Study identification

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
First published:
01/02/2024
Institution
Multiple centres: 18 centres are involved in the study

Contact details

Erland Erdmann

Primary lead investigator

Study timelines

Date when funding contract was signed

Planned:
Actual:

Study start date

Planned:
Actual:

Date of final study report

Planned:
Actual:
Sources of funding
Pharmaceutical company and other private sector 

More details on funding

Takeda
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)