Observational single-cohort data base study of dapagliflozin utilisation in Europe (NA)

Study identification

• EU PAS number:
  EUPAS13199
• Study ID:
  18553
• Official title and acronym:
  Observational single-cohort data base study of dapagliflozin utilisation in Europe (NA)
• DARWIN EU® study:
  No
• Study countries:
  Belgium

  France

  Germany

  Italy

  Spain

  United Kingdom
• Study description:
  This drug utilization study is set up to describe the characteristics of European patients newly prescribed dapagliflozin by age, sex, dapagliflozin dose, country, selected co-morbidities, and selected concomitant medications.It will specifically describe dapagliflozin use in:• patients > 75 years-old,• combination use with loop diuretics or pioglitazone,• patients with a known history of moderate or severe renal impairment and in kidney failure,• patients lacking a diagnostic code indicating type 2 diabetes.This is an observational single-cohort data base study with descriptive data analyses among patients receiving dapagliflozin within electronic medical records in Europe. The study will describe the utilization pattern of dapagliflozin during the first 3.5 years after marketing authorization and launch in Europe, specifically in Belgium, France, Germany, Italy, Spain and United Kingdom.Will be included in the study all patients identified in the database(s) who newly received at least one dapagliflozin prescription during the study period. Data will be collected from IMS Health Longitudinal Patient Databases (LPDs) which come directly from physicians’ EMR.A patient will be identified as newly exposed when he/she has at least one dapagliflozin prescription recorded in the study database(s).Outcomes include: Patient demographics: age, sex, country, Baseline history of type 2 diabetes, Baseline history of moderate or severe renal impairment, Concomitant medications at baseline and during dapagliflozin use.Follow-up will begin on the date a patient is first prescribed dapagliflozin, and it will continue until the end of study or discontinuation of dapagliflozin.In this study descriptive analyses of the data will be conducted.
• Study status:
  Finalised

Research institutions and networks

Institutions

Real World Evidence Solutions, IMS Health

France

Study timelines

Date when funding contract was signed

Actual:19/03/2013

Study start date

Actual:01/01/2013

Date of final study report

Planned:12/10/2016

Actual:15/12/2016

Sources of funding

Pharmaceutical company and other private sector 

More details on funding

AstraZeneca

Regulatory

• Was the study required by a regulatory body?:
  Yes
• Is the study required by a Risk Management Plan (RMP)?:
  EU RMP category 3 (required)

Other study registration identification numbers and links

D1690R00006