DelfaGLP-1 Atlas

← Trials/Trial dossier/NCT02917057

Completed

Subanalyses of Elderly Type 2 Diabetes Patients or Type 2 Diabetes Patients With Renal Impairment

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

Lead sponsor

AstraZeneca

Asset

Exenatide

GLP-1 agonist

Listed sites

1

Recruiting sites

—

Enrollment

6,024

actual

Study population

Renal impairment, 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 IDNCT02917057
Org study IDD5551R00011

Timeline

Milestones

Study start2015-08-01actual
Primary completion2015-08-01actual
Study completion2015-08-01actual
Study first posted2016-09-28estimated
Last update posted2018-03-29actual

Assets

Investigational agents

Exenatide

Study populations

Who this study enrolls

Renal impairmentType 2 diabetes

Eligibility

Who can enroll

SexAll
Healthy volunteersNot accepted
Sampling methodNon probability sample

Study population text

The study population was drawn from an Optum's Electronic Health Records (EHR) database. Injectable-naive type 2 diabetic patients who initiated therapy with either Exenatide once-weekly or basal insulin from January 2012 to January 2015, with follow-up through March 2015 were identified. The baseline period was defined as the 183 days (6-months) prior to date of study drug initiation (index date). Patients with Type 2 diabetes were identified using structured diagnosis fields and International Classification of Disease, Ninth Revision, Clinical Modification (ICD-9-CM) codes. Initiations of Exenatide once-weekly or basal insulin were identified in the EHR data capturing prescribed medications using National Drug Codes (NDC).

Inclusion criteria

•At least 18 years old;
•had received care documented in EHR (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 (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-1-RA or any insulin during the 6-months baseline period prior to study drug initiation

Exclusion criteria

•Prior diagnosis of type 1 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
•Missing data on renal function defined by eGFR or age

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
3
Weight & body composition
1
Glycemic / diabetes
1
Renal / kidney
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

Renal / kidney

1 endpoint
Secondary/protocol endpoint

Changes from baseline in eGFR

Time frame:one year post-index

eGFR, change

change from baseline, improvement

LOINC 98979-8

Safety / tolerability / PK

3 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

Publications (1)

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

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.