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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT01144338




Registration number
NCT01144338
Ethics application status
Date submitted
10/06/2010
Date registered
15/06/2010
Date last updated
8/08/2018

Titles & IDs
Public title
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
Scientific 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.
Secondary ID [1] 0 0
MB001-002
Secondary ID [2] 0 0
D5551C00003
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Type 2 Diabetes Mellitus 0 0
Condition category
Condition code
Metabolic and Endocrine 0 0 0 0
Diabetes

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Exenatide Once Weekly
Treatment: Drugs - Placebo

Experimental: Exenatide Once Weekly -

Placebo comparator: Placebo -


Treatment: Drugs: Exenatide Once Weekly
Subcutaneous injection, 2 mg, administered once weekly.

Treatment: Drugs: Placebo
Subcutaneous injection, matching volume of placebo, administered once weekly.
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Primary Efficacy Outcome MACE Events
Timepoint [1] 0 0
Time to first event. Information collected during study period (anticipated to be up to 7.5 years).
Primary outcome [2] 0 0
Primary Safety Outcome MACE Events
Timepoint [2] 0 0
Time to first event. Information collected during study period (anticipated to be up to 7.5 years).
Secondary outcome [1] 0 0
Secondary Efficacy Outcome All-Cause Mortality
Timepoint [1] 0 0
Time to first event. Information collected during study period (anticipated to be up to 7.5 years).
Secondary outcome [2] 0 0
Secondary Efficacy Outcome CV Death
Timepoint [2] 0 0
Time to first event. Information collected during study period (anticipated to be up to 7.5 years).
Secondary outcome [3] 0 0
Secondary Efficacy Outcome MI
Timepoint [3] 0 0
Time to first event. Information collected during study period (anticipated to be up to 7.5 years).
Secondary outcome [4] 0 0
Secondary Efficacy Outcome Stroke
Timepoint [4] 0 0
Time to first event. Information collected during study period (anticipated to be up to 7.5 years).
Secondary outcome [5] 0 0
Secondary Efficacy Outcome Hospitalization for ACS
Timepoint [5] 0 0
Time to first event. Information collected during study period (anticipated to be up to 7.5 years).
Secondary outcome [6] 0 0
Secondary Efficacy Outcome Hospitalization for HF
Timepoint [6] 0 0
Time to first event. Information collected during study period (anticipated to be up to 7.5 years).

Eligibility
Key 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.
Minimum age
18 Years
Maximum age
130 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s

The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
18/06/2010
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
24/04/2017
Sample size
Target
Accrual to date
Final
14752
Recruitment in Australia
Recruitment state(s)
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Research Site - Adelaide
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Research Site - Camperdown
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Research Site - Clayton
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Research Site - Sydney
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5000 - Adelaide
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2050 - Camperdown
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3168 - Clayton
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2250 - East Gosford
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5112 - Elizabeth Vale
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3065 - Fitzroy
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2605 - Garran
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3220 - Geelong
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3081 - Heidelberg West
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4131 - Meadobank
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4064 - Milton
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3050 - Parkville
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2006 - Sydney
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Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
AstraZeneca
Address
Country

