Clinical trial NCT00359762: Exenatide Versus Glimepiride in Patients With Type 2 Diabetes
Official title: Long Term Treatment With Exenatide Versus Glimepiride in Patients With Type 2 Diabetes Pretreated With Metformin (EUREXA: European Exenatide Study)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Type 2 Diabetes Mellitus
Keywords: exenatide
diabetes
Amylin
Lilly
glimepiride
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
Collaborators: name: Eli Lilly and Company
First posted: 2006-08-02
Enrollment: 1029
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility 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

Primary outcomes:
measure: Number of Patients With Treatment Failure
timeFrame: Baseline to end of Period II (up to 4.5 years)
measure: Time to Treatment Failure
timeFrame: Baseline to end of Period II (up to 4.5 years)
Secondary outcomes:
measure: Homeostasis Model Assessment of Beta-cell Function (HOMA-B) at Year 3
timeFrame: Year 3 in Period II
measure: Change in HOMA-B From Baseline to Endpoint
timeFrame: Baseline, end of Period II (up to 4.5 years)
measure: Fasting Proinsulin/Insulin Ratio at Year 3
timeFrame: Year 3 in Period II
measure: Change in Fasting Proinsulin/Insulin Ratio From Baseline to Endpoint.
timeFrame: Baseline, end of Period II (up to 4.5 years)
measure: 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
timeFrame: Year 3 in Period II
measure: Change in DI30/DG30 Ratio From Baseline to Endpoint
timeFrame: Baseline, end of Period II (up to 4.5 years)
measure: Disposition Index at Year 3
timeFrame: Year 3 in Period II
measure: Change in Disposition Index From Baseline to Endpoint
timeFrame: Baseline, end of Period II (up to 4.5 years)
measure: Change in HbA1c From Baseline to Year 3
timeFrame: Baseline, Year 3 in Period II
measure: Change in HbA1c From Baseline to Endpoint
timeFrame: Baseline, end of Period II (up to 4.5 years)
measure: Fasting Plasma Glucose at Year 3
timeFrame: Year 3 in Period II
measure: Change in Fasting Plasma Glucose From Baseline to Endpoint
timeFrame: Baseline, end of Period II (up to 4.5 years)
measure: Postprandial (2 Hours) Plasma Glucose at Year 3
timeFrame: Year 3 in Period II
measure: Change in Postprandial (2 Hours) Plasma Glucose From Baseline to Endpoint
timeFrame: Baseline, end of Period II (up to 4.5 years)
measure: Change in Body Weight From Baseline to Year 3
timeFrame: Baseline, Year 3 in Period II
measure: Systolic Blood Pressure at Year 3
timeFrame: Year 3 in Period II
measure: Diastolic Blood Pressure at Year 3
timeFrame: Year 3 in Period II
measure: Heart Rate at Year 3
timeFrame: Year 3 in Period II
measure: Triglycerides at Year 3
timeFrame: Year 3 in Period II
measure: Total Cholesterol at Year 3
timeFrame: Year 3 in Period II
measure: High-density Lipoprotein (HDL) Cholesterol at Year 3
timeFrame: Year 3 in Period II
measure: Hypoglycemia Rate Per Year
timeFrame: Baseline to end of Period II (up to 4.5 years)
measure: Change in HbA1c From Baseline to Year 2 for Patients Randomized at Entry in Period III
timeFrame: Baseline in Period III, Year 2 in Period III
measure: Change in HbA1c From Baseline to Year 2 for Patients Not Randomized at Entry in Period III
timeFrame: Baseline in Period III, Year 2 in Period III
measure: Hypoglycemia Rate Per Year in Period III
timeFrame: Start of Period III to end of study
Other outcomes:
Locations:
city: Graz
country: Austria
facility: Research Site
city: Innsbruck
country: Austria
facility: Research Site
city: Salzburg
country: Austria
facility: Research Site
city: Vienna
country: Austria
facility: Research Site
city: Beroun
country: Czech Republic
facility: Research Site
city: Ceske Budejovice
country: Czech Republic
facility: Research Site
city: Hradec Kralove
country: Czech Republic
facility: Research Site
city: Liberec
country: Czech Republic
facility: Research Site
city: Pisek
country: Czech Republic
facility: Research Site
city: Praha
country: Czech Republic
facility: Research Site
city: Trebic
country: Czech Republic
facility: Research Site
city: Helsinki
country: Finland
facility: Research Site
city: Kuopio
country: Finland
facility: Research Site
city: Pori
country: Finland
facility: Research Site
city: Vaasa
country: Finland
facility: Research Site
city: Alencon
country: France
facility: Research Site
city: Bois-Guillaume
country: France
facility: Research Site
city: Bourg des Comptes
country: France
facility: Research Site
city: Broglie
country: France
facility: Research Site
city: Bron
country: France
facility: Research Site
city: Fleville Devant Nancy
country: France
facility: Research Site
city: Le Creusot
country: France
facility: Research Site
city: Le Mans
country: France
facility: Research Site
city: Loudun
country: France
facility: Research Site
city: Montigny les Metz
country: France
facility: Research Site
city: Nevers
country: France
facility: Research Site
city: Strasbourg
country: France
facility: Research Site
city: Thouars
country: France
facility: Research Site
city: Tours
country: France
facility: Research Site
city: Valreas
country: France
facility: Research Site
city: Vihiers
country: France
facility: Research Site
