Exenatide Versus Glimepiride in Patients With Type 2 Diabetes
NCT ID: NCT00359762
Last Updated: 2015-09-15
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
1029 participants
INTERVENTIONAL
2006-09-30
2011-03-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Exenatide
exenatide
subcutaneous injection (5mcg or 10mcg), twice a day
Glimepiride
glimepiride
oral tablet (titrated to maximally tolerated dose), once daily
Interventions
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exenatide
subcutaneous injection (5mcg or 10mcg), twice a day
glimepiride
oral tablet (titrated to maximally tolerated dose), once daily
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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.
Exclusion Criteria
* 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
18 Years
85 Years
ALL
No
Sponsors
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Eli Lilly and Company
INDUSTRY
AstraZeneca
INDUSTRY
Responsible Party
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Principal Investigators
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James Malone, MD
Role: STUDY_DIRECTOR
Eli Lilly and Company
Locations
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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
Countries
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References
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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.
Schernthaner 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.
Gallwitz 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.
Other Identifiers
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H8O-EW-GWBE
Identifier Type: -
Identifier Source: org_study_id
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