ASCEND PLUS case study

Diabetes is a major global health issue:

• more than 400 million people live with diabetes around the world
• 1 in 10 people will have diabetes by 2035
• people with diabetes are more likely to develop heart and circulatory problems

ASCEND PLUS is a randomised controlled trial. The trial team is working with NHS DigiTrials to recruit 20,000 people aged 55 years and older, who have type 2 diabetes and have not previously suffered a heart attack or stroke, to take part in a national clinical trial across England.

Eligible participants are asked to take a daily tablet containing either semaglutide or an inactive placebo (a tablet that looks like semaglutide but has no active drug) for about 5 years. The goal of the trial is to test whether taking oral semaglutide daily can help protect people with type 2 diabetes from suffering heart attacks, strokes and other complications of diabetes.

NHS DigiTrials used de-identified NHS data to confirm the viability of the ASCEND PLUS trial. Once the feasibility of the trial was established, NHS data was used to invite eligible participants on the trial's behalf. 

This approach is expected to significantly accelerate the recruitment process, with the trial on track to enrol 20,000 participants in just over 2 years. This is in comparison to the 6 years it took from 2005 to recruit 15,480 participants for the original ASCEND trial (to test aspirin and/or omega-3 fatty acids) without NHS DigiTrials.

NHS DigiTrials is also enabling ASCEND PLUS to run a decentralised trial as the 20,000 participants conveniently track their progress by completing questionnaires online or via phone interviews, eliminating the need to travel to a research clinic for their study assessments. This helps remove the barriers that may previously have deterred individuals from taking part in clinical trials.

Benefits to patients include:

1. Protecting at risk groups. People with diabetes are especially vulnerable as this condition roughly doubles the risk of developing cardiovascular disease. 
2. Improving treatment for people with type 2 diabetes. If successful, results from this trial will help more people to live well with the condition.

The study is funded by the Danish healthcare company, Novo Nordisk. It began in 2023 and it is expected participants will take part for an average of about 5 years.

As it becomes easier to decentralise trials and use NHS data to recruit eligible people through NHS DigiTrials, we are improving the diversity of participants and the validity of the research.

By reducing recruitment time from six years to just two and enabling 20,000 participants to engage from home, ASCEND PLUS is accelerating preventative treatments to protect over 400 million people globally people with type 2 diabetes.

This demonstrates the power of bringing together NHS data and life sciences to save people’s lives.