Diabetes, Insulin and Malignancies Study New User Protocol (DIMSum)

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

Study drug and medical condition

• Anatomical Therapeutic Chemical (ATC) code:
  (A10AC01) insulin (human)

  insulin (human)

  (A10AE04) insulin glargine

  insulin glargine
• Medical condition to be studied:
  Diabetes mellitus

Population studied

• Short description of the study population:
  Patients with diabetes aged 18 years and older at the time of first use of insulin (glargine or NPH).; For the analysis of data from Partners HealthCare System and Ochsner, individuals from their diabetes registries will be eligible to enter the new user cohort on January 1, 2005 (approximately) or later at the time of their first eligible prescription of either insulin glargine or NPH insulin. The earliest date when individuals in the MedAssurant database will enter the new user cohort is July 1, 2004. Individuals must have at least 19 months of continuous membership and pharmacy benefits prior to new user cohort entry; if membership is not well defined, a prescription is required in each of four 6-month periods prior to the first eligible prescription.
• Age groups:
  • Adult and elderly population (≥18 years)

    • Adults (18 to < 65 years)

      • Adults (18 to < 46 years)
      • Adults (46 to < 65 years)
    • Elderly (≥ 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:
  61000

Study design details

• Main study objective:
  The primary objective of the study is to investigate whether use of the long-acting insulin glargine is associated with an increased cancer risk compared with use of human NPH insulin.
• Outcomes:
  The three primary outcomes include breast, prostate and colon cancer individually. The secondary outcome will be all cancers combined excluding non-melanoma skin cancers.
• Data analysis plan:
  New users of glargine insulin will be compared with new users of NPH insulin with respect to cancer outcomes. We will use propensity scores to balance measured risk factors for cancer between these cohorts. To address the potential for confounding by BMI not measured in the claims database, we will assess the independent contribution of BMI towards the propensity score in 2 external validation studies using electronic medical records data. Hazard rates for each of the cancer endpoints will be estimated using a Cox proportional hazards model controlling for age and sex as well as any covariates remaining imbalanced after implementation of the propensity score. See full protocol for additional details and description of secondary and sensitivity analyses.