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DIRECT

Diabetes research on patient stratification

Summary

Diabetes treatment gets personal

Type 2 diabetes patients are a diverse group; in some, the disease progresses rapidly, while in others it takes a slower course. Similarly, a treatment that works well in one patient may prove less effective in another. This has led researchers to acknowledge that there are actually a number of different subtypes of type 2 diabetes. The goal of the IMI-funded DIRECT project is to identify these subtypes and determine most appropriate treatments for them. The project brings together Europe’s leading researchers from academia, healthcare, and the pharmaceutical industry.

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Some 285 million people worldwide have type 2 diabetes, and that figure is set to rise to 439 million by 2030. It arises when the body cannot make enough insulin (the hormone responsible for managing blood sugar levels), or when the body fails to respond to insulin. Although type 2 diabetes is a chronic, lifelong condition, it can be managed through a combination of medicines and lifestyle changes. If left unmanaged, patients’ blood sugar levels become too high, triggering damage to the cardiovascular system, kidneys, eyes, and nerve endings.

Although there are a number of risk factors for type 2 diabetes (such as obesity), it is not always clear why some people develop the condition while others do not. Furthermore, the course of the disease and the effectiveness of different medicines vary from one patient to another. In other words, there are a number of different kinds of type 2 diabetes, and that is where the DIRECT project comes in.

Variations on a theme
The focus of the DIRECT project is patient stratification, which involves identifying different subgroups of patients. The project will develop and validate tests to predict who will get diabetes, whose condition will deteriorate rapidly after diagnosis, and who will respond well or badly to certain drugs. The tests will then allow the DIRECT project to determine which existing drugs are effective for different varieties of type 2 diabetes.

DIRECT will gather large amounts of data as well as samples from people at risk of diabetes, people with diabetes, and people undergoing diabetes treatment. This will enable the project team to identify biomarkers (biological markers such as the level of a certain molecule in the blood) associated with different subtypes of type 2 diabetes and different rates of disease progression. These biomarkers will then be tested in prospective clinical trials, paving the way for their use as new diagnostic tests as well as in the creation of personalised therapies. Getting the right treatments to the right patients.

The tests developed by DIRECT will ultimately usher in a new era of personalised medicine for diabetes patients. In practice, this means doctors will be able to diagnose their patients more accurately and tailor treatments to suit their own particular subtype of type 2 diabetes. In this way, patients will be able to manage their condition more effectively and hopefully avoid the complications associated with diabetes. Furthermore, patients who are at risk of diabetes could be identified and monitored.

A boost for the drug development sector
The work carried out under the DIRECT project will substantially boost industry’s understanding of the underlying causes of type 2 diabetes, helping it to develop tailored treatments that can be targeted to the right patients.

Pieces of a pharma puzzle
The work carried out in DIRECT complements the efforts of IMI’s other diabetes projects. IMIDIA (‘Improving beta-cell function and identification of diagnostic biomarkers for treatment monitoring in diabetes’) is studying the beta cells of the pancreas, which are responsible for producing insulin, with a view to developing a cure for diabetes. Meanwhile SUMMIT (‘Surrogate markers for micro- and macro-vascular hard endpoints for innovative diabetes tools’) is developing tools to identify the patients at greatest risk of developing complications relating to diabetes.

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Achievements & News

IMI diabetes projects deepen cooperation
IMI’s three diabetes projects – IMIDIASUMMIT  and DIRECT  – are set to deepen their cooperation following the signature of a new Memorandum of Understanding (MoU) that formally creates the ‘IMI Diabetes Platform’. ‘With a combined budget of ###€100 million and the involvement of over 300 leading experts in diabetes, this is one of the world’s leading initiatives in this area focusing on overcoming key bottlenecks for novel therapies and improved disease management,’ the projects write in a press release  announcing the MoU. ‘The importance of the findings of the IMI diabetes projects will be strongly increased by the multiple opportunities for information exchange now enabled by the implementation of a formal collaboration framework for the IMI Diabetes Platform.’ The projects have already been collaborating informally for some time. For example, they jointly organised a symposium to present their results at the recent annual meeting of the European Association for the Study of Diabetes (EASD) in Barcelona.
(October 2013)

