DIRECT - Innovative Medicines Initiative:
DIabetes REsearCh on patient straTification

Patient/Participant information

People with Type 2 diabetes can have a very different experience. For example, some people’s blood sugar levels will get worse over time and some people’s blood sugar levels will remain the same. Some people experience side effects with common drugs used to treat Type 2 diabetes, while others don’t. Also some people will respond very well to certain treatments but other people respond badly.


The DIRECT project is intended to explore some of these differences, to work out why people don’t react in the same way. We will be able to see whether people with Type 2 diabetes are similar and if they have the same experience or not. This will help predict how other people might respond.


The studies hope to identify if there are signals, called ‘biomarkers’, which might flag whether particular patients belong to different sub-groups. These sub-groups are based on each patient’s experience of Type 2 diabetes. These biomarkers will be used to help diagnose people with Type 2 diabetes, and could be used to choose the best treatment pathways for them.


The first stage of the project is split into two areas:

  • Studying the way that Type 2 diabetes progresses in some patients.
  • Studying the way that different patients respond to different treatments.


The biomarkers found in these studies, will be tested further in the second stage of the project. In the second stage we want to see whether these biomarkers really are helpful in diagnosing people with Type 2 diabetes and in developing better treatments in the future.


The research is being funded by the European Union, with funding from some leading pharmaceutical companies. Together, this group of European researchers and scientists is called the DIRECT Consortium. DIRECT is interested in learning about the risk factors for diabetes and how people with diabetes begin their diabetes journey or respond to treatment.


DIRECT studies have taken place at a number of sites, and over a number of years. The Participant Information Sheet (‘PIS’) for each site and study can be found below; this is information participants should have received when they signed up for a study. Where applicable, links to updated information provided in line with the General Data Protection Regulation are included as well.

Some research sites recruited participants for more than one study, which involved different stages and numbers of visits. If your site ran more than one study, you can find your information sheet by checking the descriptions of the Work Packages provided below:

WP2.1: This involved approximately 4 visits at 0, 9, 18, and 48 months following recruitment. At each visit, various samples were collected and a liquid ‘meal’ was provided during which regular blood samples were collected to monitor your blood glucose. This study was performed at Kuopio, Amsterdam, Copenhagen and Malmo.

WP2.2 This also involved approximately four visits at 0, 9, 18, and 36 months following recruitment of participants, most of whom were diagnosed as having diabetes. At each visit, various samples were collected and a liquid ‘meal’ was provided during which regular blood samples were collected to monitor your blood glucose. This study was performed at Amsterdam, Copenhagen, Malmo, Newcastle, Exeter and Dundee.

WP3.2 This study looked at intolerance (in the form of gastro-intestinal side effects) in patients taking Metformin to help control their diabetes. It involved one study visit and was conducted at Dundee, Ulm, Exeter, Malmo and Leiden.

WP3.3 This study involved participants with diabetes who were about to take or who were taking a drug called a “GLP-1 Receptor Agonist” such as Exenatide (Byetta and Bydureon), Liraglutide (Victoza, Saxenda), Albiglutide (Tanzeum) or Dulaglutide (Trulicity). It involved either a single visit or several visits (up to five) over a short period of time. It took place at Dundee, Exeter, Newcastle and Oxford.

WP3.5 This involved participants who had diabetes and underwent bariatric surgery. It was only conducted at Lille.

If you are still unsure which WP you were part of, you can contact your site directly to confirm.

Clinical Study Centers

EU General Data Protection Regulation

For more information, and for updates on how the research is progressing please follow us on Twitter: @DIRECTdiabetes and visit our Facebook page: Direct Project.

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This notice supplements the Participant Information Sheet that participants originally received when agreeing to take part in the study and provides further information in light of the new EU General Data Protection Regulation (‘GDPR’).

The Participant Information Sheets can accessed via the links at the top of this page. If you wish to contact the organisation holding your personal data (that is, your ‘study centre’) or their Data Protection Officer, their contact details can be found here.

The legal basis on which your information is used
Under the GDPR, data processing must be necessary for one of a number of specified purposes, that is, for a ‘legal basis.’ If you have questions about the legal basis on which your personal data are processed by your study centre, please contact them directly.

Requesting access to your personal data
The GDPR also gives you the right to access your personal data, although this can be subject to research exemptions which will vary between different countries.

To make a subject access request, please contact your study centre using the information provided above. You can also use these contact details to exercise your right to:

These GDPR rights may also be subject to national exemptions; please contact your study centre if you would like more information.

Complaints
You have the right to lodge a complaint with the data protection authority in your country, but if you have any concerns you can also raise them with the Data Protection Officer of your study centre in case the matter can be resolved.

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Amsterdam (VUmc) / Leiden

WP 2.1 (Dutch)       (Recruited March 2013 to September 2014)
WP 2.2 (Dutch)       (Recruited January 2013 to October 2013)
WP 3.2 (Dutch)       (Leiden, Recruited May 2014 to October 2014)

Contact: Femke Rutters, f.rutters@vumc.nl and Joline Beulens, j.beulens@vumc.nl



NHS Tayside, Ninewells Hospital, Dundee

WP 2.2       (Recruited November 2012 to July 2014)
WP 3.2       (Recruited August 2012 to June 2014)
WP 3.3       (Recruited April 2012 to July 2015 into Group A, B or C)
    WP 3.3—2013 (Group A)—Long Version
    WP 3.3—2013 (Group A)—Short Version
    WP 3.3—2013 (Group B)—Long Version
    WP 3.3—2013 (Group B)—Short Version
    WP 3.3 – 2014 (Group C)

GDPR Update

Contact: Ewan Pearson, E.Z.Pearson@dundee.ac.uk



Exeter

WP 2.2 (English)       (Recruited November 2012 to March 2014)
WP 3.2 (English)       (Recruited May 2012 to June 2014)
WP 3.3                       (Recruited May 2012 to July 2015 into Group A, B or C) – See under Dundee

Contact: Michelle Hudson, M.Hudson@exeter.ac.uk



Københavns

WP 2.1 (Danish)       (Recruited November 2012 to June 2014)
WP 2.2 (Danish)       (Recruited January 2013 – June 2014)
WP 3.1 (Danish)       (Recruited Dec 13)

Contact: Tue Hansen, tuehhansen@sund.ku.dk



Kuopio

WP 2.1 (Finnish)       (Recruited November 2012 to June 2014)
GDPR Updated Privacy Notice 25 April 2018

Contact: Tarja Kokkola, tarja.kokkola@uef.fi



Lille

WP 3.5 (French)       (Recruited November 2012 to June 2014)

Contact: François Pattou, fpattou@univ-lille2.fr



Lund / Malmo

WP 2.1 (Swedish)       (Recruited May 2013 to June 2014)
WP 2.2 (Swedish)       (Recruited November 2012 to June 2014)
WP 3.2 (Swedish)       (Recruited January 2013 to June 2014)

Contact: Paul Franks, paul.franks@med.lu.se



Newcastle

WP 2.2 (English)       (Recruited October 2012 to July 2014)
WP3.3                       (Recruited October 2012 to August 2015 into Group A, B or C) – see Dundee

Contact: Mark Walker, mark.walker@newcastle.ac.uk



Oxford

WP 3.3       (Recruited January 2013 to June 2015 into Group A, B or C) – see Dundee
Group A -- January 2014
Group C -- May 2014

Contact: Nicky McRobert, Nicky.Mcrobert@ouh.nhs.uk