GLP-1 Peptide Atlas, by Delfa

CompletedPhase 3Results posted

Exenatide Versus Glimepiride in Patients With Type 2 Diabetes

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

Lead sponsor

AstraZeneca

Asset

Exenatide

Subcutaneous · GLP-1 agonist

Listed sites

114

Recruiting sites

—

Enrollment

1,029

actual

Study population

Obesity / overweight, Type 2 diabetes

Key I/E criteria

•BMI 25-40•HbA1c 6.5-9%

Primary endpoints

•Treatment Failure (HbA1c <7.0% achievement)•Treatment Failure

Footprint

Where this trial recruits

Site locations as reported to ClinicalTrials.gov. Site count is not enrollment count; per-site enrollment is not available from source.

Identifiers

Registered as

NCT IDNCT00359762

Org study IDH8O-EW-GWBE

Timeline

Milestones

Study first posted2006-08-02estimated

Results first posted2013-03-14estimated

Last update posted2015-09-15estimated

Study start2006-09 (month precision)

Primary completion2011-03actual (month precision)

Study completion2011-03actual (month precision)

Assets

Investigational agents

Exenatide

Study populations

Who this study enrolls

Obesity / overweightType 2 diabetes

Eligibility

Who can enroll

Minimum age18 Years

Maximum age85 Years

SexAll

Healthy volunteersNot accepted

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

Endpoints (27)

What's being measured

Protocol endpoints and posted registry outcome measures, grouped into outcome categories. Composite endpoints show their component event types. Standard codes (LOINC, SNOMED CT) are shown where available.

Coverage by outcome category

Glycemic / diabetes

Cardiometabolic biomarkers

Safety / tolerability / PK

Weight & body composition

1 endpoint

Secondary/protocol endpoint

Change in Body Weight From Baseline to Year 3

Time frame:Baseline, Year 3 in Period II

Body weight, absolute change (kg)

change from baseline, improvement

Posted result

Group	Value (least_squares_mean), kg	95% CI
Exen + Met	-3.92	—
Glim + Met	1.47	—

Least Squares Mean Difference-5.4095% CI-6.31 – -4.49p<.0001Mixed Models Analysis

MMRM analysis includes treatment, visit, and treatment by visit interaction and baseline value as a covariate. The unstructured covariance matrix was used.

Glycemic / diabetes

17 endpoints

Primary/protocol endpoint

Number of Patients With Treatment Failure

Time frame:Baseline to end of Period II (up to 4.5 years)

threshold achievement, event

componentsHbA1c <7.0% achievement

Posted result

Group	Value (number), number of patients	95% CI
Exen + MetNumber of patients with treatment failure	203	—
Number of patients censored	287	—
Glim + MetNumber of patients with treatment failure	262	—
Number of patients censored	225	—

Hazard Ratio0.74895% CI0.623 – 0.899p0.0020Regression, Cox

Primary/protocol endpoint

Time to Treatment Failure

Time frame:Baseline to end of Period II (up to 4.5 years)

time to event, event

Posted result

Group	Value (median), week	95% CI
Exen + Met	180.0	140.9 – NA
Glim + Met	142.1	118.6 – 161.1

p0.0315Log Rank

Kaplan-Meier survival curves for time to treatment failure were compared between treatment groups using log rank test.

Secondary/protocol endpoint

Homeostasis Model Assessment of Beta-cell Function (HOMA-B) at Year 3

Time frame:Year 3 in Period II

descriptive, improvement

Posted result

Group	Value (least_squares_mean), ratio	95% CI
Exen + Met	66.86	—
Glim + Met	68.52	—

Least Squares Mean Difference-1.6695% CI-12.58 – 9.25p0.7648Mixed Models Analysis

Mixed-model Repeated Measures (MMRM) analysis includes treatment, visit, and treatment by visit interaction, and baseline value as a covariate. The unstructured covariance matrix was used.

