Exenatide Versus Glimepiride in Patients With Type 2 Diabetes
Long Term Treatment With Exenatide Versus Glimepiride in Patients With Type 2 Diabetes Pretreated With Metformin (EUREXA: European Exenatide Study)
1 other identifier
interventional
1,029
14 countries
114
Brief Summary
This study assesses the effects of twice-daily subcutaneous injection exenatide versus treatment with sulfonylurea (glimepiride) on long-term glycemic control and beta-cell function.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3 type-2-diabetes-mellitus
Started Sep 2006
Longer than P75 for phase_3 type-2-diabetes-mellitus
114 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 31, 2006
CompletedFirst Posted
Study publicly available on registry
August 2, 2006
CompletedStudy Start
First participant enrolled
September 1, 2006
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2011
CompletedResults Posted
Study results publicly available
March 14, 2013
CompletedSeptember 15, 2015
August 1, 2015
4.5 years
July 31, 2006
March 29, 2012
August 17, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Number of Patients With Treatment Failure
Treatment failure is defined as one of the following:1. HbA1c exceeding 9% at any visit after the initial 3 months of treatment (i.e., earliest at Month 6), on the maximally tolerated dose of antidiabetic agents. 2. HbA1c exceeding 7% at 2 consecutive visits 3 months apart, after the initial 6 months of treatment (i.e., earliest at Month 9), on the maximally tolerated dose of antidiabetic agents.
Baseline to end of Period II (up to 4.5 years)
Time to Treatment Failure
Treatment failure is defined as one of the following:1. HbA1c exceeding 9% at any visit after the initial 3 months of treatment (i.e., earliest at Month 6), on the maximally tolerated dose of antidiabetic agents. 2. HbA1c exceeding 7% at 2 consecutive visits 3 months apart, after the initial 6 months of treatment (i.e., earliest at Month 9), on the maximally tolerated dose of antidiabetic agents.
Baseline to end of Period II (up to 4.5 years)
Secondary Outcomes (25)
Homeostasis Model Assessment of Beta-cell Function (HOMA-B) at Year 3
Year 3 in Period II
Change in HOMA-B From Baseline to Endpoint
Baseline, end of Period II (up to 4.5 years)
Fasting Proinsulin/Insulin Ratio at Year 3
Year 3 in Period II
Change in Fasting Proinsulin/Insulin Ratio From Baseline to Endpoint.
Baseline, end of Period II (up to 4.5 years)
Ratio of the 30 Minute Increment in Plasma Insulin Concentration and the 30 Minute Increment in Plasma Glucose During the Oral Glucose Tolerance Test (DI30/DG30 Ratio) at Year 3
Year 3 in Period II
- +20 more secondary outcomes
Study Arms (2)
Exenatide
EXPERIMENTALGlimepiride
ACTIVE COMPARATORInterventions
oral tablet (titrated to maximally tolerated dose), once daily
Eligibility Criteria
You may qualify if:
- Diagnosed with type 2 diabetes mellitus.
- Treated with diet and exercise and a stable, maximally tolerated dose of metformin for at least 3 months prior to screening.
- HbA1c \>=6.5% and \<=9.0%.
- Body Mass Index (BMI) \>=25 kg/m\^2 and \<40 kg/m\^2.
You may not qualify if:
- Participated in an interventional medical, surgical, or pharmaceutical study within 30 days prior to screening.
- Characteristics contraindicating metformin or glimepiride use.
- Receiving drugs that directly affect gastrointestinal motility.
- Receiving chronic (lasting longer than 2 weeks) systemic glucocorticoid therapy.
- Have used any prescription drug to promote weight loss within 3 months prior to screening.
