Study type

Study topic

Disease /health condition
Human medicinal product

Study type

Non-interventional study

Scope of the study

Assessment of risk minimisation measure implementation or effectiveness
Drug utilisation

Data collection methods

Secondary use of data
Non-interventional study

Non-interventional study design

Cohort
Cross-sectional
Study drug and medical condition

Anatomical Therapeutic Chemical (ATC) code

(A10BD15) metformin and dapagliflozin
metformin and dapagliflozin

Medical condition to be studied

Type 2 diabetes mellitus
Population studied

Short description of the study population

All patients identified in the Cegedim database for at least one year prior to the first prescription and who newly received at least one dapagliflozin prescription during the study period.

Age groups

  • Adult and elderly population (≥18 years)
    • Adults (18 to < 65 years)
      • Adults (18 to < 46 years)
      • Adults (46 to < 65 years)
    • Elderly (≥ 65 years)
      • 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

7109
Study design details

Main study objective

The main objective of the study is to describe the characteristics of patients newly prescribed dapagliflozin by age, sex, dapagliflozin dose, country, co-morbidities, and concomitant medications in all new users and the following subgroups: patients > 75 years-old, with combination use with loop diuretics or pioglitazone, with a history of renal impairment and patients not reported to have T2DM.

Data analysis plan

Descriptive statistics will be calculated to describe baseline characteristics among dapagliflozin initiators. These characteristics include age group, sex, initial dapagliflozin dose, country, BMI, eGFR, co-morbidities, concomitant medications, and available results of laboratory testing. We will also describe dapagliflozin use within and outside the labeled indication of type 2 diabetes.Qualitative variables will be described by frequencies and percentages. For each class, number of missing values will be presented. Quantitative variables will be described with number of observed data, mean, standard deviation, median, first and third quartiles, and number of missing values.In order to assess the impact of missing data, key variables (e.g. BMI and eGRF) will be checked by describing patients with and without missing values, respectively, regarding basic characteristics available for all or most patients, including age, gender, country, co-medication and co-morbidity.