Exenatide Versus Glimepiride in Patients With Type 2 Diabetes

Condition(s) targeted: Type 2 Diabetes Mellitus

Intervention: exenatide (Drug); glimepiride (Drug)

Phase: Phase 3

Status: Active, not recruiting

Sponsored by: Amylin Pharmaceuticals, Inc.

Official(s) and/or principal investigator(s):
James Malone, MD, Study Director, Affiliation: Eli Lilly and Company

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.

Official title: Long Term Treatment With Exenatide Versus Glimepiride in Patients With Type 2 Diabetes Pretreated With Metformin (EUREXA: European Exenatide Study)

Study design: Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study

Primary outcome: To test the hypothesis that exenatide injected twice daily is non-inferior to glimepiride given once-daily before breakfast to patients with type 2 diabetes.

Secondary outcome:

To compare the effects of exenatide and glimepiride on beta-cell function.

To compare the effects of exenatide and glimepiride on various pharmacodynamic measures.

To compare the safety and tolerability of exenatide and glimepiride.

To compare the effects of exenatide and glimepiride on the occurrence of hypoglycemic episodes.

To study the efficacy and safety of different treatment options.

To study the level of anti-exenatide antibodies in patients randomized to exenatide.

Minimum age: 18 Years. Maximum age: 85 Years. Gender(s): Both.

Criteria:

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

Research Site, Graz, Austria

Research Site, Wien, Austria

Research Site, Salzburg, Austria

Research Site, Innsbruck, Austria

Research Site, Pisek, Czech Republic

Research Site, Trebic, Czech Republic

Research Site, Liberec, Czech Republic

Research Site, Praha, Czech Republic

Research Site, Hradec Kralove, Czech Republic

Research Site, Zlin, Czech Republic

Research Site, Ceske Budejovice, Czech Republic

Research Site, Beroun, Czech Republic

Research Site, Kuopio, Finland

Research Site, Helsinki, Finland

Research Site, Pori, Finland

Research Site, Vaasa, Finland

Research Site, Dommartin-les Toul, France

Research Site, Lyon, France

Research Site, Saint-Etienne, France

Research Site, Nevers, France

Research Site, Bron, France

Research Site, Strasbourg, France

Research Site, Tours, France

Research Site, Angers, France

Research Site, Orleans, France

Research Site, Alencon, France

Research Site, Bois-Guillaume, France

Research Site, Fleville Devant Nancy, France

Research Site, Blois, France

Research Site, Vihiers, France

Research Site, Broglie, France

Research Site, Armentieres, France

Research Site, Loudun, France

Research Site, Thouars, France

Research Site, Valreas, France

Research Site, Mougins, France

Research Site, Saint Gervais la Foret, France

Research Site, Vénissieux, France

Research Site, Le Creusot, France

Research Site, Bourg des Comptes, France

Research Site, Montigny les Metz, France

Research Site, Le Mans, France

Research Site, Munster, Germany

Research Site, Essen Schonnebeck, Germany

Research Site, Essen, Germany

Research Site, Witten, Germany

Research Site, Berlin, Germany

Research Site, Hamburg-Altona, Germany

Research Site, Eckernforde, Germany

Research Site, Dresden, Germany

Research Site, Heidelberg, Germany

Research Site, Staffelstein, Germany

Research Site, Saarbrucken, Germany

Research Site, Aschaffenburg, Germany

Research Site, Schenklengsfeld, Germany

Research Site, Falkensee, Germany

Research Site, Hamburg, Germany

Research Site, Eisenach, Germany

Research Site, St. Ingbert, Germany

Research Site, Fulda, Germany

Research Site, Schkeuditz, Germany

Research Site, Leipzig, Germany

Research Site, Hamburg-Ottmarschen, Germany

Research Site, Gyula, Hungary

Research Site, Veszprem, Hungary

Research Site, Budapest, Hungary

Research Site, Kecskemet, Hungary

Research Site, Zalaegerszeg, Hungary

Research Site, County Waterford, Ireland

Research Site, Dublin, Ireland

Research Site, County Galway, Ireland

Research Site, Tel Hashomer, Israel

Research Site, Haifa, Israel

Research Site, Holon, Israel

Research Site, Jerusalem, Israel

Research Site, Siena, Italy

Research Site, Bari, Italy

Research Site, Forli, Italy

Research Site, Milano, Italy

Research Site, Palermo, Italy

Research Site, Verona, Italy

Research Site, Perugia, Italy

Research Site, Ancona, Italy

Research Site, Foggia, Italy

Research Site, Roma, Italy

Research Site, Pescara, Italy

Research Site, Ravenna, Italy

Research Site, Udine, Italy

Research Site, Bergamo, Italy

Research Site, Catanzaro, Italy

Research Site, Treviso, Italy

Research Site, Prato, Italy

Research Site, Napoli, Italy

Research Site, Messina, Italy

Research Site, Firenze, Italy

Research Site, Genova, Italy

Research Site, Varese, Italy

Research Site, San Benedetto del Tronto, Italy

Research Site, Arenzano, Italy

Research Site, Potenza, Italy

Research Site, Brescia, Italy

Research Site, Atri, Italy

Research Site, Grosseto, Italy

Research Site, Pisa, Italy

Research Site, Monserrato (Cagliari), Italy

Research Site, San Luis Potosi, Mexico

Research Site, Warszawa, Poland

Research Site, Lublin, Poland

Research Site, Bialystok, Poland

Research Site, Bydgoszcz, Poland

Research Site, Wroclaw, Poland

Research Site, Szczecin, Poland

Research Site, Madrid, Spain

Research Site, Sevilla, Spain

Research Site, Barcelona, Spain

Research Site, Palma de Mallorca, Spain

Research Site, Santa Cruz de Tenerife, Spain

Research Site, Fribourg, Switzerland

Research Site, Lausanne, Switzerland

Research Site, Geneve, Switzerland

Research Site, Bern, Switzerland

Research Site, Luzern, Switzerland

Research Site, Geneva, Switzerland

Research Site, Plymouth, United Kingdom

Research Site, Penzance, United Kingdom

Research Site, St. Austell, United Kingdom

Research Site, Fowey, United Kingdom

Research Site, Bath, United Kingdom

Research Site, Wiltshire, United Kingdom

Research Site, Midsomer Norton, United Kingdom

Research Site, Southdown, United Kingdom

Research Site, Frome, United Kingdom

Research Site, Whiteabbey, United Kingdom

Research Site, Downpatrick, United Kingdom

Research Site, Belfast, United Kingdom

Research Site, Omagh, United Kingdom

Research Site, Torreon, Coahuila, Mexico

Research Site, Mexico City, Distrito Federal, Mexico

Research Site, Celaya, Guanajuato, Mexico

Research Site, Pachuca, Hidalgo, Mexico

Research Site, Monterrey, Nuevo Leon, Mexico

Starting date: September 2006
Ending date: December 2009
Last updated: December 18, 2007