Glucagon-like Peptide (GLP) Utilization and Safety
Condition: Diabetes Mellitus, Type 2
MeSH terms: Diabetes Mellitus, Type 2
Study type: Observational

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.
    


Intervention name(s): The GLP-1 receptor agonist users; DPP-4 inhibitor users; Other ADA users
Intervention type(s): Other; Other; Other
Intervention description(s): The GLP-1 receptor agonist users are classified based on the receipt of a GLP-1 receptor agonist at the index date. GLP-1 receptor agonists included in this study are exenatide and liraglutide; DPP-4 inhibitor users are classified based on the receipt of a DPP-4 inhibitor prescription at the index date. The DPP-4 inhibitors included in this study are sitagliptin, saxagliptin, linagliptin, combination of sitagliptin and metformin (Janumet), and combination of sitagliptin and simvastatin (Juvisync); Classes of ADA's other than GLP-1 receptor agonists and DPP-4 inhibitors will be included in the 'other ADA' exposure group
Intervention MeSH terms: Dipeptidyl-Peptidase IV Inhibitors
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
      
Keywords: utilization; acute pancreatitis; Exenatide; DPP-4 inhibitors; liraglutide; GLP-1 receptor agonist; adherence