Oradea, Romania, 410169
Research Site
Ploiesti, Romania, 100477
Research Site
Satu-Mare, Romania, 440055
Research Site
Timisoara, Romania, 300125
Research Site
Timișoara, Romania, 300456
Research Site
Zalau, Romania, 450129
Russian Federation
Research Site
Ekaterinburg, Russian Federation, 620219
Research Site
Kemerovo, Russian Federation, 650002
Research Site
Krasnoyarsk, Russian Federation, 660022
Research Site
Moscow, Russian Federation, 105120
Research Site
Moscow, Russian Federation, 129110
Research Site
Nizhnii Novgorod, Russian Federation, 603018
Research Site
Novosibirsk, Russian Federation, 630087
Research Site
Saint Petersburg, Russian Federation, 196601
Research Site
St. Peterburg, Russian Federation, 195112
Research Site
St.Рetersburg, Russian Federation, 198035
Research Site
Thymen, Russian Federation, 625023
Research Site
Tomsk, Russian Federation, 634012
Research Site
Tomsk, Russian Federation, 634050
Research Site
Yaroslavl, Russian Federation, 150010
Research Site
Yaroslavl, Russian Federation, 150062
Slovakia
Research Site
Bardejov, Slovakia, 085 01
Research Site
Bratislava, Slovakia, 813 69
Research Site
Bratislava, Slovakia, 82606
Research Site
Kosice, Slovakia, 040 01
Research Site
Kosice, Slovakia, 04022
Research Site
Kosice, Slovakia, 044 24
Research Site
Lucenec, Slovakia, 984 01
Research Site
Presov, Slovakia, 080 01
Research Site
Roznava, Slovakia, 048 01
Research Site
Trebisov, Slovakia, 075 01
Research Site
Zilina, Slovakia, 010 01
South Africa
Research Site
Boksburg, South Africa, 1459
Research Site
Brits, South Africa, 0250
Research Site
Cape Town, South Africa, 7460
Research Site
Cape Town, South Africa, 7500
Research Site
Cape Town, South Africa, 7700
Research Site
Centurion, South Africa, 0157
Research Site
Durban, South Africa, 4001
Research Site
Durban, South Africa, 4052
Research Site
Johannesburg, South Africa, 2198
Research Site
Kempton Park, South Africa, 1619
Research Site
Lenasia, South Africa, 1827
Research Site
Paarl, South Africa, 7646
Research Site
Parktown, South Africa, 2193
Research Site
Phoenix, South Africa, 4068
Research Site
Port Elizabeth, South Africa, 6014
Research Site
Potchefstroom, South Africa, 2531
Research Site
Pretoria, South Africa, 0001
Research Site
Pretoria, South Africa, 0014
Research Site
Pretoria, South Africa, 0101
Research Site
Somerset West, South Africa, 7130
Research Site
Soweto, South Africa, 2013
Research Site
Umkomaas, South Africa, 4170
Spain
Research Site
A Coruña, Spain, 15006
Research Site
Alcalá de Henares, Spain, 28805
Research Site
Avila, Spain, 05004
Research Site
Ferrol, Spain, 15405
Research Site
Girona, Spain, 17007
Research Site
Granada, Spain, 18004
Research Site
Granada, Spain, 18012
Research Site
Lleida, Spain, 25198
Research Site
Madrid, Spain, 28007
Research Site
Madrid, Spain, 28034
Research Site
Madrid, Spain, 28046
Research Site
Madrid, Spain, 28702
Research Site
Manacor, Spain, 07500
Research Site
Málaga, Spain, 29006
Research Site
Palma de Mallorca, Spain, 07198
Research Site
Palma deMallorca, Spain, 07010
Research Site
Salamanca, Spain, 37003
Research Site
Sevilla, Spain, 41010
Research Site
Tarragona, Spain, 43007
Taiwan
Research Site
Changhua, Taiwan, 500
Research Site
Kaohsiung Hsien, Taiwan, 83301
Research Site
Kaohsiung, Taiwan, 80756
