Cohort Study of Pioglitazone and Cancer Incidence in Patients with Diabetes Mellitus

Study identification

• PURI:
  https://redirect.ema.europa.eu/resource/14909
• EU PAS number:
  EUPAS10335
• Study ID:
  14909
• Official title and acronym:
  Cohort Study of Pioglitazone and Cancer Incidence in Patients with Diabetes Mellitus
• DARWIN EU® study:
  No
• Study countries:
  United States
• Study description:
  The correlation between thiazolidinedione usage among diabetic patients and cancer risk has been studied previously. However, the most important limitation was the very short-term exposure to pioglitazone. In this cohort study, a large population of diabetic patients was identified from the Kaiser Permanente of Northern California (KPNC) Diabetes Registry. The patients were originally planned to be followed-up from January 1, 1997 to December 31, 2005 for the usage of pioglitazone and incidence of cancer. Based on the discussion with Advisory board, it was recommended to increase the study population and duration of follow-up. The follow-up period was extended to June 30, 2012 for the study on pioglitazone usage and cancer incidence in diabetes patients (Study 1). The need to conduct an epidemiology study of diabetes and cancer risk (Study 2) was also identified in order to assess the association between diabetes severity and cancer risk. The Study 2 included diabetes patients who were KPNC members between 1997 and 2011. It also included a subset of patients who took the 1996/7 diabetes survey and Member Health Survey (MHS) in 1993, 199, 1999, 2001 or 2003.
• Study status:
  Finalised

Research institutions and networks

Institutions

Takeda

Keiser Permente Northern California USA, University of Pennsylvania USA

Study timelines

Date when funding contract was signed

Planned: 01/01/1996

Actual: 01/01/1996

Study start date

Planned: 01/01/1997

Actual: 01/01/1997

Date of interim report, if expected

Planned: 01/09/2011

Actual: 01/09/2011

Date of final study report

Planned: 01/09/2011

Actual: 29/05/2015

Sources of funding

Pharmaceutical company and other private sector 

More details on funding

Takeda

Study protocol

Initial protocol

AD4833-403 Protocol KPNC other malignancies_4

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)