NN2211-4077 Retrospective collection of effectiveness and safety data from patients treated with liraglutide or DPP-4 inhibitor in primary care in Europe

Study type

• Study topic:
  Disease /health condition

  Human medicinal product
• Study type:
  Non-interventional study
• Scope of the study:
  Effectiveness study (incl. comparative)

  Safety study (incl. comparative)
• Data collection methods:
  Primary data collection

Non-interventional study

• Non-interventional study design:
  Cohort

Study drug and medical condition

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

  DIPEPTIDYL PEPTIDASE 4
• Medical condition to be studied:
  Type 2 diabetes mellitus

Population studied

• Short description of the study population:
  Consecutive patients with type 2 diabetes initiated on liraglutide or a DPP-4 inhibitor and primarily managed in primary care with 12 (-3/+6, e.g. 9 to 18) months of available data from UK, France, Germany and Spain.
• 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:
  Diabetes mellitus patients
• Estimated number of subjects:
  952

Study design details

• Main study objective:
  To demonstrate the clinical effectiveness, safety and place in clinical practice of liraglutide and DPP-4 inhibitor therapy in routine primary care across Europe.
• Outcomes:
  -Change in HbA1c (glycosylated haemoglobin), -Change in body weight-Change in systolic blood pressure
• Data analysis plan:
  A full statistical analysis plan will be developed. In brief, we will undertake the testing of treatment difference using a linear mixed effects model with extend the mulilevel modeling to include center and country effects. Analysis will be adjusted for baseline demographic and risk factors profiles concordant with the data collected as specified in the study protocol.

Documents

Study results

4077-ctr-redacted