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Clinical Trials/NCT00359762
NCT00359762CompletedPhase 3

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

AstraZeneca1 site in 1 country1,029 target enrollmentStarted: September 2006Last updated:
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Conditions
Interventions
Drugs

Trial Snapshot

Phase
Phase 3
Status
Completed
Enrollment
1,029
Locations
1
Primary Endpoint
Number of Patients With Treatment Failure
Study OverviewStudy DesignEligibility CriteriaArms & InterventionsOutcomesInvestigatorsSitesRecords & IdentifiersSimilar Trials

Study Overview

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.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
None

Eligibility Criteria

Ages
18 Years to 85 Years (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

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

Arms & Interventions

Exenatide

Experimental

Intervention: exenatide (Drug)

Glimepiride

Active Comparator

Intervention: glimepiride (Drug)

Outcomes

Primary Outcomes

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.

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 Outcomes

  • Homeostasis Model Assessment of Beta-cell Function (HOMA-B) at Year 3(Year 3 in Period II)
  • Change in DI30/DG30 Ratio From Baseline to Endpoint(Baseline, end of Period II (up to 4.5 years))
  • Disposition Index at Year 3(Year 3 in Period II)
  • Triglycerides at Year 3(Year 3 in Period II)
  • Total Cholesterol at Year 3(Year 3 in Period II)
  • High-density Lipoprotein (HDL) Cholesterol at Year 3(Year 3 in Period II)
  • Hypoglycemia Rate Per Year(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(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(Baseline in Period III, Year 2 in Period III)
  • Hypoglycemia Rate Per Year in Period III(Start of Period III to end of study)
  • 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(Year 3 in Period II)
  • Change in Fasting Proinsulin/Insulin 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(Year 3 in Period II)
  • 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(Baseline, Year 3 in Period II)
  • Change in HbA1c From Baseline to Endpoint(Baseline, end of Period II (up to 4.5 years))
  • Fasting Plasma Glucose at Year 3(Year 3 in Period II)
  • 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(Year 3 in Period II)
  • Change in Postprandial (2 Hours) Plasma Glucose From Baseline to Endpoint(Baseline, end of Period II (up to 4.5 years))
  • Change in Body Weight From Baseline to Year 3(Baseline, Year 3 in Period II)
  • Systolic Blood Pressure at Year 3(Year 3 in Period II)
  • Diastolic Blood Pressure at Year 3(Year 3 in Period II)
  • Heart Rate at Year 3(Year 3 in Period II)

Investigators

Sponsor Class
Industry
Responsible Party
Sponsor

Study Sites (1)

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