Study type

Study type

Non-interventional study

Scope of the study

Assessment of risk minimisation measure implementation or effectiveness
Non-interventional study

Non-interventional study design

Cohort
Study drug and medical condition

Anatomical Therapeutic Chemical (ATC) code

(A10A) INSULINS AND ANALOGUES

Medical condition to be studied

Prostate cancer
Breast cancer
Colorectal cancer
Non-small cell lung cancer
Bladder cancer
Skin cancer
Cervix carcinoma
Non-Hodgkin's lymphoma
Pancreatic carcinoma
Hepatobiliary cancer
Population studied

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)

Estimated number of subjects

5000000
Study design details

Main study objective

The primary aim of the study is to quantify the risk of cancer associated with the (long-term) use of insulin and insulin analogues by studying the effects of dosage, duration and/or intensity of insulin treatment on the likelihood of developing cancer and different types of cancer.

Outcomes

- prostate cancer - breast cancer - colorectal cancer - lung cancer - bladder cancer - melanoma of skin - cancer of corpus uteri - non-Hodgkin lymphoma - pancreatic cancer - liver cancer, Any cancer, excluding non-melanoma skin cancer.

Data analysis plan

We will perform a series of population-based cohort studies, using the Norwegian, Swedish, Danish and Finnish National Health Registries and the Clinical Practice Research Datalink (CPRD) from the United Kingdom. Studies will be performed in all databases separately, and multi-country data will be combined using several approaches.
Documents
Study results
English (1.53 MB - PDF)View document