IMI diabetes projects sign Memorandum of Understanding
IMI currently has three projects working on diabetes – DIRECT, SUMMIT, and IMIDIA – which have a combined budget of###just over€100 million. The projects tackle diabetes in different ways. For example, IMIDIA focuses on studying the pancreatic beta cells which are responsible for producing insulin; it aims to use this knowledge develop treatments that can slow down the progress of diabetes. Meanwhile, SUMMIT’s work addresses the urgent need for new treatments to tackle the complications associated with diabetes, such as eye, kidney, and blood vessel problems. Finally, DIRECT takes a personalised medicine approach to diabetes, as it works to identify different varieties of diabetes and effective treatments to tackle them. The projects already work together on an informal basis (as evidenced by their new joint leaflet produced with the support of the IMI Executive Office). However, IMIDIA and SUMMIT have now taken their collaboration to a new level with the signature of a Memorandum of Understanding (MoU). The MoU covers the handling of intellectual property, the transfer of knowledge and materials, and confidentiality. The projects believe that the MoU could serve as a template for collaboration between other IMI projects in the future.
(November 2012)

Participants

EFPIA 

  • Sanofi-Aventis Deutschland GmbH, Frankfurt am Main, Germany
  • Eli Lilly and Company Ltd, Hampshire, UK
  • Institut de Recherches Internationales Servier, Suresnes, France
  • Novo Nordisk A/S, Bagsværd, Denmark

Universities, research organisations, public bodies, non-profit groups

  • University of Dundee, Dundee, UK
  • Centre Hospitalier Regional et Universitaire de Lille, Lille, France
  • Centre National de la Recherche Scientifique. Paris, France
  • Consiglio Nazionale delle Ricerche, Rome, Italy
  • Consorci Institut d'Investigacions Biomediques August Pi i Sunyer, Barcelona, Spain
  • Eberhard Karls Universität Tübingen, Tübingen, Germany
  • Helmholtz Zentrum München – Deutsches Forschungszentrum für Gesundheit und Umwelt GmbH, Neuherberg, Germany
  • Imperial College of Science, Technology and Medicine, London, UK
  • Kungliga Tekniska Högskolan, Stockholm, Sweden
  • Leiden University Medical Center, Leiden, the Netherlands
  • Lunds Universitet, Lund, Sweden
  • Technical University of Denmark, Kgs. Lyngby, Denmark
  • Universität Ulm, Ulm/Donau, Germany
  • Université de Genève, Geneva, Switzerland
  • University of Bath, Bath, UK
  • University of Copenhagen, Copenhagen, Denmark
  • University of Eastern Finland, Kuopio, Finland
  • University of Exeter, Exeter, UK
  • University of Newcastle upon Tyne, Newcastle upon Tyne, UK
  • University of Oxford, Oxford, UK
  • Vereniging voor christelijk hoger onderwijs, wetenschappelijk onderzoek en patiëntenzorg, Amsterdam, Netherlands 

Facts & Figures

Start date 01/01/2012
Duration  60 months
   
Contributions   
IMI funding 21 400 000
EFPIA in kind 16 500 000
Other   5 200 000
Total cost 43 100 000

Contact

Project Coordinator
Hartmut Rütten

Sanofi
Tel: +49 69 305 13547
E-mail: hartmut.ruetten[AT]sanofi.com

Managing Entity
Ewan Pearson

University of Dundee
Tel: +44 1382 740081
E-mail: e.z.pearson[AT]dundee.ac.uk

Press Contact
Bernd Jablonka
Sanofi
Tel: +49 69 305 5955
E-mail: bernd.jablonka[AT]sanofi.com