Cancer risk estimation study program in patients treated with insulin in France (GROC)

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:
  (A10A) INSULINS AND ANALOGUES

  INSULINS AND ANALOGUES
• Medical condition to be studied:
  Insulin-requiring type 2 diabetes mellitus

Population studied

• Short description of the study population:
  The study population was selected from the data available in the EGB on October 1, 2010.; The study population allowing the analysis of exposure to insulins is composed of of all EGB patients who have made at least one reimbursement request insulin between January 1, 2003 and December 31, 2009 to the National Health Insurance Fund for Salaried Workers (CNAM-TS) in Metropolitan France.; The patients included in the analysis are the patients in the study population:; – aged 18 and over;; – without ALD cancer before the first delivery of insulin;; – with at least 2 insulin deliveries during follow-up until June 30 2010;; – whose 1st issue did not take place in the same month as the death;; – without an isolated health care consumption “hole” during their exposure to insulin (patients leaving then re-entering the EGB because having changed regime, migrant, etc., i.e. at least one year without any reimbursement of care.
• 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:
  5000

Study design details

• Main study objective:
  study the posssible relationship between exposure to insulin glargine and the diagnosis of cancer
• Outcomes:
  registration for a diagnosis of cancer in diabetic patients using insulin, relationship with duration and intensity of exposure (medication possession rates) to insulin, sulfonylureas and metformin.incidence rates for individual cancer types.
• Data analysis plan:
  Cox time-dependent risk ratio and survival analysis of cancer adjusted for propensity score for exposure to human insulin vs glargine, in various user cohorts: incident exclusive users, all exclusive users, incident predominant users, all predominant users.

Documents

Study results

LANTUS-Cohortes-Synthèse résultats-01032011

Study publications

Blin P, Lassalle R, Dureau-Pournin C, Ambrosino B, Bernard MA, Abouelfath A, Gi…