Secondary/protocol endpoint

Change in HOMA-B From Baseline to Endpoint

Time frame:Baseline, end of Period II (up to 4.5 years)

change from baseline, improvement

Posted result

Group	Value (least_squares_mean), ratio	95% CI
Exen + Met	5.56	—
Glim + Met	19.92	—

Least Squares Mean Difference-14.3595% CI-28.88 – 0.17p0.0528ANCOVA

Secondary/protocol endpoint

Fasting Proinsulin/Insulin Ratio at Year 3

Time frame:Year 3 in Period II

ratio, improvement

Posted result

Group	Value (least_squares_mean), ratio	95% CI
Exen + Met	0.22	—
Glim + Met	0.23	—

Least Squares Mean Difference-0.0095% CI-0.07 – 0.06p0.9040Mixed Models Analysis

MMRM analysis includes treatment, visit, and treatment by visit interaction, and baseline value as a covariate. The unstructured covariance matrix was used.

Secondary/protocol endpoint/low confidence

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

ratio, improvement

Posted result

Group	Value (least_squares_mean), ratio	95% CI
Exen + Met	25.81	—
Glim + Met	26.38	—

Least Squares Mean Difference-0.5695% CI-9.40 – 8.27p0.9001Mixed Models Analysis

MMRM analysis includes treatment, visit, and treatment by visit interaction, and baseline value as a covariate. The unstructured covariance matrix was used.

Secondary/protocol endpoint

Change in DI30/DG30 Ratio From Baseline to Endpoint

Time frame:Baseline, end of Period II (up to 4.5 years)

change from baseline, improvement

Posted result

Group	Value (least_squares_mean), ratio	95% CI
Exen + Met	12.10	—
Glim + Met	0.91	—

Least Squares Mean Difference11.1995% CI1.44 – 20.95p0.0246ANCOVA

Secondary/protocol endpoint/low confidence

Disposition Index at Year 3

Time frame:Year 3 in Period II

descriptive, improvement

Posted result

Group	Value (least_squares_mean), ratio	95% CI
Exen + Met	12.56	—
Glim + Met	7.89	—

Least Squares Mean Difference4.6795% CI1.53 – 7.81p0.0036Mixed Models Analysis

MMRM analysis includes treatment, visit, and treatment by visit interaction, and baseline value as a covariate. The unstructured covariance matrix was used.

Secondary/protocol endpoint

Change in Disposition Index From Baseline to Endpoint

Time frame:Baseline, end of Period II (up to 4.5 years)

change from baseline, improvement

Posted result

Group	Value (least_squares_mean), ratio	95% CI
Exen + Met	9.15	—
Glim + Met	1.82	—

Least Squares Mean Difference7.3395% CI3.15 – 11.50p0.0006ANCOVA

Secondary/protocol endpoint

Change in HbA1c From Baseline to Year 3

Time frame:Baseline, Year 3 in Period II

HbA1c, change

change from baseline, improvement

LOINC 4548-4

Posted result

Group	Value (least_squares_mean), percentage of total hemoglobin	95% CI
Exen + Met	-0.30	—
Glim + Met	-0.12	—

Least Squares Mean Difference-0.1895% CI-0.31 – -0.04p0.0128Mixed Models Analysis

MMRM analysis includes treatment, visit, and treatment by visit interaction, and baseline value as a covariate. The unstructured covariance matrix was used.

Secondary/protocol endpoint

Change in HbA1c From Baseline to Endpoint

Time frame:Baseline, end of Period II (up to 4.5 years)

HbA1c, change

change from baseline, improvement

LOINC 4548-4

Posted result

Group	Value (least_squares_mean), percentage of total hemoglobin	95% CI
Exen + Met	-0.36	—
Glim + Met	-0.21	—

Least Squares Mean Difference-0.1695% CI-0.26 – -0.06p0.0015ANCOVA

Change in HbA1c from baseline to endpoint was analyzed by an ANCOVA model that includes treatment as factor and baseline value as a covariate.

Secondary/protocol endpoint

Fasting Plasma Glucose at Year 3

Time frame:Year 3 in Period II

Fasting glucose, change

change from baseline, improvement

LOINC 1558-6

Posted result

Group	Value (least_squares_mean), mmol/L	95% CI
Exen + Met	7.27	—
Glim + Met	7.96	—

Least Squares Mean Difference-0.6995% CI-1.03 – -0.34p<.0001Mixed Models Analysis

MMRM includes treatment, visit, and treatment by visit interaction, and baseline value as a covariate. The unstructured covariance matrix was used.

