Forum for Science, Industry and Business

Sponsored by:     3M 
Search our Site:

 

Rapid-acting insulin analogues in diabetes mellitus type 1 -- superiority not proven

18.07.2007
High-quality long-term studies are lacking -- Not all studies have been fully published

There is currently no evidence available of a superiority of rapid-acting insulin analogues over human insulin in the treatment of adult patients with diabetes mellitus type 1. The evidential value and design of studies available so far are inadequate and do not allow conclusions regarding most patient-relevant therapy goals, such as the reduction in long-term complications or overall mortality. Due to the lack of data, the benefit of rapid-acting insulin analogues in children and adolescents is unclear.

Although one of the manufacturers conducted long-term comparative studies in this group of patients, it is withholding some of the results. This is the result of the final report of the Institute for Quality and Efficiency in Health Care (IQWiG) which was published in June 2007 and for which an English-language summary is now available.

The German Federal Joint Committee commissioned IQWiG to compare the benefit of rapid-acting insulin analogues versus human insulin, as well as to compare the benefit of various rapid-acting insulin analogues with each other. IQWiG assessed all 3 rapid-acting insulin analogues approved in Germany: insulin aspart (tradename in Germany: Novorapid), insulin lispro (tradenames in Germany: Humalog, Liprolog), and insulin glulisine (tradename in Germany: Apidra).

Effects determinable after 6 months at the earliest

The literature search retrieved a total of 9 published comparative studies, in which patients were observed for at least 24 weeks. Only studies with this minimum duration were included, as they give patients sufficient time to adjust to the new medication, and to observe the treatment effects under stable application. Eight of these studies compared either insulin aspart or insulin lispro with human insulin; no such study was available for glulisine. The only study available that compared two analogues referred to glulisine and lispro.

No long-term studies on insulin pump therapy available

Regarding insulin pump therapy, no study lasting at least 24 weeks was available. Therefore, it remains unclear whether patients would benefit and which advantage patients would have by using this form of administration. The same applies to children and adolescents, as only fully published short-term studies are available in this population so far. The company Novo Nordisk sponsored 2 completed long-term studies in children and adolescents. However, to date, both studies have only been partially published. In contrast to the manufacturers Sanofi and Lilly, Novo Nordisk was not prepared to provide the information needed for the report.

Studies not blinded

The conclusions of the 9 studies included in the evaluation are only of limited robustness. None of the studies was blinded, i.e. both the patient and the physician knew which type of insulin was being injected. Without blinding, there is a danger that patients, knowing their type of insulin, behave differently, which would subsequently lead to a bias in the results of the study. Moreover, inconsistent statements on important issues, which could not be clarified, were often made in the study documents.

No conclusions on important therapy goals possible

Even though patients have been treated with insulin analogues for 10 years, it is still unclear as to how these types of insulin affect long-term complications of diabetes type 1, mortality, and the necessity of hospital admissions. Regarding the reduction in blood glucose levels (measured by means of HbA1c), patients treated with insulin aspart had, on average, lower levels. However, these statistical differences were so small that an effect on patients’ health is not to be expected. Insulin lispro may prevent nocturnal hypoglycaemia better than insulin glulisine. The only study that compared these insulin analogues provided first indications, but no reliable evidence.

Rules of a fair comparison violated

In some studies, patients treated with insulin analogues assessed their quality of life as higher and were more satisfied with treatment than patients who injected human insulin. IQWiG did not evaluate this finding as evidence of an additional benefit of insulin analogues, as it was not based on a fair comparison: In the human insulin group, patients were requested to adhere to a fixed injection-meal interval; this was not the case in the insulin analogue group. It is therefore unclear whether the larger treatment satisfaction was caused by the drug class itself, or by the different forms of application prescribed by physicians.

The role of rapid-acting insulin analogues in the treatment of diabetes type 2 was assessed in a separate commission; the relevant final report had already been published by IQWiG in December 2005. This report also came to the conclusion that evidence of an additional benefit of insulin analogues has yet to be provided.

