Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

Exenatide Versus Glimepiride in Patients With Type 2 Diabetes

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00359762
Recruitment Status : Completed
First Posted : August 2, 2006
Results First Posted : March 14, 2013
Last Update Posted : September 15, 2015
Sponsor:
Collaborator:
Eli Lilly and Company
Information provided by (Responsible Party):
AstraZeneca

Study Description
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
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.

Condition or disease Intervention/treatment Phase
Type 2 Diabetes Mellitus Drug: exenatide Drug: glimepiride Phase 3

Study Design
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 1029 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Long Term Treatment With Exenatide Versus Glimepiride in Patients With Type 2 Diabetes Pretreated With Metformin (EUREXA: European Exenatide Study)
Study Start Date : September 2006
Actual Primary Completion Date : March 2011
Actual Study Completion Date : March 2011

Resource links provided by the National Library of Medicine


Arms and Interventions
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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


Outcome Measures
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. 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.

  2. 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.


Secondary Outcome Measures :
  1. 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).

  2. 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.

  3. 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.

  4. 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.

  5. 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).

  6. 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.

  7. 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).

  8. 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.

  9. Change in HbA1c From Baseline to Year 3 [ Time Frame: Baseline, Year 3 in Period II ]
    Change in HbA1c from baseline to Year 3.

  10. 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).

  11. Fasting Plasma Glucose at Year 3 [ Time Frame: Year 3 in Period II ]
    Fasting plasma glucose at Year 3.

  12. 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.

  13. Postprandial (2 Hours) Plasma Glucose at Year 3 [ Time Frame: Year 3 in Period II ]
    Postprandial (2 hours) plasma glucose at Year 3.

  14. 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.

  15. 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.

  16. Systolic Blood Pressure at Year 3 [ Time Frame: Year 3 in Period II ]
    Systolic Blood pressure at Year 3.

  17. Diastolic Blood Pressure at Year 3 [ Time Frame: Year 3 in Period II ]
    Diastolic Blood pressure at Year 3.

  18. Heart Rate at Year 3 [ Time Frame: Year 3 in Period II ]
    Heart rate at Year 3.

  19. Triglycerides at Year 3 [ Time Frame: Year 3 in Period II ]
    Triglycerides at Year 3.

  20. Total Cholesterol at Year 3 [ Time Frame: Year 3 in Period II ]
    Total Cholesterol at Year 3.

  21. High-density Lipoprotein (HDL) Cholesterol at Year 3 [ Time Frame: Year 3 in Period II ]
    HDL Cholesterol at Year 3.

  22. 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.

  23. 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.

  24. 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.

  25. 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.


Eligibility Criteria
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00359762


Locations
Show Show 115 study locations
Sponsors and Collaborators
AstraZeneca
Eli Lilly and Company
Investigators
Layout table for investigator information
Study Director: James Malone, MD Eli Lilly and Company
More Information
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Layout table for additonal information
Responsible Party: AstraZeneca
ClinicalTrials.gov Identifier: NCT00359762    
Other Study ID Numbers: H8O-EW-GWBE
First Posted: August 2, 2006    Key Record Dates
Results First Posted: March 14, 2013
Last Update Posted: September 15, 2015
Last Verified: August 2015
Keywords provided by AstraZeneca:
exenatide
diabetes
Amylin
Lilly
glimepiride
Additional relevant MeSH terms:
Layout table for MeSH terms
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Exenatide
Glimepiride
Hypoglycemic Agents
 Physiological Effects of Drugs
Anti-Obesity Agents
Incretins
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Anti-Arrhythmia Agents
Immunosuppressive Agents
Immunologic Factors