Diabetes, Insulin and Malignancies Study New User Protocol (DIMSum)

Study identification

• EU PAS number:
  EUPAS2333
• Study ID:
  25978
• Official title and acronym:
  Diabetes, Insulin and Malignancies Study New User Protocol (DIMSum)
• DARWIN EU® study:
  No
• Study countries:
  United States
• Study description:
  This study utilizes a retrospective cohort design in which subjects with diabetes enter the cohort at the time of first use of insulin (glargine or NPH), and baseline information is obtained from a fixed period of time prior to first insulin use. New users of glargine will be compared with new users of NPH insulin with respect to incidence of breast, colon and prostate cancer (individually) and all cancers combined (excluding non-melanoma skin cancer). Data will be obtained from electronic medical record systems and administrative databases in the US.
• Study status:
  Finalised

Research institutions and networks

Institutions

Collaborative Studies Coordinating Center, Gillings School of Public Health, University of North Carolina at Chapel Hill

Ochsner Health System Louisiana, Partners HealthCare System Massachusetts, MedAssurant Maryland, Solucia Connecticut

Study timelines

Date when funding contract was signed

Actual:09/04/2010

Study start date

Actual:13/09/2010

Data analysis start date

Actual:01/09/2011

Date of final study report

Planned:30/06/2012

Actual:22/07/2013

Sources of funding

Pharmaceutical company and other private sector 

More details on funding

Sanofi-aventis

Regulatory

• Was the study required by a regulatory body?:
  No
• Is the study required by a Risk Management Plan (RMP)?:
  Not applicable