GLP-1 Peptide Atlas, by Delfa

CompletedResults posted

Exenatide and Basal Insulins Use in the Real Setting: an Observational Study in Patients With Type 2 Diabetes

EBIRIOS - Exenatide and Basal Insulins Use in the Real Setting: an Italian Observational Study in Patients With Type 2 Diabetes and Secondary Failure of Oral Antihyperglycemic Treatment

Lead sponsor

AstraZeneca

Asset

Exenatide

Subcutaneous · GLP-1 agonist

Listed sites

Recruiting sites

—

Enrollment

888

actual

Study population

Type 2 diabetes

Key I/E criterion

•HbA1c ≥7%

Primary endpoint

•HbA1c <7.0% achievement

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 IDNCT01060059

Org study IDH8O-IT-B014

Timeline

Milestones

Study first posted2010-02-02estimated

Results first posted2014-01-16estimated

Last update posted2015-04-09estimated

Study start2010-04 (month precision)

Primary completion2012-05actual (month precision)

Study completion2012-05actual (month precision)

Assets

Investigational agents

Exenatide

Study populations

Who this study enrolls

Type 2 diabetes

Eligibility

Who can enroll

Minimum age18 Years

SexAll

Healthy volunteersNot accepted

Sampling methodProbability sample

Study population text

The targeted population consists of adult patients with type 2 diabetes mellitus treated in outpatient setting by specialists.

Eligibility criteria

1. Are inadequately controlled with single or multiple OHA as evidenced by an HbA1c > 7.0%

2. Have presented during the routine course of care and, together with their physician, have decided to initiate treatment with either exenatide twice daily or conventional insulin therapy with basal insulin (insulin glargine, detemir, protaminated insulin lispro, protaminated human insulin) added to the existing treatment with OHA

3. Have not been treated with GLP-1 receptor agonist for more than 7 consecutive days within 3 months before entering the study

4. Have not been treated with insulins for more than 7 consecutive days within last 3 months or more than 3 months in the course of the disease

5. Are not simultaneously participating in another study which includes an investigational drug or procedure at study entry

6. Have been fully informed and given their written consent for use of their data

Endpoints (23)

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

Weight & body composition

Other clinical outcomes

Safety / tolerability / PK

Weight & body composition

4 endpoints

Secondary/protocol endpoint

Changes in Weight From Baseline to Month 12

Time frame:Baseline, Month 12

Body weight, absolute change (kg)

change from baseline, improvement

Posted result

Group	Value (mean), kg	95% CI
Exenatide	-3.9	—
Basal Insulin	0.2	—

Secondary/protocol endpoint

Percentage of Patients Achieving a Weight Decrease >=3% Between Baseline and Month 12

Time frame:Baseline, Month 12

threshold achievement, improvement

Posted result

Group	Value (number), percentage of patients	95% CI
Exenatide	43.0	—
Basal Insulin	17.6	—

Secondary/protocol endpoint

Percentage of Patients Achieving a Weight Decrease >=5% Between Baseline and Month 12

Time frame:Baseline, Month 12

≥5% weight-loss responders

threshold achievement, improvement

Posted result

Group	Value (number), percentage of patients	95% CI
Exenatide	29.7	—
Basal Insulin	10.7	—

Secondary/protocol endpoint

Factor of Higher Body Mass Index (BMI) Associated With Treatment Choice at Baseline

Time frame:baseline

descriptive

Posted result

Group	Value (mean), kg/m^2	95% CI
Exenatide	35.4	—
Basal Insulin	29.4	—

Odds Ratio (OR)1.1995% CI1.15 – 1.23p<0.001Regression, Logistic

Glycemic / diabetes

8 endpoints

Primary/protocol endpoint

Percentage of Patients Who Achieved Glycemic Target of HbA1c ≤ 7.0% With Minimal Weight Gain (≤ 1 Kg) at Month 12.

