Exenatide Versus Glimepiride in Patients With Type 2 Diabetes

August 17, 2015 updated by: AstraZeneca

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

1029

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Austria
      • Graz, Austria
        • Research Site
      • Innsbruck, Austria
        • Research Site
      • Salzburg, Austria
        • Research Site
      • Vienna, Austria
        • Research Site
  • Czech Republic
      • Beroun, Czech Republic
        • Research Site
      • Ceske Budejovice, Czech Republic
        • Research Site
      • Hradec Kralove, Czech Republic
        • Research Site
      • Liberec, Czech Republic
        • Research Site
      • Pisek, Czech Republic
        • Research Site
      • Praha, Czech Republic
        • Research Site
      • Trebic, Czech Republic
        • Research Site
  • Finland
      • Helsinki, Finland
        • Research Site
      • Kuopio, Finland
        • Research Site
      • Pori, Finland
        • Research Site
      • Vaasa, Finland
        • Research Site
  • France
      • Alencon, France
        • Research Site
      • Bois-Guillaume, France
        • Research Site
      • Bourg des Comptes, France
        • Research Site
      • Broglie, France
        • Research Site
      • Bron, France
        • Research Site
      • Fleville Devant Nancy, France
        • Research Site
      • Le Creusot, France
        • Research Site
      • Le Mans, France
        • Research Site
      • Loudun, France
        • Research Site
      • Montigny les Metz, France
        • Research Site
      • Nevers, France
        • Research Site
      • Strasbourg, France
        • Research Site
      • Thouars, France
        • Research Site
      • Tours, France
        • Research Site
      • Valreas, France
        • Research Site
      • Vihiers, France
        • Research Site
      • Vénissieux, France
        • Research Site
  • Germany
      • Aschaffenburg, Germany
        • Research Site
      • Dresden, Germany
        • Research Site
      • Eisenach, Germany
        • Research Site
      • Essen, Germany
        • Research Site
      • Essen Schonnebeck, Germany
        • Research Site
      • Falkensee, Germany
        • Research Site
      • Fulda, Germany
        • Research Site
      • Hamburg, Germany
        • Research Site
      • Hamburg-Altona, Germany
        • Research Site
      • Hamburg-Ottmarschen, Germany
        • Research Site
      • Heidelberg, Germany
        • Research Site
      • Leipzig, Germany
        • Research Site
      • Munster, Germany
        • Research Site
      • Saarbrucken, Germany
        • Research Site
      • Schenklengsfeld, Germany
        • Research Site
      • Schkeuditz, Germany
        • Research Site
      • St. Ingbert, Germany
        • Research Site
      • Staffelstein, Germany
        • Research Site
      • Witten, Germany
        • Research Site
  • Hungary
      • Budapest, Hungary
        • Research Site
      • Gyula, Hungary
        • Research Site
      • Kecskemet, Hungary
        • Research Site
      • Veszprem, Hungary
        • Research Site
      • Zalaegerszeg, Hungary
        • Research Site
  • Ireland
      • County Galway, Ireland
        • Research Site
      • County Waterford, Ireland
        • Research Site
      • Dublin, Ireland
        • Research Site
  • Israel
