Back to resultsExenatide Versus Glimepiride in Patients With Type 2 Diabetes
Primary Purpose
Type 2 Diabetes Mellitus
Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
exenatide
glimepiride
Sponsored by
About this trial
This is an interventional treatment trial for Type 2 Diabetes Mellitus focused on measuring exenatide, diabetes, Amylin, Lilly, glimepiride
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
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Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Exenatide
Glimepiride
Arm Description
Outcomes
Primary Outcome Measures
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.
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.
Secondary Outcome Measures
Homeostasis Model Assessment of Beta-cell Function (HOMA-B) at Year 3
HOMA-B at Year 3. HOMA-B is an index of beta-cell function and was calculated as: HOMA-B = (20 x fasting insulin (measured in pmol/L))/((fasting glucose (measured in mmol/L) - 3.5) x 7.175).
Change in HOMA-B From Baseline to Endpoint
Change in HOMA-B from baseline to endpoint.
Fasting Proinsulin/Insulin Ratio at Year 3
Fasting proinsulin (measured in pmol/L)/insulin (measured in pmol/L) ratio at Year 3.
Change in Fasting Proinsulin/Insulin Ratio From Baseline to Endpoint.
Change in fasting proinsulin (measured in pmol/L)/insulin (measured in pmol/L) ratio from baseline to endpoint.
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
DI30/DG30 at Year 3. DI30/DG30 ratio was calculated as (30 minute post prandial insulin - fasting insulin) (measured in pmol/L)/(30 minute post prandial glucose - fasting glucose) (measured in mmol/L).
Change in DI30/DG30 Ratio From Baseline to Endpoint
Change in DI30/DG30 ratio from baseline to endpoint.
Disposition Index at Year 3
Disposition Index at Year 3. Disposition index was calculated as (DI30/DG30 ratio)/(HOMA index for insulin resistance (HOMA-IR)); where HOMA-IR=(fasting insulin (measured in pmol/L) x fasting glucose (measured in mmol/L))/(22.5 x 7.175).
Change in Disposition Index From Baseline to Endpoint
Change in disposition index from baseline to endpoint.
Change in HbA1c From Baseline to Year 3
Change in HbA1c from baseline to Year 3.
Change in HbA1c From Baseline to Endpoint
Change in HbA1c from baseline to endpoint. Endpoint for HbA1c was defined as the HbA1c measured at the treatment failure for patients reaching primary endpoint and was the last observation in study period II for other patients (either followed until the end of the study period II or discontinuing the study).
Fasting Plasma Glucose at Year 3
Fasting plasma glucose at Year 3.
Change in Fasting Plasma Glucose From Baseline to Endpoint
Change in fasting plasma glucose from baseline to endpoint.
Postprandial (2 Hours) Plasma Glucose at Year 3
Postprandial (2 hours) plasma glucose at Year 3.
Change in Postprandial (2 Hours) Plasma Glucose From Baseline to Endpoint
Change from baseline in postprandial (2 hours) plasma glucose to endpoint.
Change in Body Weight From Baseline to Year 3
Change in Body weight from baseline to Year 3.
Systolic Blood Pressure at Year 3
Systolic Blood pressure at Year 3.
Diastolic Blood Pressure at Year 3
Diastolic Blood pressure at Year 3.
Heart Rate at Year 3
Heart rate at Year 3.
Triglycerides at Year 3
Triglycerides at Year 3.
Total Cholesterol at Year 3
Total Cholesterol at Year 3.
High-density Lipoprotein (HDL) Cholesterol at Year 3
HDL Cholesterol at Year 3.
Hypoglycemia Rate Per Year
All hypoglycemia episodes were taken into account. Severe hypoglycemia: event requiring assistance of another person to administer carbohydrate, glucagons, or other resuscitative actions; Documented symptomatic hypoglycemia: event with typical symptoms accompanied by a measured plasma glucose concentration <=70 mg/dL; Asymptomatic hypoglycemia: event not accompanied by typical symptoms but with a measured plasma glucose concentration <=70 mg/dL; Probable symptomatic hypoglycemia: event with symptoms not accompanied by a plasma glucose determination.
