GLP-1 Peptide Atlas, by Delfa

← Trials/Trial dossier/NCT01940770

Completed

Specific Clinical Experience Investigation for Long-term Use of Bydureon.

Specific Clinical Experience Investigation for Long-term Use of Bydureon Subcutaneous Injection 2 mg and Bydureon Subcutaneous Injection 2 mg PEN

Lead sponsor

AstraZeneca

Asset

Exenatide

GLP-1 agonist

Listed sites

Recruiting sites

—

Enrollment

1,137

actual

Study population

Type 2 diabetes

Key I/E criterion

—

Primary endpoint

•Treatment-emergent AEs (any)

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 IDNCT01940770

Org study IDD5551C00001

Secondary IDEUPAS18608ENCePP

Timeline

Milestones

Study first posted2013-09-12estimated

Study start2013-10-18actual

Primary completion2019-11-29actual

Study completion2019-11-29actual

Last update posted2020-07-20actual

Assets

Investigational agents

Exenatide

Study populations

Who this study enrolls

Type 2 diabetes

Eligibility

Who can enroll

SexAll

Healthy volunteersNot accepted

Sampling methodNon probability sample

Study population text

The patients with type 2 diabetes mellitus who will be given Bydureon for the first time and who inadequately respond to sulfonylurea, biuguanides, and/or thiazolidines (monotherapy or combination use) in addition to diet and exercise.

Inclusion criteria

- The patients with type 2 diabetes mellitus who inadequately respond to sulfonylurea, biuguanides, and/or thiazolidines (monotherapy or combination use) in addition to diet and exercise.

Exclusion criteria

•No past history of hypersensitivity to the components of Bydureon.

•Not the patient with diabetic ketoacidosis, diabetic coma/ precoma, and/ or type 1 diabetes mellitus.

•Bydureon will not be administered to the patient in an emergency situation such as severe infection and operation.

•Not the patient with severe renal impairment, including those receiving dialysis.

Endpoints (17)

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

Cardiometabolic biomarkers

Weight & body composition

Glycemic / diabetes

Safety / tolerability / PK

Weight & body composition

4 endpoints

Secondary/protocol endpoint

Mean change of weight

Time frame:from baseline up to 3 years

Body weight, absolute change (kg)

change from baseline, improvement

Secondary/protocol endpoint

Mean change of weight

Time frame:from baseline up to 3 years

Body weight, absolute change (kg)

change from baseline, improvement

Secondary/protocol endpoint

Mean change of weight

Time frame:from baseline up to 3 years

Body weight, absolute change (kg)

change from baseline, improvement

Secondary/protocol endpoint

Mean change of weight

Time frame:from baseline up to 3 years

Body weight, absolute change (kg)

change from baseline, improvement

Glycemic / diabetes

4 endpoints

Secondary/protocol endpoint

Mean change of HbA1c

Time frame:from baseline up to 3 years

HbA1c, change

change from baseline, improvement

LOINC 4548-4

Secondary/protocol endpoint

Mean change of HbA1c

Time frame:from baseline up to 3 years

HbA1c, change

change from baseline, improvement

LOINC 4548-4

Secondary/protocol endpoint

Mean change of HbA1c

Time frame:from baseline up to 3 years

HbA1c, change

change from baseline, improvement

LOINC 4548-4

Secondary/protocol endpoint

Mean change of HbA1c

Time frame:from baseline up to 3 years

HbA1c, change

change from baseline, improvement

LOINC 4548-4

Cardiometabolic biomarkers

8 endpoints

Secondary/protocol endpoint

Mean change of blood pressure

Time frame:from baseline up to 3 years

change from baseline, improvement

Secondary/protocol endpoint/low confidence

Mean change of lipid metabolism

Time frame:from baseline up to 3 years

change from baseline, improvement

Secondary/protocol endpoint

Mean change of blood pressure

Time frame:from baseline up to 3 years

change from baseline, improvement

Secondary/protocol endpoint

Mean change of blood pressure

Time frame:from baseline up to 3 years

change from baseline, improvement

Secondary/protocol endpoint/low confidence

Mean change of blood pressure

Time frame:from baseline up to 3 years

change from baseline, improvement

Secondary/protocol endpoint/low confidence

Mean change of lipid metabolism

Time frame:from baseline up to 3 years

change from baseline, improvement

Secondary/protocol endpoint/low confidence

Mean change of lipid metabolism

Time frame:from baseline up to 3 years

change from baseline, improvement

Secondary/protocol endpoint/low confidence

Mean change of lipid metabolism

Time frame:from baseline up to 3 years

change from baseline, improvement

Safety / tolerability / PK

1 endpoint

Primary/protocol endpoint

Adverse event incidence

Time frame:3 years

Treatment-emergent AEs (any)

event count, event

Provenance

Sources

Trial identity, design, statusClinicalTrials.gov API v2

Snapshot dateJuly 1, 2026

Endpoint classificationDelfa endpoint taxonomy v2 (May 13, 2026)

Results tableno registry results posted yet

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.