Secondary/protocol endpoint

Change in Fasting Plasma Glucose From Baseline to Endpoint

Time frame:Baseline, end of Period II (up to 4.5 years)

Fasting glucose, change

change from baseline, improvement

LOINC 1558-6

Posted result

Group	Value (least_squares_mean), mmol/L	95% CI
Exen + Met	-0.87	—
Glim + Met	-0.41	—

Least Squares Mean Difference-0.4795% CI-0.83 – -0.11p0.0109ANCOVA

Secondary/protocol endpoint

Postprandial (2 Hours) Plasma Glucose at Year 3

Time frame:Year 3 in Period II

Postprandial glucose

descriptive, improvement

Posted result

Group	Value (least_squares_mean), mmol/L	95% CI
Exen + Met	12.65	—
Glim + Met	15.45	—

Least Squares Mean Difference-2.8095% CI-3.64 – -1.97p<.0001Mixed Models Analysis

MMRM analysis includes treatment, visit, and treatment by visit interaction, and baseline value as a covariate. The unstructured covariance matrix was used.

Secondary/protocol endpoint

Change in Postprandial (2 Hours) Plasma Glucose From Baseline to Endpoint

Time frame:Baseline, end of Period II (up to 4.5 years)

Postprandial glucose

change from baseline, improvement

Posted result

Group	Value (least_squares_mean), mmol/L	95% CI
Exen + Met	-2.72	—
Glim + Met	-0.53	—

Least Squares Mean Difference-2.1995% CI-2.84 – -1.55p<.0001ANCOVA

Secondary/protocol endpoint

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

HbA1c, change

change from baseline, improvement

LOINC 4548-4

Posted result

Group	Value (least_squares_mean), percentage of total hemoglobin	95% CI
Exen + Met + Glim - Randomized	-0.19	—
Exen + Met + Pio or Rosi - Randomized	-0.47	—

Least Squares Mean Difference0.2895% CI-0.00 – 0.55p0.0508Mixed Models Analysis

MMRM analysis includes treatment, visit, and treatment by visit interaction, and baseline value at Period III as a covariate. The compound symmetric covariance structure was assumed.

Secondary/protocol endpoint

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

HbA1c, change

change from baseline, improvement

LOINC 4548-4

Posted result

Group	Value (mean), percentage of total hemoglobin	95% CI
Glim + Met + Exen - Not Randomized	-0.47	—

Cardiometabolic biomarkers

7 endpoints

Secondary/protocol endpoint

Change in Fasting Proinsulin/Insulin Ratio From Baseline to Endpoint.

Time frame:Baseline, end of Period II (up to 4.5 years)

ratio, improvement

Posted result

Group	Value (least_squares_mean), ratio	95% CI
Exen + Met	0.03	—
Glim + Met	0.05	—

Least Squares Mean Difference-0.0295% CI-0.05 – 0.01p0.2500ANCOVA

Secondary/protocol endpoint

Systolic Blood Pressure at Year 3

Time frame:Year 3 in Period II

Systolic BP, change

change from baseline, improvement

LOINC 8480-6

Posted result

Group	Value (least_squares_mean), mmHg	95% CI
Exen + Met	130.58	—
Glim + Met	135.78	—

Least Squares Mean Difference-5.2095% CI-7.61 – -2.79p<.0001Mixed Models Analysis

MMRM analysis includes treatment, visit, and treatment by visit interaction, and baseline value as a covariate. The unstructured covariance matrix was used.

Secondary/protocol endpoint

Diastolic Blood Pressure at Year 3

Time frame:Year 3 in Period II

Diastolic BP, change

change from baseline, improvement

LOINC 8462-4

Posted result

Group	Value (least_squares_mean), mmHg	95% CI
Exen + Met	77.45	—
Glim + Met	79.16	—

Least Squares Mean Difference-1.7195% CI-3.18 – -0.24p0.0228Mixed Models Analysis

MMRM analysis includes treatment, visit, and treatment by visit interaction, and baseline value as a covariate. The unstructured covariance matrix was used.

