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 The importance of biodiversity in forests could increase due to climate change
17.11.2017 | Deutsches Zentrum für integrative Biodiversitätsforschung (iDiv) Halle-Jena-Leipzig

nachricht Win-win strategies for climate and food security
02.10.2017 | International Institute for Applied Systems Analysis (IIASA)

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: A “cosmic snake” reveals the structure of remote galaxies

The formation of stars in distant galaxies is still largely unexplored. For the first time, astron-omers at the University of Geneva have now been able to closely observe a star system six billion light-years away. In doing so, they are confirming earlier simulations made by the University of Zurich. One special effect is made possible by the multiple reflections of images that run through the cosmos like a snake.

Today, astronomers have a pretty accurate idea of how stars were formed in the recent cosmic past. But do these laws also apply to older galaxies? For around a...

Im Focus: Visual intelligence is not the same as IQ

Just because someone is smart and well-motivated doesn't mean he or she can learn the visual skills needed to excel at tasks like matching fingerprints, interpreting medical X-rays, keeping track of aircraft on radar displays or forensic face matching.

That is the implication of a new study which shows for the first time that there is a broad range of differences in people's visual ability and that these...

Im Focus: Novel Nano-CT device creates high-resolution 3D-X-rays of tiny velvet worm legs

Computer Tomography (CT) is a standard procedure in hospitals, but so far, the technology has not been suitable for imaging extremely small objects. In PNAS, a team from the Technical University of Munich (TUM) describes a Nano-CT device that creates three-dimensional x-ray images at resolutions up to 100 nanometers. The first test application: Together with colleagues from the University of Kassel and Helmholtz-Zentrum Geesthacht the researchers analyzed the locomotory system of a velvet worm.

During a CT analysis, the object under investigation is x-rayed and a detector measures the respective amount of radiation absorbed from various angles....

Im Focus: Researchers Develop Data Bus for Quantum Computer

The quantum world is fragile; error correction codes are needed to protect the information stored in a quantum object from the deteriorating effects of noise. Quantum physicists in Innsbruck have developed a protocol to pass quantum information between differently encoded building blocks of a future quantum computer, such as processors and memories. Scientists may use this protocol in the future to build a data bus for quantum computers. The researchers have published their work in the journal Nature Communications.

Future quantum computers will be able to solve problems where conventional computers fail today. We are still far away from any large-scale implementation,...

Im Focus: Wrinkles give heat a jolt in pillared graphene

Rice University researchers test 3-D carbon nanostructures' thermal transport abilities

Pillared graphene would transfer heat better if the theoretical material had a few asymmetric junctions that caused wrinkles, according to Rice University...

All Focus news of the innovation-report >>>

Anzeige

Anzeige

Event News

Ecology Across Borders: International conference brings together 1,500 ecologists

15.11.2017 | Event News

Road into laboratory: Users discuss biaxial fatigue-testing for car and truck wheel

15.11.2017 | Event News

#Berlin5GWeek: The right network for Industry 4.0

30.10.2017 | Event News

 
Latest News

Antarctic landscape insights keep ice loss forecasts on the radar

20.11.2017 | Earth Sciences

Filling the gap: High-latitude volcanic eruptions also have global impact

20.11.2017 | Earth Sciences

Water world

20.11.2017 | Life Sciences

VideoLinks
B2B-VideoLinks
More VideoLinks >>>