Study type

Study type

Non-interventional study

Scope of the study

Effectiveness study (incl. comparative)
Non-interventional study

Non-interventional study design

Cohort
Study drug and medical condition

Anatomical Therapeutic Chemical (ATC) code

(A10BH) Dipeptidyl peptidase 4 (DPP-4) inhibitors
Dipeptidyl peptidase 4 (DPP-4) inhibitors
(A10BB) Sulfonylureas
Sulfonylureas
(A10BG) Thiazolidinediones
Thiazolidinediones
(A10) DRUGS USED IN DIABETES
DRUGS USED IN DIABETES
(A10BX02) repaglinide
repaglinide

Medical condition to be studied

Type 2 diabetes mellitus
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

20000
Study design details

Main study objective

To compare the time to treatment intensification in patients with type 2 diabetes receiving incretin-based medicines versus other non-insulin antidiabetics as add-on therapy to metformin.

Outcomes

Treatment intensification, i.e. insulin initiation or add-on of a third non-insulin antidiabetic, 1) insulin initiation 2) add-on of a third non-insulin antidiabetic drug3) switch to a third non-insulin antidiabetic drug

Data analysis plan

Survival curves describing the time to treatment intensification will be plotted with the Kaplan-Meier method. The log rank test will be used to test the statistical significance of the difference between different groups.Cox regression models will be applied to estimate hazard ratios, with 95% confidence intervals, and compare the time to treatment intensification from index prescription in patients treated with MET+DPP4i versus those in the other exposure categories. Variables measured at baseline will be included in the model to account for their potential confounding effect.
Documents
Study publications
Time to Treatment Intensification in Patients Receiving DPP4 Inhibitors Versus …