Time frame:Baseline, Month 12

HbA1c <7.0% achievement

threshold achievement, improvement

LOINC 4548-4

Posted result

Group	Value (number), percentage of patients	95% CI
Exenatide	35.0	30.32 – 39.93
Basal Insulin	15.8	12.39 – 19.73

Secondary/protocol endpoint

Changes in HbA1c From Baseline to Month 12

Time frame:Baseline, Month 12

HbA1c, change

change from baseline, improvement

LOINC 4548-4

Posted result

Group	Value (mean), percent	95% CI
Exenatide	-1.1	—
Basal Insulin	-1.4	—

Secondary/protocol endpoint

Changes in Fasting Blood Glucose From Baseline to Month 12

Time frame:Baseline, Month 12

Fasting glucose, change

change from baseline, improvement

LOINC 1558-6

Posted result

Group	Value (mean), mg/dL	95% CI
Exenatide	-26.7	—
Basal Insulin	-51.4	—

Secondary/protocol endpoint

Percentage of Patients With HbA1c Reduction From Baseline >= 1.0% at Month 12

Time frame:Baseline, Month 12

threshold achievement, improvement

LOINC 4548-4

Posted result

Group	Value (number), percentage of patients	95% CI
Exenatide	49.4	—
Basal Insulin	51.1	—

Secondary/protocol endpoint

Percentage of Patients Achieving HbA1c Concentration <=7.0% at Month 12

Time frame:Month 12

HbA1c <7.0% achievement

threshold achievement, improvement

LOINC 4548-4

Posted result

Group	Value (number), percentage of patients	95% CI
Exenatide	39.0	—
Basal Insulin	22.2	—

Secondary/protocol endpoint

Percentage of Patients Achieving HbA1c Concentration <6.5% at Month 12

Time frame:Month 12

HbA1c <6.5% achievement

threshold achievement, improvement

LOINC 4548-4

Posted result

Group	Value (number), percentage of patients	95% CI
Exenatide	13.1	—
Basal Insulin	4.9	—

Secondary/protocol endpoint

Factor of 1 Percent (%) Higher Baseline HbA1c Associated With Treatment Choice at Baseline

Time frame:baseline

HbA1c baseline OR

ratio, descriptive

LOINC 4548-4

Posted result

Group	Value (mean), Percentage of normal	95% CI
Exenatide	8.7	—
Basal Insulin	9.2	—

Odds Ratio (OR)0.6995% CI0.60 – 0.78p<0.001Regression, Logistic

Secondary/protocol endpoint

Factor of Longer Duration of Diabetes Associated With Treatment Choice at Baseline

