Status: OngoingLast updated on: 24/01/2012
1. Study identification
EU PAS Register NumberEUPAS2333
Official titleDiabetes, Insulin and Malignancies Study New User Protocol
Study title acronymDIMSum
Study typeObservational study
Brief description of the studyThis 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.
Was this study requested by a regulator?No
Is the study required by a Risk Management Plan (RMP)?
Other study registration identification numbers and URLs as applicable
2. Research centres and Investigator details
Coordinating study entity
Centre nameCollaborative Studies Coordinating Center, Gillings School of Public Health, University of North Carolina at Chapel Hill
Centre locationChapel Hill, North Carolina, United States
Details of (Primary) lead investigator
Title Dr
Last name Zhou
First name Haibo
Is this study being carried out with the collaboration of a research network?
No
Other centres where this study is being conducted
Multiple centres

In total how many centres are involved in this Study?4
Ochsner Health System, Louisiana
Partners HealthCare System, Massachusetts
MedAssurant, Maryland
Solucia, Connecticut
Countries in which this study is being conducted
National study

United States
3. Study timelines: initial administrative steps, progress reports and final report
PlannedActual
Date when funding contract was signed09/04/2010
Start date of data collection13/09/2010
Start date of data analysis01/09/2011
Date of interim report, if expected
Date of final study report30/06/2012
4. Sources of funding
Please provide estimates of the percentage of funding by source for this study
Names(s)Approximate % funding
Pharmaceutical companiessanofi-aventis100
Charities
Government body
Research councils
EU funding scheme
5. Contact details for enquiries
Scientific Enquiries
Title Dr
Last name Buse
First name John
Address line 1CB#7172, Burnett-Womack 8027
Address line 2School of Medicine, University of North Carolina at Chapel Hill 
Address line 3 
CityChapel Hill, NC 
Postcode27599 
CountryUnited States
Phone number (incl. country code)001-9199660134 
Alternative phone number001-9199236963 
Fax number (incl. country code)001-9199666025 
Email address John_Buse@med.unc.edu
Public Enquiries
Title Dr 
Last name Buse 
First name John 
Address line 1CB#7172, Burnett-Womack 8027 
Address line 2School of Medicine, University of North Carolina at Chapel Hill 
Address line 3 
CityChapel Hill, NC 
Postcode27599 
CountryUnited States 
Phone number (incl. country code)001-9199660134 
Alternative phone number001-9199236963 
Fax number (incl. country code)001-9199666025 
Email address John_Buse@med.unc.edu 
Top