- Treated for longer than 2 weeks with any of the following medications within 3 months prior to screening: \*insulin; \*thiazolidinediones; \*alpha-glucosidase inhibitors; \*sulfonylurea; \*meglitinides
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- AstraZenecalead
- Eli Lilly and Companycollaborator
Study Sites (114)
Research Site
Graz, Austria
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Innsbruck, Austria
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Salzburg, Austria
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Vienna, Austria
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Beroun, Czechia
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České Budějovice, Czechia
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Hradec Králové, Czechia
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Liberec, Czechia
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Písek, Czechia
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Prague, Czechia
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Třebíč, Czechia
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Helsinki, Finland
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Kuopio, Finland
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Pori, Finland
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Vaasa, Finland
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Alençon, France
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Bois-Guillaume, France
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Bourg-des-Comptes, France
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Broglie, France
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Bron, France
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Fléville-devant-Nancy, France
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Le Creusot, France
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Le Mans, France
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Loudun, France
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Montigny-lès-Metz, France
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Nevers, France
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Strasbourg, France
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Thouars, France
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Tours, France
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Valréas, France
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Vénissieux, France
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Vihiers, France
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Altona, Germany
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Aschaffenburg, Germany
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Bad Staffelstein, Germany
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Dresden, Germany
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Eisenach, Germany
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Essen, Germany
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Essen Schonnebeck, Germany
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Falkensee, Germany
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Fulda, Germany
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Hamburg, Germany
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Hamburg-Ottmarschen, Germany
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Heidelberg, Germany
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Leipzig, Germany
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Münster, Germany
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Saarbrücken, Germany
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Saint Ingbert, Germany
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Schenklengsfeld, Germany
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Schkeuditz, Germany
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Witten, Germany
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Budapest, Hungary
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Gyula, Hungary
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Kecskemét, Hungary
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Veszprém, Hungary
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Zalaegerszeg, Hungary
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County Galway, Ireland
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County Waterford, Ireland
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Dublin, Ireland
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Haifa, Israel
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Holon, Israel
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Jerusalem, Israel
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Tel Litwinsky, Israel
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Ancona, Italy
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Arenzano, Italy
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Atri, Italy
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Bergamo, Italy
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Catanzaro, Italy
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Florence, Italy
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Foggia, Italy
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Forlì, Italy
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Genova, Italy
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Grosseto, Italy
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Milan, Italy
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Monserrato (Cagliari), Italy
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Napoli, Italy
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Palermo, Italy
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Perugia, Italy
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Pescara, Italy
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Pisa, Italy
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Ravenna, Italy
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Roma, Italy
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San Benedetto del Tronto, Italy
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Siena, Italy
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Treviso, Italy
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Verona, Italy
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Celaya, Guanajuato, Mexico
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Pachuca, Hidalgo, Mexico
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Mexico City, Mexico City, Mexico
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Monterrey, Nuevo León, Mexico
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Bialystok, Poland
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Bydgoszcz, Poland
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Lublin, Poland
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Szczecin, Poland
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Warsaw, Poland
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Wroclaw, Poland
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Barcelona, Spain
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Madrid, Spain
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Fribourg, Switzerland
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Geneva, Switzerland
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Lausanne, Switzerland
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Lucerne, Switzerland
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Bath, United Kingdom
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Belfast, United Kingdom
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Brandford on Avon, United Kingdom
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County Antrim, United Kingdom
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Downpatrick, United Kingdom
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Frome, United Kingdom
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Midsomer Norton, United Kingdom
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Omagh, United Kingdom
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Penzance, United Kingdom
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Plymouth, United Kingdom
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Southdown, United Kingdom
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Wiltshire, United Kingdom
Related Publications (3)
Simo R, Guerci B, Schernthaner G, Gallwitz B, Rosas-Guzman J, Dotta F, Festa A, Zhou M, Kiljanski J. Long-term changes in cardiovascular risk markers during administration of exenatide twice daily or glimepiride: results from the European exenatide study. Cardiovasc Diabetol. 2015 Sep 4;14:116. doi: 10.1186/s12933-015-0279-z.
PMID: 26338040DERIVEDSchernthaner G, Rosas-Guzman J, Dotta F, Guerci B, Simo R, Festa A, Kiljanski J, Zhou M, Gallwitz B. Treatment escalation options for patients with type 2 diabetes after failure of exenatide twice daily or glimepiride added to metformin: results from the prospective European Exenatide (EUREXA) study. Diabetes Obes Metab. 2015 Jul;17(7):689-98. doi: 10.1111/dom.12471. Epub 2015 May 8.
PMID: 25846577DERIVEDGallwitz B, Guzman J, Dotta F, Guerci B, Simo R, Basson BR, Festa A, Kiljanski J, Sapin H, Trautmann M, Schernthaner G. Exenatide twice daily versus glimepiride for prevention of glycaemic deterioration in patients with type 2 diabetes with metformin failure (EUREXA): an open-label, randomised controlled trial. Lancet. 2012 Jun 16;379(9833):2270-8. doi: 10.1016/S0140-6736(12)60479-6. Epub 2012 Jun 9.
PMID: 22683137DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Limitations and Caveats
Only patients who reached primary endpoint 12 months or more before the projected end of the study could enter period III.
Results Point of Contact
- Title
- Peter Ohman, Medical Science Director
- Organization
- AstraZeneca
Study Officials
- STUDY DIRECTOR
James Malone, MD
Eli Lilly and Company
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- GT60
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 31, 2006
First Posted
August 2, 2006
Study Start
September 1, 2006
Primary Completion
March 1, 2011
Study Completion
March 1, 2011
Last Updated
September 15, 2015
Results First Posted
March 14, 2013
Record last verified: 2015-08