Dulaglutide Modified-Prescription-Event Monitoring Study and network database study: a multi-database collaborative research program of observational studies to monitor the utilisation and safety of dulaglutide in the EU

Study type

• Study topic:
  Disease /health condition

  Human medicinal product
• Study type:
  Non-interventional study
• Scope of the study:
  Drug utilisation

  Safety study (incl. comparative)
• Data collection methods:
  Combined primary data collection and secondary use of data

Non-interventional study

• Non-interventional study design:
  Cohort

  Other
• Non-interventional study design, other:
  Prescription event monitoring

Study drug and medical condition

• Name of medicine:
  TRULICITY
• Medical condition to be studied:
  Pancreatitis

  Hypersensitivity

  Thyroid cancer

  Pancreatic carcinoma

  Arrhythmia supraventricular

  Conduction disorder

  Gastrointestinal disorder

  Medication error

Population studied

• Short description of the study population:
  The study population will consist of new user patients with T2DM who were prescribed dulaglutide in the EU.
• Age groups:
  Children (2 to < 12 years)

  Adolescents (12 to < 18 years)

  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:
  Hepatic impaired

  Other

  Pregnant women

  Renal impaired
• Special population of interest, other:
  Patients with Pancreatitis, Hypersensitivity, Thyroid cancer, Pancreatic carcinoma, Arrhythmia supraventricular, Conduction disorder, Gastrointestinal disorder, Medication error
• Estimated number of subjects:
  10000

Study design details

• Main study objective:
  The overall aim of this multi-database PASS program is to assess and understand the utilisation and safety profile of dulaglutide in patients with Type II diabetes mellitus.
• Outcomes:
  To estimate the cumulative incidence in the first 12 months of treatment with dulaglutide of the following events of interest: (a) Acute pancreatitis (b) Hypersensitivity (c) Cardiovascular (CV) events and conduction abnormalities (d) Gastrointestinal (GI) effects (e) Medication errors, For patients receiving dulaglutide: 1. To describe the baseline profile of patients 2. To explore time to onset of primary outcomes of interest and to explore predictors of risk 3. To describe the safety profile in sub-populations missing from the EU Risk Management Plan 4. To estimate the period prevalence of pancreatic and/or thyroid cancer
• Data analysis plan:
  To estimate the cumulative incidence of primary events of interest in the first 12 months after starting treatment: Crude annualised cumulative incidence (percent of total valid cohort exposed) and cumulative rate (according to 1000 patients exposed), with 95% binomial and poisson exact Confidence Intervals (CI) for events of interest will be calculated, respectively. Graphs of cumulative counts of events of interest, by month over the study period, will be examined for possible change in reporting over calendar time. Points that will be taken into account in the analysis are the baseline characteristics, possible confounding factors and background incidence of the selected events in the study population during the observation period regardless of duration of exposure to dulaglutide. The incidence rate of these events will also be explored by estimating hazard over time.

Documents

Study results

Dulaglutide MPEM and network study final report abstract for EUPAS Register