Study type

Study topic

Human medicinal product

Study type

Non-interventional study

Scope of the study

Assessment of risk minimisation measure implementation or effectiveness

Data collection methods

Primary data collection
Non-interventional study

Non-interventional study design

Cohort
Study drug and medical condition

Name of medicine

TRULICITY

Study drug International non-proprietary name (INN) or common name

DULAGLUTIDE

Anatomical Therapeutic Chemical (ATC) code

(A10BJ05) dulaglutide
dulaglutide

Medical condition to be studied

Pancreatic carcinoma
Thyroid cancer
Population studied

Short description of the study population

Adult patients with confirmed diagnosis of T2DM who initiated a second-line antidiabetic medication (ADM) during the observation period and met the related inclusion and exclusion criteria within this study.

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)

Estimated number of subjects

325000
Study design details

Study design

Retrospective, non-interventional post-authorization safety study

Main study objective

To estimate the incidence rates and evaluate the potential association of pancreatic cancer and thyroid cancer (including subtypes: Papillary, Follicular, and Medullary C-cell tumor) for patients with T2DM who initiated dulaglutide compared to those who initiated other non-incretin second-line ADMs.

Setting

This study will be conducted using national health registries, including data collected in outpatient and inpatient settings from Sweden and Finland.

Comparators

Comparison 1: dulaglutide initiators compared to non-incretin second-line ADM initiators
Comparison 2: dulaglutide initiators compared to other GLP-1 RA initiators (excluding dulaglutide), and
Comparison 3: all GLP-1 RA initiators compared to non-incretin second-line ADM initiators.

Outcomes

Pancreatic cancer, thyroid cancer (including subtypes: Papillary, Follicular, and Medullary [C-cell tumour])

Data analysis plan

The primary analysis will be an intention to treat (ITT) approach, in which pancreatic cancer and thyroid cancer will be assessed any time after the end of an exposure latency period of 3-years.
Cox proportional hazards regression with matching on the exposure propensity score (EPS) to control for the potential confounders will be applied to compare exposure groups with respect to the outcomes of interest.