Incidence of Pancreatic Malignancy and Thyroid Neoplasm in Type 2 Diabetes Mellitus Patients who Initiate Exenatide Compared to Other Antihyperglycemic Drugs - Phase 2 (Extended Accrual and Follow-Up)

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:
  Case-control

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

Study drug and medical condition

• Name of medicine:
  BYDUREON

  BYETTA
• Study drug International non-proprietary name (INN) or common name:
  EXENATIDE
• Medical condition to be studied:
  Type 2 diabetes mellitus

Population studied

• Short description of the study population:
  Patients with Type 2 Diabetes Mellitus who had at least 9 months of continuous enrollment in their health plan between 01 September 2004 and 31 December 2015. ; Eligible patients will have:; • Complete medical and pharmacy benefits and at least 9 months of continuous enrollment in the health plan prior to the cohort entry date; • A diagnosis of T2D (ICD-9-CM 250.x0, 250.x2) during the 9-month baseline period, inclusive of the cohort entry date; • A dispensing of at least one antidiabetic drug other than the initiating drug during the 9- month baseline period, inclusive of the cohort entry date
• Age groups:
  Children (2 to < 12 years)

  Adolescents (12 to < 18 years)

  Adults (18 to < 46 years)

  Adults (46 to < 65 years)

  Adults (65 to < 75 years)

  Adults (75 to < 85 years)

  Adults (85 years and over)
• Special population of interest:
  Other
• Special population of interest, other:
  Diabetes mellitus patients
• Estimated number of subjects:
  523741

Study design details

• Main study objective:
  The primary objectives are to estimate the absolute and relative incidence of pancreatic cancer and thyroid cancer that occurs at least one year after initiation of exenatide twice daily or once weekly or initiation of other antidiabetic drugs—overall and by duration of follow-up and duration of exposure.
• Outcomes:
  The primary outcomes are newly diagnosed pancreatic cancer and thyroid cancer occurring at least one year following cohort entry. The secondary outcomes are newly diagnosed benign thyroid neoplasm, medullary thyroid carcinoma, and non-medullary thyroid carcinoma occurring at least one year following cohort entry.
• Data analysis plan:
  An “intent-to-treat” analysis will be conducted that holds the original exposure assignment constant from the date of accrual through the end of follow-up. At-risk person-time will be accrued from one year post drug initiation until the earliest occurrence of an outcome, health plan disenrollment, or end of study period. Hazard ratios and 95% confidence intervals of newly diagnosed pancreatic cancer or thyroid cancer will be estimated. To estimate the cumulative effect of exenatide exposure on the outcomes Analysis of Cumulative Exposure will also be conducted. A nested case-control study design will be applied to account for potential confounders that are poorly captured in the claims data. The cases will consist of all chart-confirmed cases of pancreatic or thyroid cancers in the propensity-matched exenatide and comparison cohorts from the Optum Research Database. Controls without cancers will be selected from the same source cohorts that gave rise to the cases.

Documents

Study results

D5550R00003 (EUPAS13956) Revised Final Report 17APR2018_AZ_Redacted