New insulins and the risk of cancer

Danne, Thomas; Bolinder, Jan

doi:10.1111/j.1742-1241.2009.02275.x

Cited by 3 publications

(4 citation statements)

References 10 publications

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“…Some research suggests that modifying the insulin molecule to alter duration of action not only changes its metabolic effects, but can also alter its mitogenic potency (26). However, much of the research has been in the form of retrospective epidemiological studies, and until further detailed investigations are undertaken, the relationship between these insulin analogues, such as glargine, and cancer will be far from conclusive (27). As indicated above, adipocytokines, secreted predominantly by adipocytes, play a strong role in obesity‐induced carcinogenesis.…”

Section: Complex Relationship Between Obesity Diabetes and Cancermentioning

confidence: 99%

Expression of microRNAs: potential molecular link between obesity, diabetes and cancer

Ali¹,

Ali

Ahmad³

et al. 2011

Obesity Reviews

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Clinicians are routinely challenged in their management of cancer patients because of the complexities of obesity and diabetes that are often found as comorbid conditions. Although attention has been given to optimizing treatment planning for these patients, less attention has been given to manage their obesity and diabetes. This suggests that newer, comprehensive approaches must be developed for the treatment of cancer patients as a 'whole' rather than as a single disease. While the specific pathologies of each are unique, years of research have indicated intimate molecular links between these chronic diseases. The contribution of sedentary lifestyles and poor dietary habits is recognized; however, the precise molecular links are still not well-explored. In addition, emerging evidence suggests the important role of microRNAs (miRNAs) in the development and progression of several diseases, yet their roles in linking obesity, diabetes and cancer are only now beginning to be recognized. It is hoped that miRNAs will serve as novel biomarkers and molecular targets for cancer therapy in patients with comorbid conditions. In this review, we discuss the current understanding of the pathobiology of obesity, diabetes and cancer, and document molecular roles of miRNAs linking cancer with obesity and diabetes.

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Section: Complex Relationship Between Obesity Diabetes and Cancermentioning

confidence: 99%

Expression of microRNAs: potential molecular link between obesity, diabetes and cancer

Ali¹,

Ali

Ahmad³

et al. 2011

Obesity Reviews

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“… Comment: We reviewed the issue of the risk of malignancy in patients treated with insulin analogues extensively in the 2009 Yearbook (5). Several additional position statements and commentaries and some new studies (6–11) have been published since then.…”

Section: New Insulins and The Risk Of Cancermentioning

confidence: 99%

New insulins and insulin therapy

Danne¹,

Bolinder²

2011

International Journal of Clinical Practice

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The introduction of the so-called 'designer' insulins, the insulin analogues, has offered new opportunities in the clinical management of diabetes. Two additional new entities are close to reaching clinical practice. Linjeta TM (formally called VIAject) is not an analogue but rather a different formulation of human insulin which may give it a more rapid onset of action, potentially even faster than the currently available rapid-acting insulin analogues. Degludec TM , on the other hand, is an insulin analogue molecule with an ultra-long clinical profile derived from the soluble multi-hexamer formation, resulting in a continuous slow and stable release of insulin degludec monomers which may last longer than currently available long-acting analogues. As with any new type of drug, the safety of the 'designer' insulins has to be closely scrutinised. Last year the increased cancer risk in diabetes entered the spotlight and the potential role of insulin analogues led to controversial discussions. In spite of recent new in vitro and observational data no new conclusive evidence became available. The need for multiple well-conducted and appropriately designed prospective observational studies to follow up the effectiveness and safety of the new insulins and the new insulin treatment regimens remains. In this chapter it was our mission to chose articles published about ''new insulins'' over the last year that have the most important contribution for the on-going development of ultra-fast-and ultra-long-acting insulin analogs and preparations and their potential side-effects, particularly cancer. This has been done by means of PubMed searches as well as a review of abstracts of the recent large international diabetes meetings such as ADA, EASD and ISPAD. Background: Prandial insulin delivery may influence the postprandial regulation of tissue blood flow. The effect of VIAject with human regular insulin and insulin lispro on postprandial oxidative stress and endothelial function was compared in patients with type 2 diabetes.Methods: Fourteen patients (seven men) aged 61.5 ± 1.8 years, with mean diabetes duration of 6.6 ± 4.6 years and A1c 7.2% ± 0.5%, received a prandial injection of VIAject, human regular insulin and insulin lispro. The postprandial increases in asymmetric dimethylarginine (ADMA) and nitrotyrosine levels were checked at baseline and after a standardised liquid meal test (Ensure Plus), In addition, the postprandial effects on microvascular blood flow, skin oxygenation and vascular elasticity were measured.Results: A significant reduction in the peak postprandial generation of ADMA was found with VIAject treatment compared with human insulin and insulin lispro (VIAject -27.3 ± 22.6 nmol ⁄ l, human insulin 97.7 ± 24.4 nmol ⁄ l and insulin lispro 66.9 ± 33.9 nmol ⁄ l; p < 0.05, respectively). The postprandial increases in nitrotyrosine levels were significantly less after VIAject than after human regular insulin (VIAject -0.22 ± 0.17 vs. human insulin 0.25 ± 0.15 lg ⁄ ml; p < 0.05), whereas nitrotyrosine after...

