Cancer risk estimation study program in patients treated with insulin in France (GROC)

Study identification

• PURI:
  https://redirect.ema.europa.eu/resource/40861
• EU PAS number:
  EUPAS3105
• Study ID:
  40861
• Official title and acronym:
  Cancer risk estimation study program in patients treated with insulin in France (GROC)
• DARWIN EU® study:
  No
• Study countries:
  France
• Study description:
  A 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.
• Study status:
  Finalised

Research institution and networks

Institutions

Bordeaux PharmacoEpi, University of Bordeaux

France

Study timelines

Date when funding contract was signed

Actual: 18/10/2010

Study start date

Actual: 07/12/2010

Data analysis start date

Actual: 14/02/2011

Date of final study report

Actual: 20/09/2011

Sources of funding

Other

Pharmaceutical company and other private sector 

More details on funding

Sanofi, University of Bordeaux

Study protocol

Initial protocol

PAS Lantus 10032011

Updated protocol

Synopsis LANTUS 06122010

Regulatory

• Was the study required by a regulatory body?:
  Yes
• Is the study required by a Risk Management Plan (RMP)?:
  Not applicable