Ethics approval
Ethics application status

Summary
Brief 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.
Trial website
https://clinicaltrials.gov/study/NCT01144338
Trial related presentations / publications
Davis TME, Giczewska A, Lokhnygina Y, Mentz RJ, Sattar N, Holman RR; EXSCEL Study Group. Effect of race on cardiometabolic responses to once-weekly exenatide: insights from the Exenatide Study of Cardiovascular Event Lowering (EXSCEL). Cardiovasc Diabetol. 2022 Jun 27;21(1):116. doi: 10.1186/s12933-022-01555-z.
Becker F, Dakin HA, Reed SD, Li Y, Leal J, Gustavson SM, Wittbrodt E, Hernandez AF, Gray AM, Holman RR. Lifetime cost-effectiveness simulation of once-weekly exenatide in type 2 diabetes: A cost-utility analysis based on the EXSCEL trial. Diabetes Res Clin Pract. 2022 Jan;183:109152. doi: 10.1016/j.diabres.2021.109152. Epub 2021 Nov 20.
Bethel MA, Stevens SR, Buse JB, Choi J, Gustavson SM, Iqbal N, Lokhnygina Y, Mentz RJ, Patel RA, Ohman P, Schernthaner G, Lecube A, Hernandez AF, Holman RR. Exploring the Possible Impact of Unbalanced Open-Label Drop-In of Glucose-Lowering Medications on EXSCEL Outcomes. Circulation. 2020 Apr 28;141(17):1360-1370. doi: 10.1161/CIRCULATIONAHA.119.043353. Epub 2020 Feb 26.
Standl E, Stevens SR, Lokhnygina Y, Bethel MA, Buse JB, Gustavson SM, Maggioni AP, Mentz RJ, Hernandez AF, Holman RR; EXSCEL Study Group. Confirming the Bidirectional Nature of the Association Between Severe Hypoglycemic and Cardiovascular Events in Type 2 Diabetes: Insights From EXSCEL. Diabetes Care. 2020 Mar;43(3):643-652. doi: 10.2337/dc19-1079. Epub 2019 Dec 27.
Reed SD, Li Y, Dakin HA, Becker F, Leal J, Gustavson SM, Kartman B, Wittbrodt E, Mentz RJ, Pagidipati NJ, Bethel MA, Gray AM, Holman RR, Hernandez AF; EXSCEL Study Group. Within-Trial Evaluation of Medical Resources, Costs, and Quality of Life Among Patients With Type 2 Diabetes Participating in the Exenatide Study of Cardiovascular Event Lowering (EXSCEL). Diabetes Care. 2020 Feb;43(2):374-381. doi: 10.2337/dc19-0950. Epub 2019 Dec 5.
Badjatiya A, Merrill P, Buse JB, Goodman SG, Katona B, Iqbal N, Pagidipati NJ, Sattar N, Holman RR, Hernandez AF, Mentz RJ, Patel MR, Jones WS. Clinical Outcomes in Patients With Type 2 Diabetes Mellitus and Peripheral Artery Disease: Results From the EXSCEL Trial. Circ Cardiovasc Interv. 2019 Dec;12(12):e008018. doi: 10.1161/CIRCINTERVENTIONS.119.008018. Epub 2019 Nov 22.
Clegg LE, Penland RC, Bachina S, Boulton DW, Thuresson M, Heerspink HJL, Gustavson S, Sjostrom CD, Ruggles JA, Hernandez AF, Buse JB, Mentz RJ, Holman RR. Effects of exenatide and open-label SGLT2 inhibitor treatment, given in parallel or sequentially, on mortality and cardiovascular and renal outcomes in type 2 diabetes: insights from the EXSCEL trial. Cardiovasc Diabetol. 2019 Oct 22;18(1):138. doi: 10.1186/s12933-019-0942-x.
Fudim M, White J, Pagidipati NJ, Lokhnygina Y, Wainstein J, Murin J, Iqbal N, Ohman P, Lopes RD, Reicher B, Holman RR, Hernandez AF, Mentz RJ. Effect of Once-Weekly Exenatide in Patients With Type 2 Diabetes Mellitus With and Without Heart Failure and Heart Failure-Related Outcomes: Insights From the EXSCEL Trial. Circulation. 2019 Nov 12;140(20):1613-1622. doi: 10.1161/CIRCULATIONAHA.119.041659. Epub 2019 Sep 23.
Bethel MA, Patel RA, Thompson VP, Merrill P, Reed SD, Li Y, Ahmadi S, Katona BG, Gustavson SM, Ohman P, Iqbal N, Gagel RF, Hernandez AF, Buse JB, Holman RR; EXSCEL Study Group. Changes in Serum Calcitonin Concentrations, Incidence of Medullary Thyroid Carcinoma, and Impact of Routine Calcitonin Concentration Monitoring in the EXenatide Study of Cardiovascular Event Lowering (EXSCEL). Diabetes Care. 2019 Jun;42(6):1075-1080. doi: 10.2337/dc18-2028. Epub 2019 Apr 22.
Mentz RJ, Bethel MA, Merrill P, Lokhnygina Y, Buse JB, Chan JC, Felicio JS, Goodman SG, Choi J, Gustavson SM, Iqbal N, Lopes RD, Maggioni AP, Ohman P, Pagidipati NJ, Poulter NR, Ramachandran A, Reicher B, Holman RR, Hernandez AF; EXSCEL Study Group. Effect of Once-Weekly Exenatide on Clinical Outcomes According to Baseline Risk in Patients With Type 2 Diabetes Mellitus: Insights From the EXSCEL Trial. J Am Heart Assoc. 2018 Oct 2;7(19):e009304. doi: 10.1161/JAHA.118.009304.
Wittbrodt ET, Eudicone JM, Bell KF, Enhoffer DM, Latham K, Green JB. Generalizability of glucagon-like peptide-1 receptor agonist cardiovascular outcome trials enrollment criteria to the US type 2 diabetes population. Am J Manag Care. 2018 Apr;24(8 Suppl):S146-S155.
Holman RR, Bethel MA, Mentz RJ, Thompson VP, Lokhnygina Y, Buse JB, Chan JC, Choi J, Gustavson SM, Iqbal N, Maggioni AP, Marso SP, Ohman P, Pagidipati NJ, Poulter N, Ramachandran A, Zinman B, Hernandez AF; EXSCEL Study Group. Effects of Once-Weekly Exenatide on Cardiovascular Outcomes in Type 2 Diabetes. N Engl J Med. 2017 Sep 28;377(13):1228-1239. doi: 10.1056/NEJMoa1612917. Epub 2017 Sep 14.
Mentz RJ, Bethel MA, Gustavson S, Thompson VP, Pagidipati NJ, Buse JB, Chan JC, Iqbal N, Maggioni AP, Marso SP, Ohman P, Poulter N, Ramachandran A, Zinman B, Hernandez AF, Holman RR. Baseline characteristics of patients enrolled in the Exenatide Study of Cardiovascular Event Lowering (EXSCEL). Am Heart J. 2017 May;187:1-9. doi: 10.1016/j.ahj.2017.02.005. Epub 2017 Feb 12.
Holman RR, Bethel MA, George J, Sourij H, Doran Z, Keenan J, Khurmi NS, Mentz RJ, Oulhaj A, Buse JB, Chan JC, Iqbal N, Kundu S, Maggioni AP, Marso SP, Ohman P, Pencina MJ, Poulter N, Porter LE, Ramachandran A, Zinman B, Hernandez AF. Rationale and design of the EXenatide Study of Cardiovascular Event Lowering (EXSCEL) trial. Am Heart J. 2016 Apr;174:103-10. doi: 10.1016/j.ahj.2015.12.009. Epub 2015 Dec 21.
Gaebler JA, Soto-Campos G, Alperin P, Cohen M, Blickensderfer A, Wintle M, Maggs D, Hoogwerf B, Han J, Pencek R, Peskin B. Health and economic outcomes for exenatide once weekly, insulin, and pioglitazone therapies in the treatment of type 2 diabetes: a simulation analysis. Vasc Health Risk Manag. 2012;8:255-64. doi: 10.2147/VHRM.S28744. Epub 2012 Apr 23.
Public notes

Contacts
Principal investigator
Name 0 0
Stephanie Gustavson, PhD
Address 0 0
AstraZeneca
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT01144338