DelfaGLP-1 Atlas

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Completed

Comparison of the Effectiveness and Tolerability of Exenatide Once-weekly Compared to Basal Insulins

A Cohort Study of the Benefits of Bydureon in Customary Clinical Care in the United States

Lead sponsor

AstraZeneca

Asset

Exenatide

GLP-1 agonist

Listed sites

1

Recruiting sites

—

Enrollment

7,000

actual

Study population

Type 2 diabetes

Key I/E criterion

—

Primary endpoints

•HbA1c, change•Body weight, absolute change (kg)

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 IDNCT02974244
Org study IDD5551R00008

Timeline

Milestones

Study start2014-10-28actual
Primary completion2014-10-28actual
Study completion2014-10-28actual
Study first posted2016-11-28estimated
Last update posted2017-03-29actual

Assets

Investigational agents

Exenatide

Study populations

Who this study enrolls

Type 2 diabetes

Eligibility

Who can enroll

Minimum age18 Years
Maximum age89 Years
SexAll
Healthy volunteersNot accepted
Sampling methodNon probability sample

Study population text

This cohort study compares injectable-naive exenatide once-weekly and basal insulin initiators. The study cohorts were drawn from an Optum's Electronic Health Records database that integrates records from many medical groups and hospitals in the United States representing over 25,000 physicians and over 25 million patients in ordinary clinical practice. The Electronic Health Records captures clinical, operational, and financial information that physicians record at the time of care. This information includes diagnoses, procedures, medications (prescribed and administered), clinical measures (biometric and laboratory values), and clinical notes (e.g., physician, pathology, and radiology notes).

Inclusion criteria

•At least 18 years old;
•had received care documented in Electronic Health Records (including at least one out-patient provider visit) for a minimum of 6-months prior index date;
•had at least one diagnosis of type 2 diabetes by The International Classification of Diseases, Ninth Revision, Clinical Modification (ICD-9-CM: 250.X0 or 250.X2) prior to and including the date of the study drug initiation, with no prior diagnosis of type1 diabetes (ICD-9-CM: 250.X1 or 250.X3), or gestational diabetes within the 6-months prior to index date;
•No evidence of prior injectable antidiabetic treatment, specifically no dispensing of a GLP-1RA or any insulin during the 6-months baseline period prior to study drug initiation

Exclusion criteria

•Prior diagnosis of type1 diabetes (ICD-9-CM: 250.X1 or 250.X3), or gestational diabetes within the 6-months prior to index date;
•Prior dispensing of a GLP-1RA or any insulin

Endpoints (6)

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

Safety / tolerability / PK
4
Weight & body composition
1
Glycemic / diabetes
1

Weight & body composition

1 endpoint
Primary/protocol endpoint

Changes from baseline in weight (kg)

Time frame:one year post-index

Body weight, absolute change (kg)

change from baseline, improvement

Glycemic / diabetes

1 endpoint
Primary/protocol endpoint

Changes from baseline in HbA1c (%)

Time frame:one year post-index

HbA1c, change

change from baseline, improvement

LOINC 4548-4

Safety / tolerability / PK

4 endpoints
Secondary/protocol endpoint

Frequency of hypoglycemia

Time frame:one year post-index

event count, event

Secondary/protocol endpoint

Frequency of nausea

Time frame:One year post-index

Nausea

event count, event

Secondary/protocol endpoint

Frequency of vomiting

Time frame:one year post-index

Vomiting

event count, event

Secondary/protocol endpoint

Frequency of diarrhea and constipation

Time frame:One year post-index

event count, event

componentsDiarrhea

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.