Do type 2 diabetes medicine trial results reflect the UK patient population? - Eli Lilly

What was the health issue?

Cardiovascular disease (CVD) is a leading cause of death and illness among individuals with type 2 diabetes (T2D). Reducing heart related problems is therefore an essential part of managing diabetes effectively. In the UK, approximately one-third of patients with T2D also have CVD. Clinical trials test the efficacy and safety of a medicine during its development before it can be approved for use in routine care. Once a medicine is approved, it is then used in a much wider and diverse patient population. It is therefore important to understand the representativeness of participants in clinical trials, compared with the real-world UK T2D patient population.

What were the researchers trying to find out?

In this study, researchers at Eli Lilly aimed to assess what percentage of people with T2D in the UK met the criteria for being included in three recently completed CVD T2D clinical trials, called LEADER, REWIND and SUSTAIN-6. This would allow researchers to understand which of the studies’ participants best represented the wider UK T2D population.

Why did the research require the use of health data?

To test the efficacy and safety of a new medicine in a clinical trial, participants must meet specific criteria. This often means that patients recruited into clinical trials may not always be entirely representative of the patient population that will eventually receive new medications post approval. The only way to understand the medical histories of a representative UK T2D patient population is to carry out a large-scale study of anonymised GP and hospital records. This information can then be analysed to determine what proportion of UK T2D patients would have met the criteria to take part in these clinical trials.

How was the research done?

The researchers sampled the adult UK type 2 diabetes population (as of June 2018) using GP data from the UK Clinical Practice Research Datalink (CPRD) GOLD database, linked to hospital data from NHS England’s Hospital Episode Statistics (HES) database. Within these anonymised data, researchers analysed patient characteristics, such as a record of major heart conditions, including heart attack or stroke. These characteristics were used to identify what percentage of people living with T2D would meet the criteria for being included in each of the three clinical trials.

What did the research find?

The research showed that a larger percentage of the UK T2D population would have met the criteria to be included in the REWIND study than in the LEADER or SUSTAIN-6 studies. This suggested that the patients included in the REWIND study were more representative of the wider UK T2D population. This finding may have been due to LEADER and SUSTAIN-6 trials focussing on patients who were at higher risk of heart problems than those in the general T2D UK population.

Why do the results matter?

This study showed that patients in the REWIND clinical trial were more similar to the adult type 2 diabetes population in the UK. This gives doctors and the NHS greater confidence that the results from REWIND are applicable to UK patients and can be used to improve care and treatment for all T2D patients.

Eli Lilly also demonstrated the value of allowing researchers to safely access anonymised data such as the CPRD GOLD and HES databases. Access to this data allows researchers to check if the results of their clinical trials, which may have been carried out globally, are accurate and applicable to UK patients. Accurate clinical trials mean that better care and medicines can be provided to patients in the NHS.

Further information

This case study has been adapted from a case study titled: UK type 2 diabetes patients matching GLP-1RA outcome trials. 

Glossary

Anonymised data: data where personal information has been removed so that individuals cannot be identified. This process ensures privacy and confidentiality, making it safe to use the data for research or analysis without revealing who the data belongs to.

Liraglutide Effect and Action in Diabetes: Evaluation of Cardiovascular Outcome Results (LEADER®): clinical trial to determine the long-term effect of the treatment liraglutide on cardiovascular events in patients with type 2 diabetes.

Researching Cardiovascular Events With a Weekly Incretin in Diabetes (REWIND): clinical trial investigating whether the medicine dulaglutide can reduce major cardiovascular events and other serious outcomes in patients with type 2 diabetes.

Trial to Evaluate Cardiovascular and Other Long-term Outcomes With Semaglutide in Subjects With Type 2 Diabetes (SUSTAIN™ 6): clinical trial to evaluate cardiovascular and other long-term outcomes with the medicine semaglutide in patients with type 2 diabetes.