Study identification

EU PAS number

EUPAS9995

Study ID

14797

Official title and acronym

A study on the utilization of pioglitazone in clinical practice in the UK after the label change in July 2011

DARWIN EU® study

No

Study countries

United Kingdom

Study description

This study aims to describe the prescription pattern of pioglitazone in diabetic patients within the UK after the label change in July 2011 and measure the effectiveness of the additional risk minimization activities related to pioglitazone, as there have been safety concerns for pioglitazone regarding bladder cancer, heart failure (HF), and off label use as first-line therapy. Data will be obtained from the UK based Clinical Practice Research Datalink (CPRD) during a study period between 21 July 2011 and the end of December 2013. Cumulative incidence rates (CIRs) of HF in incident and prevalent pioglitazone users will be calculated separately, stratified according to whether or not insulin was co-prescribed. Study will further assess prescription patterns regarding the previously implemented risk minimization measures for pioglitazone, i.e. the proportion of stopped therapy following an incident diagnosis for bladder cancer, macroscopic hematuria, or an unacceptably high HbA1c level in incident and prevalent pioglitazone users separately.

Study status

Finalised
Research institutions and networks

Institutions

Contact details

Christoph Meier

Primary lead investigator

Study timelines

Date when funding contract was signed

Actual:

Study start date

Actual:

Data analysis start date

Actual:

Date of final study report

Actual:
Sources of funding
Pharmaceutical company and other private sector 

More details on funding

TDC Europe
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)