DARWIN EU® - Characterisation of acute renal outcomes and diabetic complications among patients with concomitant use of metformin and iodinated contrast agents

Study type

• Study topic:
  Disease /health condition

  Human medicinal product
• Study type:
  Non-interventional study
• Scope of the study:
  Disease epidemiology
• Data collection methods:
  Secondary use of data

Non-interventional study

• Non-interventional study design:
  Cohort

Study drug and medical condition

• Medicinal product name, other:
  Metformin, iodinated contrast agents
• Study drug International non-proprietary name (INN) or common name:
  METFORMIN
• Anatomical Therapeutic Chemical (ATC) code:
  (A10BA02) metformin

  metformin

Population studied

• Short description of the study population:
  1) Cohort 1: Patients with type 2 diabetes initiating metformin. ; 2) Cohort 2: Patients with type 2 diabetes on metformin undergoing their first procedure requiring ICA.
• Age groups:
  • In utero
  • Paediatric Population (< 18 years)

    • Neonate

      • Preterm newborn infants (0 – 27 days)
      • Term newborn infants (0 – 27 days)
    • Infants and toddlers (28 days – 23 months)
    • Children (2 to < 12 years)
    • Adolescents (12 to < 18 years)
  • 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)

Study design details

• Study design:
  Retrospective cohort studies will be conducted using routinely collected health data from 4 databases.
• Main study objective:
  1. To characterise patients with type 2 diabetes initiating treatment of metformin in terms of:; a. Demographics (age, sex); b. Recorded comorbidities ; c. Recorded duration from first diabetes diagnosis; d. Previous procedures with ICA, including phenotyping; e. CKD stage (most recent in past year), including phenotyping ; 2. To characterise patients with type 2 diabetes with a first procedure requiring ICA with ongoing metformin use in terms of :; a. Demographics (age, sex); b. Comorbidities ; c. Recorded duration from first diabetes diagnosis; d. CKD stage; e. ICA type ; f. Time from metformin initiation to first procedure requiring ICA; 3. To quantify the occurrence of renal dysfunction and of acute diabetes decompensation among patients with type 2 diabetes with a first procedure requiring ICA during metformin use specifically:; a. AKI, including phenotyping; b. Lactic acidosis ; c. Diabetic ketoacidosis ; d. Change in eGFR and CKD status before and after date of first procedure requiring ICA;
• Setting:
  This study was conducted using routinely collected data from 4 data sources from 4 European countries. All ; data sources were previously mapped to the Observational Medical Outcomes Partnership Common Data ; Model (OMOP CDM). ; Denmark: Danish Data Health Registries (DK-DHR) ; Finland: Finnish Care Register for Health Care (FinOMOP-THL) ; Spain: The Information System for Research on Primary Care (SIDIAP) ; The United Kingdom: Clinical Practice Research Datalink GOLD (CPRD GOLD)
• Outcomes:
  The outcomes of the study were related to acute renal outcomes and acute diabetic complications. ; We quantified the following outcomes among patients who had a first procedure requiring ICA during ; ongoing metformin use: ; • AKI ; • Lactic acidosis ; • Diabetic ketoacidosis ; • Change in eGFR or CKD status before and after date of first procedure requiring ICA ; The study outcomes are described conceptually, and the context or rationale for the choices are provided ; in this section. The operational definition of the outcomes is presented in Table S6.