Exenatide Versus Glimepiride in Patients With Type 2 Diabetes

NCT ID: NCT00359762

Last Updated: 2015-09-15

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

1029 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-09-30

Study Completion Date

2011-03-31

Brief Summary

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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.

Detailed Description

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Conditions

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Type 2 Diabetes Mellitus

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Exenatide

Group Type EXPERIMENTAL

exenatide

Intervention Type DRUG

subcutaneous injection (5mcg or 10mcg), twice a day

Glimepiride

Group Type ACTIVE_COMPARATOR

glimepiride

Intervention Type DRUG

oral tablet (titrated to maximally tolerated dose), once daily

Interventions

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exenatide

subcutaneous injection (5mcg or 10mcg), twice a day

Intervention Type DRUG

glimepiride

oral tablet (titrated to maximally tolerated dose), once daily

Intervention Type DRUG

Other Intervention Names

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Byetta Amaryl

Eligibility Criteria

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Inclusion Criteria

* 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.

Exclusion Criteria

* 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
Minimum Eligible Age

18 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Eli Lilly and Company

INDUSTRY

Sponsor Role collaborator

AstraZeneca

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

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

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Countries

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Austria Czechia Finland France Germany Hungary Ireland Israel Italy Mexico Poland Spain Switzerland United Kingdom

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.

Reference Type DERIVED
PMID: 26338040 (View on PubMed)

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.

Reference Type DERIVED
PMID: 25846577 (View on PubMed)

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.

Reference Type DERIVED
PMID: 22683137 (View on PubMed)

Other Identifiers

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H8O-EW-GWBE

Identifier Type: -

Identifier Source: org_study_id

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