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.