Change in HbA1c From Baseline to Year 2 for Patients Randomized at Entry in Period III
Change in HbA1c from baseline to Year 2.
Change in HbA1c From Baseline to Year 2 for Patients Not Randomized at Entry in Period III
Change in HbA1c from baseline to Year 2.
Hypoglycemia Rate Per Year in Period III
All hypoglycemia episodes were taken into account. Severe hypoglycemia: event requiring assistance of another person to administer carbohydrate, glucagons, or other resuscitative actions; Documented symptomatic hypoglycemia: event with typical symptoms accompanied by a measured plasma glucose concentration <=70 mg/dL; Asymptomatic hypoglycemia: event not accompanied by typical symptoms but with a measured plasma glucose concentration <=70 mg/dL; Probable symptomatic hypoglycemia: event with symptoms not accompanied by a plasma glucose determination.
Full Information
NCT ID
NCT00359762
First Posted
July 31, 2006
Last Updated
August 17, 2015
Sponsor
AstraZeneca
Collaborators
Eli Lilly and Company
1. Study Identification
Unique Protocol Identification Number
NCT00359762
Brief Title
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
2. Study Status
Record Verification Date
August 2015
Overall Recruitment Status
Completed
Study Start Date
September 2006 (undefined)
Primary Completion Date
March 2011 (Actual)
Study Completion Date
March 2011 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
AstraZeneca
Collaborators
Eli Lilly and Company
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Type 2 Diabetes Mellitus
Keywords
exenatide, diabetes, Amylin, Lilly, glimepiride
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
1029 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Exenatide
Arm Type
Experimental
Arm Title
Glimepiride
Arm Type
Active Comparator
Intervention Type
Drug
Intervention Name(s)
exenatide
Other Intervention Name(s)
Byetta
Intervention Description
subcutaneous injection (5mcg or 10mcg), twice a day
Intervention Type
Drug
Intervention Name(s)
glimepiride
Other Intervention Name(s)
Amaryl
Intervention Description
oral tablet (titrated to maximally tolerated dose), once daily
Primary Outcome Measure Information:
Title
Number of Patients With Treatment Failure
Description
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.
Time Frame
Baseline to end of Period II (up to 4.5 years)
Title
Time to Treatment Failure
Description
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.
Time Frame
Baseline to end of Period II (up to 4.5 years)
Secondary Outcome Measure Information:
Title
Homeostasis Model Assessment of Beta-cell Function (HOMA-B) at Year 3
Description
HOMA-B at Year 3. HOMA-B is an index of beta-cell function and was calculated as: HOMA-B = (20 x fasting insulin (measured in pmol/L))/((fasting glucose (measured in mmol/L) - 3.5) x 7.175).
Time Frame
Year 3 in Period II
Title
Change in HOMA-B From Baseline to Endpoint
Description
Change in HOMA-B from baseline to endpoint.
Time Frame
Baseline, end of Period II (up to 4.5 years)
Title
Fasting Proinsulin/Insulin Ratio at Year 3
Description
Fasting proinsulin (measured in pmol/L)/insulin (measured in pmol/L) ratio at Year 3.
Time Frame
Year 3 in Period II
Title
Change in Fasting Proinsulin/Insulin Ratio From Baseline to Endpoint.
Description
Change in fasting proinsulin (measured in pmol/L)/insulin (measured in pmol/L) ratio from baseline to endpoint.
Time Frame
Baseline, end of Period II (up to 4.5 years)
Title
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
Description
DI30/DG30 at Year 3. DI30/DG30 ratio was calculated as (30 minute post prandial insulin - fasting insulin) (measured in pmol/L)/(30 minute post prandial glucose - fasting glucose) (measured in mmol/L).
Time Frame
Year 3 in Period II
Title
Change in DI30/DG30 Ratio From Baseline to Endpoint
Description
Change in DI30/DG30 ratio from baseline to endpoint.
Time Frame
Baseline, end of Period II (up to 4.5 years)
Title
Disposition Index at Year 3
Description
Disposition Index at Year 3. Disposition index was calculated as (DI30/DG30 ratio)/(HOMA index for insulin resistance (HOMA-IR)); where HOMA-IR=(fasting insulin (measured in pmol/L) x fasting glucose (measured in mmol/L))/(22.5 x 7.175).
