Status: FinalisedLast updated on: 30/10/2012
1. Study identification
EU PAS Register NumberEUPAS3105
Official titleGlargine and risk of cancer
Study title acronymGROC
Study typeObservational study
Brief description of the studyA suspected higher risk of cancer in insulin glargine (IG) than in human insulin (HI) users was investigated in the EGB database, a permanent representative sample of the French national healthcare insurance database, over the period from January 1st, 2003 to June 30th, 2010. Methods: Cox proportional hazards time-dependent models stratified on the propensity score quartiles for use of IG vs. HI, and adjusted on insulin, biguanide and sulfonylurea possession rates were used to assess the risk of cancer or death in incident or all exclusive or predominant (≥ 80% use time) IG users compared to equivalent HI users. Results: Only type 2 diabetic patients were studied. Exposures varied from 2273 and 614 patient-years for incident exclusive IG or HI users respectively, to 3125 and 2341 patient-years for all predominant IG or HI users. All-type cancer hazard ratios (HR) with IG vs. HI ranged from 0.59 (95% confidence interval (CI) 0.28, 1.25) in incident exclusive users to 0.58 (95%CI 0.34, 1.01) in all predominant users. Cancer risk increased with exposure to insulin or sulfonylureas in these patients. Adjusted HR for death or cancer associated with IG compared to HI ranged from 0.58 (95%CI 0.32, 1.06) to 0.56 (95%CI 0.36, 0.87). Conclusion: There was no excess risk of cancer in type 2 diabetic patients on insulin glargine alone compared to human insulin alone. The overall risk of death or cancer in patients on glargine was about half that of patients on HI, thereby excluding bias from competing risk of death.
Was this study requested by a regulator?Yes: France
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 to which the investigator belongsBordeaux PharmacoEpi
Department/Research grouppharmacoepidemiology
Organisation/affiliationUniversity of Bordeaux
Website/Homepagewww.pharmacoepi.eu
Details of (Primary) lead investigator
Title Dr
Last name Blin
First name Patrick
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

France
3. Study timelines: initial administrative steps, progress reports and final report
PlannedActual
Date when funding contract was signed18/10/2010
Start date of data collection07/12/2010
Start date of data analysis14/02/2011
Date of interim report, if expected
Date of final study report20/09/2011
4. Sources of funding
Please provide estimates of the percentage of funding by source for this study
Names(s)Approximate % funding
Pharmaceutical companiesSanofi80
Charities
Government body
Research councils
EU funding scheme
OtherUniversity of Bordeaux20
5. Contact details for enquiries
Scientific Enquiries
Title Dr
Last name Blin
First name Patrick
Address line 1Dept pharmacology - Univ Bordeaux
Address line 2Rue Eugène Jacquet 
Address line 3Case 41 
CityBordeaux 
Postcode33076 
CountryFrance
Phone number (incl. country code)33557573747 
Alternative phone number 
Fax number (incl. country code) 
Public Enquiries
Title Dr 
Last name Blin 
First name Patrick 
Address line 1146 Rue Leo Saignat 
Address line 2 
Address line 3 
CityBordeaux 
Postcode33076 
CountryFrance 
Phone number (incl. country code)33557574737 
Alternative phone number33557571560 
Fax number (incl. country code)33557574671 
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