An Observational Study of the Risk of Malignant Neoplasms and Malignant Neoplasms of Special Interest (Thyroid and Pancreatic Cancer) in Subjects Treated with Albiglutide Compared to Those Treated with Other Antidiabetic Agents (201805)

Study type

• Study topic:
  Human medicinal product

  Disease /health condition
• 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

Study drug and medical condition

• Name of medicine:
  EPERZAN
• 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 diabetes cohort will include type 2 diabetes subjects aged ≥ 18 years old at cohort entry and who had at least three consecutive new prescription for the same antidiabetic agent in the Clinical Practice Research Datalink (CPRD) when albiglutide will be fully launced in the U.K.
• Age groups:
  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:
  Type 2 diabetes mellitus patients
• Estimated number of subjects:
  10000

Study design details

• Main study objective:
  1.Compare the risk of malignant neoplasms (MN) of special interest (thyroid and pancreatic) in subjects prescribed albiglutide to other antidiabetic agents2.Compare the risk of MN of special interest in subjects prescribed albiglutide with insulin, to insulin3.Compare the risk of most common MN (breast, prostate, colorectal and lung) in subjects prescribed albiglutide with insulin, to insulin.
• Outcomes:
  Malignant neoplasms of special interest (thyroid and pancreatic cancer). Other common malignant neoplasms (breast, prostate, colorectal, and lung cancers).
• Data analysis plan:
  Conditional logistic regression will be used to estimate odds ratios along with 95% confidence intervals (CIs) of the malignant neoplasms of special interest and the common malignant neoplasms associated with the use of albiglutide compared to other antidiabetic agents. Separate conditional logistic regression models will be run for the various objectives of the study, providing likelihood ratios for the cancers of special interest as well as the most common malignant neoplasms. For the cancers of special interest, subjects ever exposed to albiglutide will be compared to subjects exposed to other antidiabetic agents. For the common malignant neoplasms, subjects ever exposed to albiglutide in combination with insulin will be compared to those exposed to insulin.