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Completed

Glucagon-like Peptide (GLP) Utilization and Safety

Glucagon-like Peptide-1 (GLP-1) Agonists: Treatment Utilization Patterns and Risk of Acute Pancreatitis

Lead sponsor

GlaxoSmithKline

Assets

Exenatide / GLP-1 / incretin class catch-all / Liraglutide

Listed sites

0

Recruiting sites

Enrollment

1

actual

Study population

Type 2 diabetes

Key I/E criterion

Primary endpoint

For treatment utilization patterns

Identifiers

Registered as

NCT IDNCT01767389
Org study ID200065
Secondary IDWEUSKOP6477GSK

Timeline

Milestones

Study first posted2013-01-14estimated
Last update posted2014-08-04estimated
Study start2012-09 (month precision)
Primary completion2013-12actual (month precision)
Study completion2013-12actual (month precision)

Assets

Investigational agents

Study populations

Who this study enrolls

Type 2 diabetes

Eligibility

Who can enroll

Minimum age18 Years
Maximum age64 Years
SexAll
Healthy volunteersNot accepted
Sampling methodNon probability sample

Study population text

The study population will include subjects aged ≥ 18 and ≤ 64 years as of index date and those who have continuous enrolment for at least 12 months in Truven (Thomson Reuters) commercial health insurance database from 2005-2011. The Truven database captures person-specific clinical utilization, expenditures, and enrolment across inpatient, outpatient, prescription drug, and carve-out services from a selection of large employers, health plans, and government and public organizations. This databases links paid claims and encounter data to detailed patient information across sites and types of providers, and over time. The annual medical databases include private sector health data from approximately 100 payers. Historically, more than 500 million claim records are available in the database. The Commercial Claims and Encounters Database represents the medical experience of insured employees and their dependents for active employees, early retirees, COBRA continues, and their dependents i

Inclusion criteria

Subjects aged ≥ 18 and ≤ 64 years as of index date and those who have continuous enrolment for at least 12 months in Truven
Subjects should have complete medical and pharmacy benefits and continuous enrolment in the health plan for at least 12 months before the index date (pre-index period).
Subjects should also have at least 1 claim of T2D diagnosis identified using ICD-9 codes 250.x0 or 250.x2 (excluding 250.x1 and/or 250.x3 - Type 1 diabetes and 648.0x - gestational diabetes)

Exclusion criteria

For the objective of evaluating the association between GLP-1 receptor agonists, DPP-4 inhibitors and acute pancreatitis as compared to the association observed between this outcome and the use of other ADAs, subjects having evidence of pancreatic disease (ICD 9 code of 577.xx) in the pre-index period (12 months before the index date) will be excluded.

Endpoints (3)

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 (unclassified)
2
Other clinical outcomes
1

Other clinical outcomes

1 endpoint
Primary/protocol endpoint/low confidence

For treatment utilization patterns: source of the index ADA (add-on, switch or new therapy) will be assessed.

Time frame:6 years

descriptive

Other (unclassified)

2 endpoints
Primary/protocol endpoint/low confidence

For treatment utilization patterns: adherence will be assessed.

Time frame:6 years

descriptive

Primary/protocol endpoint/low confidence

For treatment utilization patterns: treatment modification (discontinuation of the index ADA, switching of the index and concomitant ADA, and add-on therapy) will be assessed.

Time frame:6 years

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.