Time Frame
Year 3 in Period II
Title
Change in Disposition Index From Baseline to Endpoint
Description
Change in disposition index from baseline to endpoint.
Time Frame
Baseline, end of Period II (up to 4.5 years)
Title
Change in HbA1c From Baseline to Year 3
Description
Change in HbA1c from baseline to Year 3.
Time Frame
Baseline, Year 3 in Period II
Title
Change in HbA1c From Baseline to Endpoint
Description
Change in HbA1c from baseline to endpoint. Endpoint for HbA1c was defined as the HbA1c measured at the treatment failure for patients reaching primary endpoint and was the last observation in study period II for other patients (either followed until the end of the study period II or discontinuing the study).
Time Frame
Baseline, end of Period II (up to 4.5 years)
Title
Fasting Plasma Glucose at Year 3
Description
Fasting plasma glucose at Year 3.
Time Frame
Year 3 in Period II
Title
Change in Fasting Plasma Glucose From Baseline to Endpoint
Description
Change in fasting plasma glucose from baseline to endpoint.
Time Frame
Baseline, end of Period II (up to 4.5 years)
Title
Postprandial (2 Hours) Plasma Glucose at Year 3
Description
Postprandial (2 hours) plasma glucose at Year 3.
Time Frame
Year 3 in Period II
Title
Change in Postprandial (2 Hours) Plasma Glucose From Baseline to Endpoint
Description
Change from baseline in postprandial (2 hours) plasma glucose to endpoint.
Time Frame
Baseline, end of Period II (up to 4.5 years)
Title
Change in Body Weight From Baseline to Year 3
Description
Change in Body weight from baseline to Year 3.
Time Frame
Baseline, Year 3 in Period II
Title
Systolic Blood Pressure at Year 3
Description
Systolic Blood pressure at Year 3.
Time Frame
Year 3 in Period II
Title
Diastolic Blood Pressure at Year 3
Description
Diastolic Blood pressure at Year 3.
Time Frame
Year 3 in Period II
Title
Heart Rate at Year 3
Description
Heart rate at Year 3.
Time Frame
Year 3 in Period II
Title
Triglycerides at Year 3
Description
Triglycerides at Year 3.
Time Frame
Year 3 in Period II
Title
Total Cholesterol at Year 3
Description
Total Cholesterol at Year 3.
Time Frame
Year 3 in Period II
Title
High-density Lipoprotein (HDL) Cholesterol at Year 3
Description
HDL Cholesterol at Year 3.
Time Frame
Year 3 in Period II
Title
Hypoglycemia Rate Per Year
Description
All hypoglycemia episodes were taken into account. Severe hypoglycemia: event requiring assistance of another person to administer carbohydrate, glucagons, or other resuscitative actions; Documented symptomatic hypoglycemia: event with typical symptoms accompanied by a measured plasma glucose concentration <=70 mg/dL; Asymptomatic hypoglycemia: event not accompanied by typical symptoms but with a measured plasma glucose concentration <=70 mg/dL; Probable symptomatic hypoglycemia: event with symptoms not accompanied by a plasma glucose determination.
Time Frame
Baseline to end of Period II (up to 4.5 years)
Title
Change in HbA1c From Baseline to Year 2 for Patients Randomized at Entry in Period III
Description
Change in HbA1c from baseline to Year 2.
Time Frame
Baseline in Period III, Year 2 in Period III
Title
Change in HbA1c From Baseline to Year 2 for Patients Not Randomized at Entry in Period III
Description
Change in HbA1c from baseline to Year 2.
Time Frame
Baseline in Period III, Year 2 in Period III
Title
Hypoglycemia Rate Per Year in Period III
Description
All hypoglycemia episodes were taken into account. Severe hypoglycemia: event requiring assistance of another person to administer carbohydrate, glucagons, or other resuscitative actions; Documented symptomatic hypoglycemia: event with typical symptoms accompanied by a measured plasma glucose concentration <=70 mg/dL; Asymptomatic hypoglycemia: event not accompanied by typical symptoms but with a measured plasma glucose concentration <=70 mg/dL; Probable symptomatic hypoglycemia: event with symptoms not accompanied by a plasma glucose determination.
