An Observational Study of the Risk of Acute Pancreatitis in Subjects Exposed to Albiglutide, Other GLP-1 Agonists or DPP-4 Inhibitors Compared to Other Antidiabetic Agents (201804)

Study type

• Study topic:
  Disease /health condition

  Human medicinal product
• Study type:
  Non-interventional study
• Scope of the study:
  Assessment of risk minimisation measure implementation or effectiveness
• Data collection methods:
  Secondary use of data

Non-interventional study

• Non-interventional study design:
  Cohort

  Other
• Non-interventional study design, other:
  Retrospective study

Study drug and medical condition

• Name of medicine:
  EPERZAN
• Name of medicine, other:
  Tanzeum
• Study drug International non-proprietary name (INN) or common name:
  ALBIGLUTIDE
• Anatomical Therapeutic Chemical (ATC) code:
  (A10) DRUGS USED IN DIABETES

  DRUGS USED IN DIABETES
• Medical condition to be studied:
  Type 2 diabetes mellitus

Population studied

• Short description of the study population:
  The study used the Truven Marketscan Commercial database to analyze the use of albiglutide in treating type 2 diabetes (T2D). The study population included individuals aged 18-64 years, enrolled in a health plan for at least 6 months, with at least one type 2 diabetes (T2D) diagnosis claim and two consecutive prescription claims for a new antidiabetic agents (ADA) from April 15, 2014, to September 30, 2016. ; Inclusion criteria:; 1. Patients with at least one claim of T2D diagnosis in database; 2. Patients with gestational diabetes; 3. Patients with at least one antidiabetic medication starting from April 15, 2014; 4. Limit age 18-64 years old; 5. Patients who continuously enrolled and have pharmacy coverage in the health plan for ≥6 months prior index date; 6. Patients who have at least two consecutive prescription claims; 7. Patients who are a new user (based on group level); ; Exclusion criteria:; 1. Exclude the patients who have evidence of pancreatitis disease in the pre-index period
• Age groups:
  Adults (18 to < 46 years)

  Adults (46 to < 65 years)
• Special population of interest:
  Other
• Special population of interest, other:
  Patients with type 2 diabetes mellitus
• Estimated number of subjects:
  5000

Study design details

• Main study objective:
  1. Compare the association between albiglutide and acute pancreatitis to other antidiabetic agents (ADAs) (excluding GLP-1 agonists and DPP-4 inhibitors).2. Evaluate the association between GLP-1 agonists (including and excluding albiglutide), DPP-4 inhibitors and acute pancreatitis as compared to the association observed between this outcome and use of other ADAs.
• Outcomes:
  Acute pancreatitis identified in the post-index follow up period by hospitalization claims containing ICD-9 code 577.0 (acute pancreatitis) as a primary discharge diagnosis. Time to acute pancreatitis
• Data analysis plan:
  Unadjusted incidence rates (along with 95% confidence interval) of acute pancreatitis will be calculated for the each exposure group. Differences in exposure groups of time to acute pancreatitis will be assessed using Kaplan Meier survival curves with log rank test. Cox Proportional Hazards modeling will be used to compare the adjusted risk of acute pancreatitis among subjects treated with albiglutide, GLP-1 agonists excluding albiglutide, GLP-1 agonists including albiglutide, and DPP-4 inhibitors compared to other ADAs (reference group). A separate Cox Proportional Hazards model will be run for which the censoring criterion of discontinuation of the index medication is not applied. This model represents an “ever exposed” analysis compared to the “on treatment” analysis above. Secondary analyses will be conducted to determine if there is a relationship between the duration of exposure to albiglutide and acute pancreatitis, using number of prescriptions and cumulative duration of use.