Glucagon-like Peptide (GLP) Utilization and Safety

Condition(s) targeted: Diabetes Mellitus, Type 2

Intervention: The GLP-1 receptor agonist users (Other); DPP-4 inhibitor users (Other); Other ADA users (Other)

Phase: N/A

Status: Completed

Sponsored by: GlaxoSmithKline

Official(s) and/or principal investigator(s):
GSK Clinical Trials, Study Director, Affiliation: GlaxoSmithKline

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.

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

Study design: Observational Model: Cohort, Time Perspective: Retrospective

Primary outcome:

For treatment utilization patterns: adherence will be assessed.

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

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.

Minimum age: 18 Years. Maximum age: 64 Years. Gender(s): Both.

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.

Starting date: September 2012
Last updated: July 31, 2014