city: Vénissieux
country: France
facility: Research Site
city: Aschaffenburg
country: Germany
facility: Research Site
city: Dresden
country: Germany
facility: Research Site
city: Eisenach
country: Germany
facility: Research Site
city: Essen Schonnebeck
country: Germany
facility: Research Site
city: Essen
country: Germany
facility: Research Site
city: Falkensee
country: Germany
facility: Research Site
city: Fulda
country: Germany
facility: Research Site
city: Hamburg-Altona
country: Germany
facility: Research Site
city: Hamburg-Ottmarschen
country: Germany
facility: Research Site
city: Hamburg
country: Germany
facility: Research Site
city: Heidelberg
country: Germany
facility: Research Site
city: Leipzig
country: Germany
facility: Research Site
city: Munster
country: Germany
facility: Research Site
city: Saarbrucken
country: Germany
facility: Research Site
city: Schenklengsfeld
country: Germany
facility: Research Site
city: Schkeuditz
country: Germany
facility: Research Site
city: St. Ingbert
country: Germany
facility: Research Site
city: Staffelstein
country: Germany
facility: Research Site
city: Witten
country: Germany
facility: Research Site
city: Budapest
country: Hungary
facility: Research Site
city: Gyula
country: Hungary
facility: Research Site
city: Kecskemet
country: Hungary
facility: Research Site
city: Veszprem
country: Hungary
facility: Research Site
city: Zalaegerszeg
country: Hungary
facility: Research Site
city: County Galway
country: Ireland
facility: Research Site
city: County Waterford
country: Ireland
facility: Research Site
city: Dublin
country: Ireland
facility: Research Site
city: Haifa
country: Israel
facility: Research Site
city: Holon
country: Israel
facility: Research Site
city: Jerusalem
country: Israel
facility: Research Site
city: Tel Hashomer
country: Israel
facility: Research Site
city: Ancona
country: Italy
facility: Research Site
city: Arenzano
country: Italy
facility: Research Site
city: Atri
country: Italy
facility: Research Site
city: Bergamo
country: Italy
facility: Research Site
city: Catanzaro
country: Italy
facility: Research Site
city: Firenze
country: Italy
facility: Research Site
city: Foggia
country: Italy
facility: Research Site
city: Forli
country: Italy
facility: Research Site
city: Genova
country: Italy
facility: Research Site
city: Grosseto
country: Italy
facility: Research Site
city: Milano
country: Italy
facility: Research Site
city: Monserrato (Cagliari)
country: Italy
facility: Research Site
city: Napoli
country: Italy
facility: Research Site
city: Palermo
country: Italy
facility: Research Site
city: Perugia
country: Italy
facility: Research Site
city: Pescara
country: Italy
facility: Research Site
city: Pisa
country: Italy
facility: Research Site
city: Ravenna
country: Italy
facility: Research Site
city: Roma
country: Italy
facility: Research Site
city: San Benedetto del Tronto
country: Italy
facility: Research Site
city: Siena
country: Italy
facility: Research Site
city: Treviso
country: Italy
facility: Research Site
city: Verona
country: Italy
facility: Research Site
city: Mexico City
country: Mexico
facility: Research Site
state: Distrito Federal
city: Celaya
country: Mexico
facility: Research Site
state: Guanajuato
city: Pachuca
country: Mexico
facility: Research Site
state: Hidalgo
city: Monterrey
country: Mexico
facility: Research Site
state: Nuevo Leon
city: Bialystok
country: Poland
facility: Research Site
city: Bydgoszcz
country: Poland
facility: Research Site
city: Lublin
country: Poland
facility: Research Site
city: Szczecin
country: Poland
facility: Research Site
city: Warszawa
country: Poland
facility: Research Site
city: Wroclaw
country: Poland
facility: Research Site
city: Barcelona
country: Spain
facility: Research Site
city: Madrid
country: Spain
facility: Research Site
city: Fribourg
country: Switzerland
facility: Research Site
city: Geneva
country: Switzerland
facility: Research Site
city: Geneve
country: Switzerland
facility: Research Site
city: Lausanne
country: Switzerland
facility: Research Site
city: Luzern
country: Switzerland
facility: Research Site
city: Bath
country: United Kingdom
facility: Research Site
city: Belfast
country: United Kingdom
facility: Research Site
city: Brandford on Avon
country: United Kingdom
facility: Research Site
city: County Antrim
country: United Kingdom
facility: Research Site
city: Downpatrick
country: United Kingdom
facility: Research Site
city: Frome
country: United Kingdom
facility: Research Site
city: Midsomer Norton
country: United Kingdom
facility: Research Site
city: Omagh
country: United Kingdom
facility: Research Site
city: Penzance
country: United Kingdom
facility: Research Site
city: Plymouth
country: United Kingdom
facility: Research Site
city: Southdown
country: United Kingdom
facility: Research Site
city: Wiltshire
country: United Kingdom
facility: Research Site
Study officials:
affiliation: Eli Lilly and Company
name: James Malone, MD
role: STUDY_DIRECTOR
References:
citation: 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.
citation: 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.
citation: 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.