Time frame:baseline

descriptive

Posted result

Group	Value (mean), years	95% CI
Exenatide	9.0	—
Basal Insulin	12.4	—

Odds Ratio (OR)0.9895% CI0.96 – 1.00p0.055Regression, Logistic

Cardiometabolic biomarkers

7 endpoints

Secondary/protocol endpoint

Changes in Fasting Total Cholesterol Between Baseline and Month 12

Time frame:Baseline, Month 12

Total cholesterol, change

change from baseline, improvement

LOINC 2093-3

Posted result

Group	Value (mean), mg/dL	95% CI
Exenatide	-6.0	—
Basal Insulin	-7.5	—

Secondary/protocol endpoint

Changes in Fasting HDL Between Baseline and Month 12

Time frame:Baseline, Month 12

HDL-C, change

change from baseline, improvement

LOINC 2085-9

Posted result

Group	Value (mean), mg/dL	95% CI
Exenatide	1.3	—
Basal Insulin	0.2	—

Secondary/protocol endpoint

Changes in Fasting LDL Between Baseline and Month 12

Time frame:Baseline, Month 12

LDL-C, change

change from baseline, improvement

LOINC 13457-7

Posted result

Group	Value (mean), mg/dL	95% CI
Exenatide	-4.6	—
Basal Insulin	-4.5	—

Secondary/protocol endpoint

Changes in Fasting Triglycerides Between Baseline and Month 12

Time frame:Baseline, Month 12

Triglycerides, change

change from baseline, improvement

LOINC 2571-8

Posted result

Group	Value (mean), mg/dL	95% CI
Exenatide	-16.5	—
Basal Insulin	-30.2	—

Secondary/protocol endpoint

Changes in Diastolic Blood Pressure Between Baseline and Month 12

Time frame:Baseline, Month 12

Diastolic BP, change

change from baseline, improvement

LOINC 8462-4

Posted result

Group	Value (mean), mmHg	95% CI
Exenatide	-2.4	—
Basal Insulin	0.2	—

Secondary/protocol endpoint

Changes in Systolic Blood Pressure Between Baseline and Month 12

Time frame:Baseline, Month 12

Systolic BP, change

change from baseline, improvement

LOINC 8480-6

Posted result

Group	Value (mean), mmHg	95% CI
Exenatide	-4.6	—
Basal Insulin	-1.0	—

Secondary/protocol endpoint/low confidence

Factors of Higher Creatinine, Higher Fasting High Density Lipoprotein (HDL) Cholesterol, Higher Fasting Cholesterol, and Higher Fasting Triglycerides Which Were Associated With Treatment Choice at Baseline

Time frame:baseline

descriptive

Posted result

Group	Value (mean), mg/dL	95% CI
ExenatideCreatinine (N=324, 333)	0.9	—
HDL (N=335, 326)	44.7	—
Total Cholesterol (N=368, 355)	181.1	—
Triglycerides (N=364, 360)	177.5	—
Basal InsulinCreatinine (N=324, 333)	1.0	—
HDL (N=335, 326)	46.9	—
Total Cholesterol (N=368, 355)	182.7	—
Triglycerides (N=364, 360)	173.6	—

Odds Ratio (OR)0.3795% CI0.18 – 0.77p0.007Regression, Logistic

Odds Ratio (OR)0.9995% CI0.97 – 1.00p0.094Regression, Logistic

Odds Ratio (OR)1.0095% CI1.00 – 1.01p0.259Regression, Logistic

Odds Ratio (OR)1.0095% CI1.00 – 1.00p0.123Regression, Logistic

Safety / tolerability / PK

1 endpoint

Secondary/protocol endpoint

Percentage of Patients With Hypoglycemia Episodes Between Baseline and Month 12

Time frame:Baseline to Month 12

Documented hypoglycemia

threshold achievement, event

Posted result

Group	Value (number), percentage of patients	95% CI
Exenatide	3.6	—
Basal Insulin	8.2	—

Other clinical outcomes

3 endpoints

Secondary/protocol endpoint

Factors of Gender, Baseline Presence of Medical Conditions, and Previous Gastrointestinal Symptoms Associated With Treatment Choice at Baseline

Time frame:baseline

descriptive

Posted result

Group	Value (number), participants	95% CI
ExenatideMale Gender	246	0.62 – 1.46
Female Gender	198	—
Medical conditions present	371	0.74 – 1.76
No medical conditions	73	—
Previous gastrointestinal symptoms present	8	0.43 – 3.42
No gastrointestinal symptoms	436	—
Basal InsulinMale Gender	247	—
Female Gender	191	—
Medical conditions present	363	—
No medical conditions	75	—
Previous gastrointestinal symptoms present	11	—
No gastrointestinal symptoms	427	—

Odds Ratio (OR)0.9595% CI0.62 – 1.46p0.831Regression, Logistic

Odds Ratio (OR)1.1495% CI0.74 – 1.76p0.554Regression, Logistic

Odds Ratio (OR)1.2195% CI0.43 – 3.42p0.714Regression, Logistic

Secondary/protocol endpoint

Factor of Older Age Associated With Treatment Choice at Baseline

Time frame:baseline

categorical status, descriptive

Posted result

Group	Value (mean), years	95% CI
Exenatide	59.2	—
Basal Insulin	65.9	—

Odds Ratio (OR)0.9795% CI0.95 – 0.99p<0.001Regression, Logistic

Secondary/protocol endpoint

Factor of Greater Height Associated With Treatment Choice at Baseline

Time frame:baseline

descriptive

Posted result

Group	Value (mean), cm	95% CI
Exenatide	165.8	—
Basal Insulin	164.4	—

Odds Ratio (OR)1.0395% CI1.00 – 1.05p0.026Regression, Logistic

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.