Time Frame
Start of Period III to end of study
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
James Malone, MD
Organizational Affiliation
Eli Lilly and Company
Official's Role
Study Director
Facility Information:
Facility Name
Research Site
City
Graz
Country
Austria
Facility Name
Research Site
City
Innsbruck
Country
Austria
Facility Name
Research Site
City
Salzburg
Country
Austria
Facility Name
Research Site
City
Vienna
Country
Austria
Facility Name
Research Site
City
Beroun
Country
Czech Republic
Facility Name
Research Site
City
Ceske Budejovice
Country
Czech Republic
Facility Name
Research Site
City
Hradec Kralove
Country
Czech Republic
Facility Name
Research Site
City
Liberec
Country
Czech Republic
Facility Name
Research Site
City
Pisek
Country
Czech Republic
Facility Name
Research Site
City
Praha
Country
Czech Republic
Facility Name
Research Site
City
Trebic
Country
Czech Republic
Facility Name
Research Site
City
Helsinki
Country
Finland
Facility Name
Research Site
City
Kuopio
Country
Finland
Facility Name
Research Site
City
Pori
Country
Finland
Facility Name
Research Site
City
Vaasa
Country
Finland
Facility Name
Research Site
City
Alencon
Country
France
Facility Name
Research Site
City
Bois-Guillaume
Country
France
Facility Name
Research Site
City
Bourg des Comptes
Country
France
Facility Name
Research Site
City
Broglie
Country
France
Facility Name
Research Site
City
Bron
Country
France
Facility Name
Research Site
City
Fleville Devant Nancy
Country
France
Facility Name
Research Site
City
Le Creusot
Country
France
Facility Name
Research Site
City
Le Mans
Country
France
Facility Name
Research Site
City
Loudun
Country
France
Facility Name
Research Site
City
Montigny les Metz
Country
France
Facility Name
Research Site
City
Nevers
Country
France
Facility Name
Research Site
City
Strasbourg
Country
France
Facility Name
Research Site
City
Thouars
Country
France
Facility Name
Research Site
City
Tours
Country
France
Facility Name
Research Site
City
Valreas
Country
France
Facility Name
Research Site
City
Vihiers
Country
France
Facility Name
Research Site
City
Vénissieux
Country
France
Facility Name
Research Site
City
Aschaffenburg
Country
Germany
Facility Name
Research Site
City
Dresden
Country
Germany
Facility Name
Research Site
City
Eisenach
Country
Germany
Facility Name
Research Site
City
Essen Schonnebeck
Country
Germany
Facility Name
Research Site
City
Essen
Country
Germany
Facility Name
Research Site
City
Falkensee
Country
Germany
Facility Name
Research Site
City
Fulda
Country
Germany
Facility Name
Research Site
City
Hamburg-Altona
Country
Germany
Facility Name
Research Site
City
Hamburg-Ottmarschen
Country
Germany
Facility Name
Research Site
City
Hamburg
Country
Germany
Facility Name
Research Site
City
Heidelberg
Country
Germany
Facility Name
Research Site
City
Leipzig
Country
Germany
Facility Name
Research Site
City
Munster
Country
Germany
Facility Name
Research Site
City
Saarbrucken
Country
Germany
Facility Name
Research Site
City
Schenklengsfeld
Country
Germany
Facility Name
Research Site
City
Schkeuditz
Country
Germany
Facility Name
Research Site
City
St. Ingbert
Country
Germany
Facility Name
Research Site
City
Staffelstein
Country
Germany
Facility Name
Research Site
City
Witten
Country
Germany
Facility Name
Research Site
City
Budapest
Country
Hungary
Facility Name
Research Site
City
Gyula
Country
Hungary
Facility Name
Research Site
City
Kecskemet
Country
Hungary
Facility Name
Research Site
City
Veszprem
Country
Hungary
Facility Name
Research Site
City
Zalaegerszeg
Country
Hungary
Facility Name
Research Site
City
County Galway
Country
Ireland
Facility Name
Research Site
City
County Waterford
Country
Ireland
Facility Name
Research Site
City
Dublin
Country
Ireland
Facility Name
Research Site
City
Haifa
Country
Israel
Facility Name
Research Site
