Study about the results of the addition of a sulfonylurea, DPP4 inhibitors or SGLT2 inhibitors as a second antidiabetic drug in patients with diabetes mellitus type 2 in treatment with metformin and insufficient glycemic control. (eControl Met +)

Study type

• Study type:
  Non-interventional study
• Scope of the study:
  Assessment of risk minimisation measure implementation or effectiveness

  Drug utilisation

  Effectiveness study (incl. comparative)

Non-interventional study

• Non-interventional study design:
  Cohort

Study drug and medical condition

• Anatomical Therapeutic Chemical (ATC) code:
  (A10BA02) metformin

  metformin

  (A10BB) Sulfonylureas

  Sulfonylureas

  (A10BH) Dipeptidyl peptidase 4 (DPP-4) inhibitors

  Dipeptidyl peptidase 4 (DPP-4) inhibitors

  (A10BK) Sodium-glucose co-transporter 2 (SGLT2) inhibitors

  Sodium-glucose co-transporter 2 (SGLT2) inhibitors
• Medical condition to be studied:
  Diabetes mellitus management

Population studied

• 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)
• Estimated number of subjects:
  189776

Study design details

• Main study objective:
  The primary objective:• To compare the proportion of patients achieving the reduction in HbA1c values of at least 0.5%, a weight reduction of at least 3%, after the addition of a SU, an DPP-4i or an SGLT-2i to the treatment with metformin in patients with T2DM and insufficient glycemic control in the medium-long term, up to a maximum of 24 months of follow-up.
• Outcomes:
  As outcomes, we define the reduction of HbA1c of at least 0.5%, reduction of a weight of at least 3%, as well as occurrence of different side effects after index date for each cohort.
• Data analysis plan:
  Descriptive statistics (Minimum, maximum, mean, standard deviation, frequency, and percentage) of each of the registered variables will be used to describe and evaluate the baseline characteristics of the cohorts. To evaluate the homogeneity of the groups, it will be calculated the differences between the means and standard deviation with respect to one of the group's pre and post-matching. And homogeneity for categorical variables would be done by comparison of the frequency distribution across levels of the variable.For the main analysis, generalized linear mixed models (GLMM) will be used to evaluate changes in clinical parameters between groups during follow-up. Average changes or reductions in average means per temporal unit will be estimated after treatment. COX regression models will be used to estimate the risk of achieving the combined objective(reduction of HbA1c of at least 0.5%, weight reduction of at least 3% or both) during follow-up.