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Insulin Glargine Cancer Risk

Conflicts of interest. Senior Expert at SE Drug Regulatory Agency (MPA)Unit of Drug SafetyFormer member of PhVWP/CHMP EMEAMember of project groups for EMEAProfessor of Pharnacoepidemiology, KIThis presentation represents my personal views / interpretations only. Diabetes Mellitus: cancer risk. T2 DMExcess risks: Colon (30%), pancreas (50%), breast (20%)T1 DMOverall 20% excess risk, obestity/insulin resis-tance Insulin use two-fold greater ca risk vs MetforminMetformin use protective or23

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Insulin Glargine Cancer Risk

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    1. Insulin Glargine – Cancer Risk PhEpi study design Background and hypotheses Ingemar Persson, Senior Expert, MPA and KI

    2. Conflicts of interest Senior Expert at SE Drug Regulatory Agency (MPA) Unit of Drug Safety Former member of PhVWP/CHMP EMEA Member of project groups for EMEA Professor of Pharnacoepidemiology, KI This presentation represents my personal views / interpretations only

    3. Diabetes Mellitus: cancer risk T2 DM Excess risks: Colon (30%), pancreas (50%), breast (20%) T1 DM Overall 20% excess risk, obestity/insulin resis-tance Insulin use two-fold greater ca risk vs Metformin Metformin use protective or neutral effect? Possible mechanisms?

    4. Insulin and cancer High insulin levels – increased cancer risk Insulin as a growth factor, epithelial tumours Secondary increase in IGF-1 Survival and progression of early malignant cells Anti-apoptotic effect Carcinogenesis – time Transformation – many years Development (promotion) of preexisting pre-malignant cells – a few years?

    5. Insulin analogues - cancer Biosynthetic, ’designer’, insulins Increased mitogenic effects DNA synthesis and cell divisions increased Binding to IR or IGF-1 R, stronger and longer Possible mechanism for carcinogenesis Analogues tested in tumour cell lines E.g. colorectal, breast and prostate: increased response to analogues, less for human insulins Glargine: stronger tumour promoting effects? Limitations to in vitro tests acknowleged … but concern raised for analogues/glargine

    6. Carcinogenicity in animals Female rats / mammary tumours Early insulin analogues, increased incidence Glargine similar to other insulins

    7. Preclinical data - Conclusions Concern for insulin analogues (glargine) and cancer risk? Scientific and media attention No firm judgement from preclinical data How to obtain more knowledge? Observational data, in a first line Data from a large German cohort study, the trigger for a joint research initiative

    8. A Safety Signal - How handled? EASD: a hypothesis on an excess cancer risk for insuline glargine, in particular Need for a broadened knowledge base Invited research 4 observational studies (DE, SE, Scotland, UK) Published in Diabetologica, 2009 Regulatory review Scientific debate Learnings: =>How can registry data contribute?

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