Research Site
Kweishan Shiang, Taiwan, 333
Research Site
New Taipei City, Taiwan, 23148
Research Site
Taichung, Taiwan, 40705
Research Site
Taichung, Taiwan, 433
Research Site
Tainan County, Taiwan
Research Site
Taipei, Taiwan, 100
Research Site
Taipei, Taiwan, 11490
Thailand
Research Site
Bangkok, Thailand, 10400
Ukraine
Research Site
Chernivtsi, Ukraine, 58022
Research Site
Dnepropetrovsk, Ukraine, 49006
Research Site
Dnipropetrovsk, Ukraine, 49027
Research Site
Donetck, Ukraine, 83045
Research Site
Donetsk, Ukraine, 83059
Research Site
Donetsk, Ukraine, 83114
Research Site
Ivano-Frankivsk, Ukraine, 76000
Research Site
Kharkiv, Ukraine, 61029
Research Site
Kharkiv, Ukraine, 61037
Research Site
Kharkiv, Ukraine, 61039
Research Site
Kharkiv, Ukraine, 61178
Research Site
Kiev, Ukraine, 04114
Research Site
Kiev, Ukraine, 07050
Research Site
Kyiv, Ukraine, 2091
Research Site
Kyiv, Ukraine, 3680
Research Site
Odesa, Ukraine, 65025
Research Site
Odesa, Ukraine, 65114
Research Site
Sumy, Ukraine, 40022
Research Site
Ternopil, Ukraine, 46002
Research Site
Uzhgorod, Ukraine, 88014
Research Site
Vinnytsia, Ukraine, 21010
Research Site
Zaporizhia, Ukraine, 69001
Research Site
Zaporizhzhya, Ukraine, 69118
Research Site
Zhytomyr, Ukraine, 10002
United Kingdom
Research Site
Aberdeen, United Kingdom, AB25 2ZD
Research Site
Addlestone, United Kingdom, KT15 2BH
Research Site
Birmingham, United Kingdom, B9 5SS
Research Site
Blackpool, United Kingdom, FY4 3AD
Research Site
Bradford, United Kingdom, BD9 6RJ
Research Site
Bristol, United Kingdom, BS10 5NB
Research Site
Cambridge, United Kingdom, CB2 0QQ
Research Site
Chippenham, United Kingdom, SN14 6GT
Research Site
Coventry, United Kingdom, CV2 2DX
Research Site
Dundee, United Kingdom, DD1 9SY
Research Site
Edinburgh, United Kingdom, EH4 2XU
Research Site
Glasgow, United Kingdom, G12 8TA
Research Site
Hull, United Kingdom, HU3 2JZ
Research Site
Inverness, United Kingdom, IV2 3JH
Research Site
Irvine, United Kingdom, KA12 0AY
Research Site
Leicester, United Kingdom, LE5 4PW
Research Site
Liverpool, United Kingdom, L7 8XP
Research Site
Manchester, United Kingdom, M8 5RB
Research Site
Northampton, United Kingdom, NN1 5BD
Research Site
Ormskirk, United Kingdom, L39 2AZ
Research Site
Peterborough, United Kingdom, PE8 6PL
Research Site
Plymouth, United Kingdom, PL5 3JB
Research Site
Plymouth, United Kingdom, PL6 8BX
Research Site
Redhill, United Kingdom, RH1 5RH
Research Site
Sheffield, United Kingdom, S5 7AU
Research Site
Suffolk, United Kingdom, IP33 2QZ
Research Site
Swansea, United Kingdom, SN6 6NL
Research Site
Trowbridge, United Kingdom, BA14 8QA
Research Site
West Sussex, United Kingdom, RH10 7DX
Sponsors and Collaborators
AstraZeneca
Investigators
Study Director: Stephanie Gustavson, PhD AstraZeneca
Study Director: Group Director Global Clinical Research Bristol-Myers Squibb
  More Information

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 ( Other Identifier: Bristol Myers Squibb )
BCB109 ( Other Identifier: Bristol-Myers Squibb )
Study First Received: June 10, 2010
Last Updated: May 31, 2017

Keywords provided by AstraZeneca:
exenatide once weekly
cardiovascular
Bydureon
Amylin

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

ClinicalTrials.gov processed this record on August 17, 2017