      • Haifa, Israel
        • Research Site
      • Holon, Israel
        • Research Site
      • Jerusalem, Israel
        • Research Site
      • Tel Hashomer, Israel
        • Research Site
  • Italy
      • Ancona, Italy
        • Research Site
      • Arenzano, Italy
        • Research Site
      • Atri, Italy
        • Research Site
      • Bergamo, Italy
        • Research Site
      • Catanzaro, Italy
        • Research Site
      • Firenze, Italy
        • Research Site
      • Foggia, Italy
        • Research Site
      • Forli, Italy
        • Research Site
      • Genova, Italy
        • Research Site
      • Grosseto, Italy
        • Research Site
      • Milano, Italy
        • Research Site
      • Monserrato (Cagliari), Italy
        • Research Site
      • Napoli, Italy
        • Research Site
      • Palermo, Italy
        • Research Site
      • Perugia, Italy
        • Research Site
      • Pescara, Italy
        • Research Site
      • Pisa, Italy
        • Research Site
      • Ravenna, Italy
        • Research Site
      • Roma, Italy
        • Research Site
      • San Benedetto del Tronto, Italy
        • Research Site
      • Siena, Italy
        • Research Site
      • Treviso, Italy
        • Research Site
      • Verona, Italy
        • Research Site
  • Mexico
    • Distrito Federal
      • Mexico City, Distrito Federal, Mexico
        • Research Site
    • Guanajuato
      • Celaya, Guanajuato, Mexico
        • Research Site
    • Hidalgo
      • Pachuca, Hidalgo, Mexico
        • Research Site
    • Nuevo Leon
      • Monterrey, Nuevo Leon, Mexico
        • Research Site
  • Poland
      • Bialystok, Poland
        • Research Site
      • Bydgoszcz, Poland
        • Research Site
      • Lublin, Poland
        • Research Site
      • Szczecin, Poland
        • Research Site
      • Warszawa, Poland
        • Research Site
      • Wroclaw, Poland
        • Research Site
  • Spain
      • Barcelona, Spain
        • Research Site
      • Madrid, Spain
        • Research Site
  • Switzerland
      • Fribourg, Switzerland
        • Research Site
      • Geneva, Switzerland
        • Research Site
      • Geneve, Switzerland
        • Research Site
      • Lausanne, Switzerland
        • Research Site
      • Luzern, Switzerland
        • Research Site
  • United Kingdom
      • Bath, United Kingdom
        • Research Site
      • Belfast, United Kingdom
        • Research Site
      • Brandford on Avon, United Kingdom
        • Research Site
      • County Antrim, United Kingdom
        • Research Site
      • Downpatrick, United Kingdom
        • Research Site
      • Frome, United Kingdom
        • Research Site
      • Midsomer Norton, United Kingdom
        • Research Site
      • Omagh, United Kingdom
        • Research Site
      • Penzance, United Kingdom
        • Research Site
      • Plymouth, United Kingdom
        • Research Site
      • Southdown, United Kingdom
        • Research Site
      • Wiltshire, United Kingdom
        • Research Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 85 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Exenatide
Drug: exenatide
subcutaneous injection (5mcg or 10mcg), twice a day
Other Names:
  • Byetta
Active Comparator: Glimepiride
Drug: glimepiride
oral tablet (titrated to maximally tolerated dose), once daily
Other Names:
  • Amaryl