Anna-Sabine Ernst | EurekAlert!
Further information:
http://www.iqwig.de
http://www.iqwig.de/index.449.en.html

More articles from Studies and Analyses:

nachricht First form of therapy for childhood dementia CLN2 developed
25.04.2018 | Universitätsklinikum Hamburg-Eppendorf

nachricht Do microplastics harbour additional risks by colonization with harmful bacteria?
05.04.2018 | Leibniz-Institut für Ostseeforschung Warnemünde

All articles from Studies and Analyses >>>

The most recent press releases about innovation >>>

Die letzten 5 Focus-News des innovations-reports im Überblick:

Im Focus: BAM@Hannover Messe: innovative 3D printing method for space flight

At the Hannover Messe 2018, the Bundesanstalt für Materialforschung und-prüfung (BAM) will show how, in the future, astronauts could produce their own tools or spare parts in zero gravity using 3D printing. This will reduce, weight and transport costs for space missions. Visitors can experience the innovative additive manufacturing process live at the fair.

Powder-based additive manufacturing in zero gravity is the name of the project in which a component is produced by applying metallic powder layers and then...

Im Focus: Molecules Brilliantly Illuminated

Physicists at the Laboratory for Attosecond Physics, which is jointly run by Ludwig-Maximilians-Universität and the Max Planck Institute of Quantum Optics, have developed a high-power laser system that generates ultrashort pulses of light covering a large share of the mid-infrared spectrum. The researchers envisage a wide range of applications for the technology – in the early diagnosis of cancer, for instance.

Molecules are the building blocks of life. Like all other organisms, we are made of them. They control our biorhythm, and they can also reflect our state of...

Im Focus: Spider silk key to new bone-fixing composite

University of Connecticut researchers have created a biodegradable composite made of silk fibers that can be used to repair broken load-bearing bones without the complications sometimes presented by other materials.

Repairing major load-bearing bones such as those in the leg can be a long and uncomfortable process.

Im Focus: Writing and deleting magnets with lasers

Study published in the journal ACS Applied Materials & Interfaces is the outcome of an international effort that included teams from Dresden and Berlin in Germany, and the US.

Scientists at the Helmholtz-Zentrum Dresden-Rossendorf (HZDR) together with colleagues from the Helmholtz-Zentrum Berlin (HZB) and the University of Virginia...

Im Focus: Gamma-ray flashes from plasma filaments

Novel highly efficient and brilliant gamma-ray source: Based on model calculations, physicists of the Max PIanck Institute for Nuclear Physics in Heidelberg propose a novel method for an efficient high-brilliance gamma-ray source. A giant collimated gamma-ray pulse is generated from the interaction of a dense ultra-relativistic electron beam with a thin solid conductor. Energetic gamma-rays are copiously produced as the electron beam splits into filaments while propagating across the conductor. The resulting gamma-ray energy and flux enable novel experiments in nuclear and fundamental physics.

The typical wavelength of light interacting with an object of the microcosm scales with the size of this object. For atoms, this ranges from visible light to...

All Focus news of the innovation-report >>>

Anzeige

Anzeige

VideoLinks
Industry & Economy
Event News

Invitation to the upcoming "Current Topics in Bioinformatics: Big Data in Genomics and Medicine"

13.04.2018 | Event News

Unique scope of UV LED technologies and applications presented in Berlin: ICULTA-2018

12.04.2018 | Event News

IWOLIA: A conference bringing together German Industrie 4.0 and French Industrie du Futur

09.04.2018 | Event News

 
Latest News

The dispute about the origins of terahertz photoresponse in graphene results in a draw

25.04.2018 | Physics and Astronomy

Graphene origami as a mechanically tunable plasmonic structure for infrared detection

25.04.2018 | Materials Sciences

First form of therapy for childhood dementia CLN2 developed

25.04.2018 | Studies and Analyses

VideoLinks
Science & Research
Overview of more VideoLinks >>>