City
Holon
Country
Israel
Facility Name
Research Site
City
Jerusalem
Country
Israel
Facility Name
Research Site
City
Tel Hashomer
Country
Israel
Facility Name
Research Site
City
Ancona
Country
Italy
Facility Name
Research Site
City
Arenzano
Country
Italy
Facility Name
Research Site
City
Atri
Country
Italy
Facility Name
Research Site
City
Bergamo
Country
Italy
Facility Name
Research Site
City
Catanzaro
Country
Italy
Facility Name
Research Site
City
Firenze
Country
Italy
Facility Name
Research Site
City
Foggia
Country
Italy
Facility Name
Research Site
City
Forli
Country
Italy
Facility Name
Research Site
City
Genova
Country
Italy
Facility Name
Research Site
City
Grosseto
Country
Italy
Facility Name
Research Site
City
Milano
Country
Italy
Facility Name
Research Site
City
Monserrato (Cagliari)
Country
Italy
Facility Name
Research Site
City
Napoli
Country
Italy
Facility Name
Research Site
City
Palermo
Country
Italy
Facility Name
Research Site
City
Perugia
Country
Italy
Facility Name
Research Site
City
Pescara
Country
Italy
Facility Name
Research Site
City
Pisa
Country
Italy
Facility Name
Research Site
City
Ravenna
Country
Italy
Facility Name
Research Site
City
Roma
Country
Italy
Facility Name
Research Site
City
San Benedetto del Tronto
Country
Italy
Facility Name
Research Site
City
Siena
Country
Italy
Facility Name
Research Site
City
Treviso
Country
Italy
Facility Name
Research Site
City
Verona
Country
Italy
Facility Name
Research Site
City
Mexico City
State/Province
Distrito Federal
Country
Mexico
Facility Name
Research Site
City
Celaya
State/Province
Guanajuato
Country
Mexico
Facility Name
Research Site
City
Pachuca
State/Province
Hidalgo
Country
Mexico
Facility Name
Research Site
City
Monterrey
State/Province
Nuevo Leon
Country
Mexico
Facility Name
Research Site
City
Bialystok
Country
Poland
Facility Name
Research Site
City
Bydgoszcz
Country
Poland
Facility Name
Research Site
City
Lublin
Country
Poland
Facility Name
Research Site
City
Szczecin
Country
Poland
Facility Name
Research Site
City
Warszawa
Country
Poland
Facility Name
Research Site
City
Wroclaw
Country
Poland
Facility Name
Research Site
City
Barcelona
Country
Spain
Facility Name
Research Site
City
Madrid
Country
Spain
Facility Name
Research Site
City
Fribourg
Country
Switzerland
Facility Name
Research Site
City
Geneva
Country
Switzerland
Facility Name
Research Site
City
Geneve
Country
Switzerland
Facility Name
Research Site
City
Lausanne
Country
Switzerland
Facility Name
Research Site
City
Luzern
Country
Switzerland
Facility Name
Research Site
City
Bath
Country
United Kingdom
Facility Name
Research Site
City
Belfast
Country
United Kingdom
Facility Name
Research Site
City
Brandford on Avon
Country
United Kingdom
Facility Name
Research Site
City
County Antrim
Country
United Kingdom
Facility Name
Research Site
City
Downpatrick
Country
United Kingdom
Facility Name
Research Site
City
Frome
Country
United Kingdom
Facility Name
Research Site
City
Midsomer Norton
Country
United Kingdom
Facility Name
Research Site
City
Omagh
Country
United Kingdom
Facility Name
Research Site
City
Penzance
Country
United Kingdom
Facility Name
Research Site
City
Plymouth
Country
United Kingdom
Facility Name
Research Site
City
Southdown
Country
United Kingdom
Facility Name
Research Site
City
Wiltshire
Country
United Kingdom
12. IPD Sharing Statement
Citations:
PubMed Identifier
26338040
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.
Results Reference
derived
PubMed Identifier
25846577
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.
Results Reference
derived
PubMed Identifier
22683137
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.
Results Reference
derived
Learn more about this trial
Exenatide Versus Glimepiride in Patients With Type 2 Diabetes
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