Secondary/protocol endpoint

Heart Rate at Year 3

Time frame:Year 3 in Period II

Heart rate, change

change from baseline, improvement

Posted result

Group	Value (least_squares_mean), beats per minute	95% CI
Exen + Met	73.51	—
Glim + Met	74.23	—

Least Squares Mean Difference-0.7295% CI-2.30 – 0.86p0.3737Mixed Models Analysis

MMRM analysis includes treatment, visit, and visit by treatment interaction, and baseline value as a covariate. The unstructured covariance matrix was used.

Secondary/protocol endpoint

Triglycerides at Year 3

Time frame:Year 3 in Period II

Triglycerides, change

change from baseline, improvement

LOINC 2571-8

Posted result

Group	Value (least_squares_mean), mmol/L	95% CI
Exen + Met	1.69	—
Glim + Met	1.95	—

Least Squares Mean Difference-0.2695% CI-0.43 – -0.08p0.0042Mixed Models Analysis

MMRM analysis includes treatment, visit, and treatment by visit interaction, and baseline value as a covariate. The unstructured covariance matrix was used.

Secondary/protocol endpoint

Total Cholesterol at Year 3

Time frame:Year 3 in Period II

Total cholesterol, change

change from baseline, improvement

LOINC 2093-3

Posted result

Group	Value (least_squares_mean), mmol/L	95% CI
Exen + Met	4.77	—
Glim + Met	4.75	—

Least Squares Mean Difference0.0295% CI-0.13 – 0.18p0.7914Mixed Models Analysis

MMRM analysis includes treatment, visit, and treatment by visit interaction, and baseline value as a covariate. The unstructured covariance matrix was used.

Secondary/protocol endpoint

High-density Lipoprotein (HDL) Cholesterol at Year 3

Time frame:Year 3 in Period II

HDL-C, change

change from baseline, improvement

LOINC 2085-9

Posted result

Group	Value (least_squares_mean), mmol/L	95% CI
Exen + Met	1.31	—
Glim + Met	1.25	—

Least Squares Mean Difference0.0695% CI0.02 – 0.10p0.0011Mixed Models Analysis

MMRM analysis includes treatment, visit, and treatment by visit interaction, and baseline value as a covariate. The unstructured covariance matrix was used.

Safety / tolerability / PK

2 endpoints

Secondary/protocol endpoint

Hypoglycemia Rate Per Year

Time frame:Baseline to end of Period II (up to 4.5 years)

Documented hypoglycemia

event count, event

Posted result

Group	Value (least_squares_mean), events per subject-year	95% CI
Exen + Met	1.52	—
Glim + Met	5.32	—

Least Squares Mean Difference0.2995% CI0.22 – 0.37p<.0001Negative Binomial Model

Secondary/protocol endpoint

Hypoglycemia Rate Per Year in Period III

Time frame:Start of Period III to end of study

Documented hypoglycemia

event count, event

Posted result

Group	Value (mean), events per subject-year	95% CI
Exen + Metformin + Glim - Randomized	2.78	—
Exen + Met + Pio or Rosi - Randomized	0.60	—
Glim + Met + Exen - Not Randomized	4.62	—

Publications (3)

Bibliography

Records linked to this trial through ClinicalTrials.gov references, PubMed NCT search, and curated study seeds. 'Canonical' marks design/result papers; others are registry references or candidates.

Registry references + supporting bibliography

Long-term changes in cardiovascular risk markers during administration of exenatide twice daily or glimepiride: results from the European exenatide study.
Cardiovascular diabetology2015 Sep 4PMID26338040doi:10.1186/s12933-015-0279-zvia clinicaltrials gov reference derived + pubmed nct search
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, obesity & metabolism2015 Jul (month)PMID25846577doi:10.1111/dom.12471via clinicaltrials gov reference derived + pubmed nct search
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 (London, England)2012 Jun 16PMID22683137doi:10.1016/S0140-6736(12)60479-6via clinicaltrials gov reference derived + pubmed nct search

Provenance

Sources

Trial identity, design, statusClinicalTrials.gov API v2

Snapshot dateJuly 1, 2026

Endpoint classificationDelfa endpoint taxonomy v2 (May 13, 2026)

Results tableClinicalTrials.gov results section

Trial facts come from public ClinicalTrials.gov records. Endpoint categories are Delfa's classification of those records, not a ClinicalTrials.gov field. All figures reflect the July 1, 2026 snapshot.