Evaluating the cost and clinical outcomes of changing type 2 diabetes mellitus patients from current DPP-4 inhibitor treatment to alogliptin in a primary care setting

Study type

• Study topic:
  Disease /health condition

  Human medicinal product
• 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

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

Study drug and medical condition

• Study drug International non-proprietary name (INN) or common name:
  ALOGLIPTIN
• Medical condition to be studied:
  Type 2 diabetes mellitus

Population studied

• Short description of the study population:
  The study population include all T2DM patients who have had therapy changed from another DPP-4 inhibitor to alogliptin, in combination with other hypoglycaemic agent(s) in primary care.
• 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:
  Type 2 diabetes mellitus patients
• Estimated number of subjects:
  1000

Study design details

• Main study objective:
  The primary objective of the study is to retrospectively estimate the clinical impact of changing T2DM patients from current DPP-4 inhibitor to alogliptin, assessed by the unadjusted and adjusted change in HbA1c between pre and post switch measurements and including deviation from HbA1c trajectory.
• Outcomes:
  To capture the primary outcome, HbA1c measurements (% HbA1c numeric value and date recorded DD/MM/YYY) will be collected for the pre and post-index periods. The index date will also be recorded for each patient. The secondary outcome will assess impact on direct prescribing costs resulting from changing T2DM patients from current DPP4 inhibitor to alogliptin within licenced indications, dose and frequency of alogliptin, Alogliptin stop date post index, Start date of anti-diabetic therapy rescue medication, Anti-diabetic medication and dose added on rescue, Changes to existing anti-diabetic medication.
• Data analysis plan:
  Continuous variables will be described by their mean, standard deviation, median, quartiles 1 and 3, extreme values (minimum and maximum), 95% confidence intervals and frequency of missing data. Categorical variables will be described by their frequency and percentage of the sample population. A generalised linear mixed effects model will be used to assess for any change in HbA1c trajectory as a function of switching to alogliptin. Fisher’s exact tests will be used for binary categorical variables and Chi-squared tests will be used for (unordered) categorical variables. A p-value of less than 0.05 will be considered statistically significant.