Real world glycemic effectiveness of linagliptin (Tradjenta®) among type 2 diabetes mellitus adults by age and renal function.

Study type

• Study topic:
  Human medicinal product
• Study type:
  Non-interventional study
• Scope of the study:
  Effectiveness study (incl. comparative)
• Data collection methods:
  Secondary use of data

Non-interventional study

• Non-interventional study design:
  Other
• Non-interventional study design, other:
  Retrospective database study

Study drug and medical condition

• Medicinal product name, other:
  Tradjenta
• Study drug International non-proprietary name (INN) or common name:
  LINAGLIPTIN
• Anatomical Therapeutic Chemical (ATC) code:
  (A10BH05) linagliptin

  linagliptin
• Medical condition to be studied:
  Type 2 diabetes mellitus

Population studied

• Short description of the study population:
  Patients with T2DM newly initiated on linagliptin, in the Optum electronic ; health record (EHR) database, aged 40 and older, and with HbA1c values ; during the both the 180 days before and the 60 to 180 days after starting ; linagliptin
• 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:
  Renal impaired
• Estimated number of subjects:
  13962

Study design details

• Study design:
  This will be a non-interventional cohort study using existing data from patients in the Optum ; Clinical Database which contains electronic health record (EHR) data from providers across ; the United States.
• Main study objective:
  •Describe change in HbA1c among adults with T2DM w/in 60 to 180 days following initiation of linagliptin across pre-defined age and renal function categories.
• Outcomes:
  change in (Glycosylatedhemoglobin)HbA1c, will beevaluated among the overallstudy sample and stratifiedacross pre-defined age andrenal function categories, Glycosylated hemoglobin(HbA1c) goal attainment, asdefined below, will beevaluated among the overallstudy sample and stratifiedacross pre-defined age andrenal function categories
• Data analysis plan:
  Sample will be selected from national EMR database to produce generalizable estimates. The study will employ methods (e.g regression) to account for known confounding.