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of Patients With Treatment Failure
Time Frame: Baseline to end of Period II (up to 4.5 years)
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.
Baseline to end of Period II (up to 4.5 years)
Time to Treatment Failure
Time Frame: Baseline to end of Period II (up to 4.5 years)
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.
Baseline to end of Period II (up to 4.5 years)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Homeostasis Model Assessment of Beta-cell Function (HOMA-B) at Year 3
Time Frame: Year 3 in Period II
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).
Year 3 in Period II
Change in HOMA-B From Baseline to Endpoint
Time Frame: Baseline, end of Period II (up to 4.5 years)
Change in HOMA-B from baseline to endpoint.
Baseline, end of Period II (up to 4.5 years)
Fasting Proinsulin/Insulin Ratio at Year 3
Time Frame: Year 3 in Period II
Fasting proinsulin (measured in pmol/L)/insulin (measured in pmol/L) ratio at Year 3.
Year 3 in Period II
Change in Fasting Proinsulin/Insulin Ratio From Baseline to Endpoint.
Time Frame: Baseline, end of Period II (up to 4.5 years)
Change in fasting proinsulin (measured in pmol/L)/insulin (measured in pmol/L) ratio from baseline to endpoint.
Baseline, end of Period II (up to 4.5 years)
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
Time Frame: Year 3 in Period II
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).
Year 3 in Period II
Change in DI30/DG30 Ratio From Baseline to Endpoint
Time Frame: Baseline, end of Period II (up to 4.5 years)
Change in DI30/DG30 ratio from baseline to endpoint.
Baseline, end of Period II (up to 4.5 years)
Disposition Index at Year 3
Time Frame: Year 3 in Period II
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).
Year 3 in Period II
Change in Disposition Index From Baseline to Endpoint
Time Frame: Baseline, end of Period II (up to 4.5 years)
Change in disposition index from baseline to endpoint.
Baseline, end of Period II (up to 4.5 years)
Change in HbA1c From Baseline to Year 3
Time Frame: Baseline, Year 3 in Period II
Change in HbA1c from baseline to Year 3.
Baseline, Year 3 in Period II
Change in HbA1c From Baseline to Endpoint
Time Frame: Baseline, end of Period II (up to 4.5 years)
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).
Baseline, end of Period II (up to 4.5 years)
Fasting Plasma Glucose at Year 3
Time Frame: Year 3 in Period II
Fasting plasma glucose at Year 3.
Year 3 in Period II
Change in Fasting Plasma Glucose From Baseline to Endpoint
Time Frame: Baseline, end of Period II (up to 4.5 years)
Change in fasting plasma glucose from baseline to endpoint.
Baseline, end of Period II (up to 4.5 years)
Postprandial (2 Hours) Plasma Glucose at Year 3
Time Frame: Year 3 in Period II
Postprandial (2 hours) plasma glucose at Year 3.
Year 3 in Period II
Change in Postprandial (2 Hours) Plasma Glucose From Baseline to Endpoint
Time Frame: Baseline, end of Period II (up to 4.5 years)
Change from baseline in postprandial (2 hours) plasma glucose to endpoint.
Baseline, end of Period II (up to 4.5 years)
Change in Body Weight From Baseline to Year 3
Time Frame: Baseline, Year 3 in Period II
Change in Body weight from baseline to Year 3.
Baseline, Year 3 in Period II
Systolic Blood Pressure at Year 3
Time Frame: Year 3 in Period II
Systolic Blood pressure at Year 3.
Year 3 in Period II
Diastolic Blood Pressure at Year 3
Time Frame: Year 3 in Period II
Diastolic Blood pressure at Year 3.
Year 3 in Period II
Heart Rate at Year 3
Time Frame: Year 3 in Period II
Heart rate at Year 3.
Year 3 in Period II
Triglycerides at Year 3
Time Frame: Year 3 in Period II
Triglycerides at Year 3.
Year 3 in Period II
Total Cholesterol at Year 3
Time Frame: Year 3 in Period II
Total Cholesterol at Year 3.
Year 3 in Period II
High-density Lipoprotein (HDL) Cholesterol at Year 3
Time Frame: Year 3 in Period II
HDL Cholesterol at Year 3.
Year 3 in Period II
Hypoglycemia Rate Per Year
Time Frame: Baseline to end of Period II (up to 4.5 years)
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.
Baseline to end of Period II (up to 4.5 years)
Change in HbA1c From Baseline to Year 2 for Patients Randomized at Entry in Period III
Time Frame: Baseline in Period III, Year 2 in Period III
Change in HbA1c from baseline to Year 2.
Baseline in Period III, Year 2 in Period III
Change in HbA1c From Baseline to Year 2 for Patients Not Randomized at Entry in Period III
Time Frame: Baseline in Period III, Year 2 in Period III
Change in HbA1c from baseline to Year 2.
Baseline in Period III, Year 2 in Period III
Hypoglycemia Rate Per Year in Period III
Time Frame: Start of Period III to end of study
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.
Start of Period III to end of study

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

AstraZeneca

Collaborators

Eli Lilly and Company

Investigators

  • Study Director: James Malone, MD, Eli Lilly and Company

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2006

Primary Completion (Actual)

March 1, 2011

Study Completion (Actual)

March 1, 2011

Study Registration Dates

First Submitted

July 31, 2006

First Submitted That Met QC Criteria

July 31, 2006

First Posted (Estimate)

August 2, 2006

Study Record Updates

Last Update Posted (Estimate)

September 15, 2015

Last Update Submitted That Met QC Criteria

August 17, 2015

Last Verified

August 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • H8O-EW-GWBE

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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