Clinical trial NCT01767389: Glucagon-like Peptide (GLP) Utilization and Safety
Official title: Glucagon-like Peptide-1 (GLP-1) Agonists: Treatment Utilization Patterns and Risk of Acute Pancreatitis
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Diabetes Mellitus, Type 2
Keywords: utilization
acute pancreatitis
Exenatide
DPP-4 inhibitors
liraglutide
GLP-1 receptor agonist
adherence
Lead sponsor: GlaxoSmithKline
Sponsor class: INDUSTRY
First posted: 2013-01-14
Enrollment: 1
Sex: ALL
Minimum age (years): 18
Maximum age (years): 64
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 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

Brief summary: This study will assess the utilization patterns (adherence, source of the index antidiabetic agent (ADA) and treatment modification) of the marketed glucagon-like peptide-1 (GLP-1) receptor agonists (exenatide and liraglutide), dipeptidyl-peptidase-4 (DPP-4) inhibitors (sitagliptin, saxagliptin, and linagliptin) and other ADAs and the incidence rate of acute pancreatitis among the users of these GLP-1 receptor agonists and users of DPP-4 inhibitors, separately, in comparison to other ADAs.

The proposed study will help in understanding the treatment utilization patterns and the incidence rate of acute pancreatitis among users of the marketed GLP-1 receptor agonists. This study differs from previous observational studies by including both exenatide and liraglutide and follow-up time is expected to be longer in the current study (2005 - 2011).

This study will be a retrospective cohort study conducted in the Truven (Thomson Reuters) commercial health insurance database from 2005-2011.


Eligibility criteria: 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.

Primary outcomes:
measure: For treatment utilization patterns: adherence will be assessed.
timeFrame: 6 years
measure: For treatment utilization patterns: source of the index ADA (add-on, switch or new therapy) will be assessed.
timeFrame: 6 years
measure: 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.
timeFrame: 6 years
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: GlaxoSmithKline
name: GSK Clinical Trials
role: STUDY_DIRECTOR
References: