A description of oral and non-insulin injected hypoglycemic therapy utilization patterns including initiation, switching, and discontinuation (Non-insulin hypoglycemic therapy utilization)

Study type

• Study topic:
  Human medicinal product

  Disease /health condition
• Study type:
  Non-interventional study
• Scope of the study:
  Drug utilisation
• Data collection methods:
  Secondary use of data

Non-interventional study

• Non-interventional study design:
  Cohort

Study drug and medical condition

• Anatomical Therapeutic Chemical (ATC) code:
  (A10B) BLOOD GLUCOSE LOWERING DRUGS, EXCL. INSULINS

  BLOOD GLUCOSE LOWERING DRUGS, EXCL. INSULINS
• Medical condition to be studied:
  Diabetes mellitus

Population studied

• Short description of the study population:
  Patients with Diabetes mellitus aged 18 years and over
• 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:
  200000

Study design details

• Main study objective:
  To understand (1)existing utilization patterns for linagliptin, other dipeptidyl peptidase-4 (DPP-4) inhibitors, other oral and non-insulin injected hypoglycemic agents, and (2) differences in utilization patterns between these agents to help with the design, analysis and interpretation of comparative effectiveness and safety studies of linagliptin, other DPP-4 inhibitors, and other agents.
• Outcomes:
  Primary outcomes are:- Proportion of initiators - Treatment switching- Treatment augmentation- Subsequent Insulin initiation, Secondary outcomes are:- Persistence at 12 months - Persistence at 3 months- Persistence at 6 months- Proportion of days covered- Treatment discontinuation
• Data analysis plan:
  Analyses are descriptive. Utilization patterns will be examined overall and in subgroups defined by patient characteristics, incident/former use, and over time. Adherence analyses will be conducted in propensity-score matched cohorts. The analyses will be based on May 2011 - June 2012 data.