An observational study of patient cohorts who previously received long-term treatment with pioglitazone or placebo in addition to existing antidiabetic medications

Study identification

• PURI:
  https://redirect.ema.europa.eu/resource/15774
• EU PAS number:
  EUPAS10513
• Study ID:
  15774
• Official title and acronym:
  An observational study of patient cohorts who previously received long-term treatment with pioglitazone or placebo in addition to existing antidiabetic medications
• DARWIN EU® study:
  No
• Study countries:
  Austria

  Belgium

  Czechia

  Denmark

  Estonia

  Finland

  France

  Germany

  Hungary

  Latvia

  Lithuania

  Netherlands

  Norway

  Poland

  Slovakia

  Sweden

  Switzerland

  United Kingdom
• Study description:
  The risk reduction by pioglitazone in cardiovascular (CV) outcomes in patients with Type 2 diabetes mellitus (T2DM) and pre-existing macrovascular disease was previously evaluated during PROactive study. This 10-year observational, multicenter study was conducted as a follow-up of PROactive study to investigate the CV and macrovascular effects observed with pioglitazone overtime during PROactive. In this study, high risk T2DM patients previously enrolled in PROactive were analyzed for long-term incidence, nature, and pattern of all malignancies in pioglitazone-treated and placebo-treated groups. The planned total duration of the study is 10 years, with data being analyzed and reported every 2 years (starting July 2007). Patients were assessed at nominal visits every 6 months and every effort was made to obtain as much of the required information as possible.
• Study status:
  Finalised

Research institutions and networks

Institutions

Takeda

Multiple centres: 18 centres are involved in the study

Study timelines

Date when funding contract was signed

Planned: 02/11/2004

Actual: 02/11/2004

Study start date

Planned: 02/11/2004

Actual: 02/11/2004

Date of final study report

Planned: 19/07/2011

Actual: 19/07/2011

Sources of funding

Pharmaceutical company and other private sector 

More details on funding

Takeda

Study protocol

Initial protocol

AD-4833-EC445-Protocol

Updated protocol

AD-4833-EC445-Protocol Amendment 2

Regulatory

• Was the study required by a regulatory body?:
  No
• Is the study required by a Risk Management Plan (RMP)?:
  EU RMP category 3 (required)