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

Study type

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

Non-interventional study

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

Study drug and medical condition

• Medical condition to be studied:
  Type 2 diabetes mellitus

Population studied

• Age groups:
  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

• 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.