Status: Finalised First registered on: 07/11/2016
Last updated on: 27/04/2017
1. Study identification
EU PAS Register NumberEUPAS16082
Official titlePioglitazone Use and Risk of Bladder Cancer: a Systematic Review and Meta-Analysis of Observational Studies
Study title acronym
Study typeOther: Systematic review and meta-analysis
Brief description of the studyThe primary research question is whether type 2 diabetes mellitus patients treated with pioglitazone are at a higher risk of bladder cancer compared to type 2 diabetes mellitus patients who are not treated with pioglitazone. The secondary research question is whether the risk of bladder cancer is increased by cumulative exposure duration or cumulative dose of pioglitazone. This meta-analysis will be based on a systematic and comprehensive literature review that will be conducted to identify eligible observational studies from peer-reviewed scientific journals.
Was this study requested by a regulator?No
Is the study required by a Risk Management Plan (RMP)? Not applicable
Regulatory procedure number (RMP Category 1 and 2 studies only)
Other study registration identification numbers and URLs as applicable
2. Research centres and Investigator details
Coordinating study entity
Centre to which the investigator belongsEPID Research
Department/Research group
Organisation/affiliationEPID Research Oy
Website/Homepagewww.epidresearch.com
Details of (Primary) lead investigator
Title Dr
Last name Korhonen
First name Pasi
Is this study being carried out with the collaboration of a research network?
No
Other centres where this study is being conducted
Not applicable (single centre)

Countries in which this study is being conducted
National study

Finland
3. Study timelines: initial administrative steps, progress reports and final report
PlannedActual
Date when funding contract was signed02/08/201602/08/2016
Start date of data collection28/10/201628/10/2016
Start date of data analysis
Date of interim report, if expected
Date of final study report31/12/201618/04/2017
4. Sources of funding
Please provide estimates of the percentage of funding by source for this study
Names(s)Approximate % funding
Pharmaceutical companiesTakeda Development Centre Europe Ltd100
Charities
Government body
Research councils
EU funding scheme
5. Contact details for enquiries
Scientific Enquiries
Title Dr
Last name Korhonen
First name Pasi
Address line 1EPID Research Oy
Address line 2Metsänneidonkuja 12 
Address line 3 
CityEspoo 
Postcode02130 
CountryFinland
Phone number (incl. country code)358-50-3652990 
Alternative phone number 
Fax number (incl. country code) 
Email address pasi.korhonen@epidresearch.com
Public Enquiries
Title Dr 
Last name Hoti 
First name Fabian 
Address line 1EPID Research Oy 
Address line 2Metsänneidonkuja 12 
Address line 3 
CityEspoo 
Postcode02130 
CountryFinland 
Phone number (incl. country code)358-40-5391919 
Alternative phone number 
Fax number (incl. country code) 
Email address fabian.hoti@epidresearch.com 
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