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“…Therefore, any regulatory decision will be based on a wholistic view integrating epidemiological observational data as well as preclinical studies on possible mechanisms. Overall, data on the effect of insulin glargine on the development of tumours are mostly considered as inconclusive and a change of treatment recommendations or regulatory action seem not justified to experts in the USA [ 17 ] or in Europe [ 2 , 18 , 19 ].…”

Section: Studies On the Potential Cancer Hazard Of Iasmentioning

confidence: 99%

“…In an IA, the human insulin molecule has been altered to modify its pharmacokinetic and/or pharmacodynamic properties. The development of new IAs continues regardless of an ongoing discussion on the safety of these products [ 2 , 3 ]. Most particularly a possible carcinogenic effect of IAs has been considered and since 2001 special recommendations of the European Medicines Agency are available on how to assess a possible carcinogenic potential of a new IA during development [ 4 ].…”

Section: Introductionmentioning

confidence: 99%

Current european regulatory perspectives on insulin analogues

Enzmann

Weise

2011

Diabetol Metab Syndr

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Insulin analogues are increasingly considered as an alternative to human insulin in the therapy of diabetes mellitus. Insulin analogues (IAs) are chemically different from human insulin and may have different pharmacokinetic or pharmacodynamic properties. The significance of the modifications of the insulin molecule for the safety profile of IAs must be considered. This review describes the regulatory procedure and the expectations for the scientific content of European marketing authorization applications for innovative IAs submitted to the European Medicines Agency. Particular consideration is given to a potential cancer hazard. Specific regulatory guidance on how to address a possible carcinogenic or tumor promoting effect of innovative IAs in non-clinical studies is available. After marketing authorization, the factual access of patients to the new product will be determined to great extent by health technology assessment bodies, reimbursement decisions and the price. Whereas the marketing authorization is a European decision, pricing and reimbursement are national or regional responsibilities. The assessment of benefit and risk by the European Medicines Agency is expected to influence future decisions on price and reimbursement on a national or regional level. Collaborations between regulatory agencies and health technology assessment bodies have been initiated on European and national level to facilitate the use of the European Medicines Agency's benefit risk assessment as basis on which to build the subsequent health technology assessment. The option for combined or joint scientific advice procedures with regulators and health technology assessment bodies on European level or on a national level in several European Member States may help applicants to optimize their development program and dossier preparation in regard of both European marketing authorization application and reimbursement decisions.

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New insulins and the risk of cancer

Cited by 3 publications

References 10 publications

Expression of microRNAs: potential molecular link between obesity, diabetes and cancer

Expression of microRNAs: potential molecular link between obesity, diabetes and cancer

New insulins and insulin therapy

Current european regulatory perspectives on insulin analogues

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