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At a glance: The ONWARDS insulin icodec trials

A round-up of the ONWARDS phase 3 clinical trials evaluating the novel weekly insulin icodec in people with diabetes.
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Diabetologia
Published in: Diabetologia 4/2010

Open Access 01-04-2010 | Letter

Insufficient evaluation of adverse events is not a proof of safety. Reply to LG Hemkens, U Grouven, R Bender, et al. [letter]

Authors: P. D. Home, P. Lagarenne

Published in: Diabetologia | Issue 4/2010

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Excerpt

To the Editor: We read the letter from Hemkens et al. with interest [1]. We find it flawed with respect to scientific method, as well as inappropriate in its suggestion of a potentially more detailed statistical method. First, we need to comment that in our analysis we have taken the highest level of evidence available for the relationship between malignancy and use of insulin glargine (A21Gly, B31Arg, B32Arg human insulin), randomised controlled trials, and put it in the public domain. In our article, we observe (but do not interpret) the data, and only state that the use of insulin glargine in the circumstances of the studies included is not associated with any reduction or increase in malignancy rates. …
Literature
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Currie CJ, Poole CD, Gale EAM (2009) The influence of glucose-lowering therapies on cancer risk in type 2 diabetes. Diabetologia 52:1766–1777CrossRefPubMed
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Hemkens LG, Grouven U, Bender R et al (2009) Risk of malignancies in patients with diabetes treated with human insulin or insulin analogues: a cohort study. Diabetologia 52:1732–1744CrossRefPubMed
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Colhoun HM, SDRN Epidemiology Group (2009) Use of insulin glargine and cancer incidence in Scotland: a study from the Scottish Diabetes Research Network Epidemiology Group. Diabetologia 52:1755–1765. Erratum Diabetologia 52:2469
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Jonasson JM, Ljung R, Talback M, Haglund B, Gudbjornsdottir S, Steineck G (2009) Insulin glargine use and short-term incidence of malignancies—a population-based follow-up study in Sweden. Diabetologia 52:1745–1754CrossRefPubMed
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Garg SK, Hirsch IB, Skyler JS (2009) Insulin glargine and cancer—an unsubstantiated allegation. Diabetes Technol Ther 11:473–476CrossRefPubMed
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Pocock SJ, Smeeth L (2009) Insulin glargine and malignancy: an unwarranted alarm. Lancet 374:511–513CrossRefPubMed
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Smeeth L, Pocock SJ (2009) Insulin glargine and cancer—author’s reply. Lancet 374:1744CrossRef
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Rosenstock J, Fonseca V, McGill JB et al (2009) Similar risk of malignancy with insulin glargine and neutral protamine Hagedorn (NPH) insulin in patients with type 2 diabetes: findings from a 5 year randomised, open-label study. Diabetologia 52:1971–1973CrossRefPubMed
Metadata
Title
Insufficient evaluation of adverse events is not a proof of safety. Reply to LG Hemkens, U Grouven, R Bender, et al. [letter]
Authors
P. D. Home
P. Lagarenne
Publication date
01-04-2010
Publisher
Springer-Verlag
Published in
Diabetologia / Issue 4/2010
Print ISSN: 0012-186X
Electronic ISSN: 1432-0428
DOI
https://doi.org/10.1007/s00125-009-1656-5

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