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Completed

Economic Outcomes of EQW (Exenatide Once Weekly) vs. IG (Insulin Glargine) in T2D Patients Who Are New to Injectable Therapy

Clinical and Economic Outcomes of Patients With Type 2 Diabetes Mellitus Initiating Bydureon and Glargine

Lead sponsor

AstraZeneca

Asset

Exenatide

GLP-1 agonist

Listed sites

1

Recruiting sites

Enrollment

15,498

actual

Study population

Type 2 diabetes

Key I/E criterion

Primary endpoint

Diabetes-related HCRU/costs

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 IDNCT02843399
Org study IDD5551R00012

Timeline

Milestones

Study first posted2016-07-25estimated
Study start2016-08-15actual
Primary completion2016-12-15actual
Study completion2016-12-15actual
Last update posted2017-12-15actual

Assets

Investigational agents

Study populations

Who this study enrolls

Type 2 diabetes

Eligibility

Who can enroll

Minimum age18 Years
Maximum age99 Years
SexAll
Healthy volunteersNot accepted
Sampling methodNon probability sample

Study population text

Commercial Insurance

Inclusion criteria

1. One or more outpatient prescription claim for EQW (Exenatide Once Weekly) vs. IG (Insulin Glargine) between February 1, 2012, and June 30, 2014 (date of first claim = index date; medication to which first claim corresponds = index therapy).

2. Aged 18 or older as of the index date.

3. Continuous enrollment in medical and pharmacy benefits for 12 months before (baseline period) and 12 months after (follow-up period) the index date. (6 months follow-up will be provided to determine the effect on sample size.)

4. One or more medical claims with a diagnosis code for T2DM (ICD-9-CM 250.x0 or 250.x2) in the baseline period or on the index date.

Exclusion criteria

1. No outpatient prescription claims for any injectable glucose-lowering medication during the baseline period (GLP-1RA or insulins).

2. No medical claims with a diagnosis (or procedure, where appropriate) code indicative for type 1 diabetes mellitus (ICD-9-CM 250.x1 or 250.x3), gestational diabetes (ICD-9-CM 648.8x), or pregnancy or childbirth in the baseline or follow-up periods.

Endpoints (5)

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

Other clinical outcomes
2
Glycemic / diabetes
1
Safety / tolerability / PK
1
Other (unclassified)
1

Glycemic / diabetes

1 endpoint
Other/protocol endpoint

Composite of A1C <7%/no weight gain/no hypoglycemia

Time frame:Up to 12 Months

threshold achievement, improvement

componentsHbA1c <7.0% achievement, Body weight, absolute change (kg), Documented hypoglycemia

Safety / tolerability / PK

1 endpoint
Secondary/protocol endpoint

Medical Hypoglycemic events

Time frame:Up to 12 Months

event count, event

Other clinical outcomes

2 endpoints
Primary/protocol endpoint/low confidence

Diabetes-related HCRU/costs

Time frame:Up to 12 months

descriptive

Secondary/protocol endpoint/low confidence

Overall HCRU/Costs

Time frame:Up to 12 Months

descriptive

Other (unclassified)

1 endpoint
Secondary/protocol endpoint/low confidence

MACE-related HCRU/Costs

Time frame:Up to 12 Months

descriptive

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.