Evaluating if type 2 diabetes medication trial results apply to real-world UK patient populations - Eli Lilly

Patients

December 2024

Summary

UK T2D patients matching GLP-1RA outcome trials

This was a study, conducted by Eli Lilly, looking at cardiovascular complications in patients receiving treatment for type 2 diabetes (T2D). 

Lilly

About this study

Minimising cardiovascular problems is an essential part of managing diabetes effectively, because cardiovascular disease (CVD) is a leading cause of death and illness among individuals with T2D. This study examined the results from three clinical trials, for treatments used in the management of diabetes.

The purpose of this study was to assess how well the patient populations in the three clinical trials represented the real-world UK T2D population.

The study leads sampled the adult UK T2D population (as of June 2018) through the UK Clinical Practice Research Datalink GOLD database and subsequently identified T2D patients with recorded major cardiovascular events via Hospital Episode Statistics data.

The studied show that REWIND contained a greater proportion of patients reflective of the UK T2D population compared to both LEADER and SUSTAIN-6.

Importantly, REWIND also captured a broader spectrum of patient whereas LEADER and SUSTAIN-6 focussed more narrowly on patients who were at higher risk of CVD. Therefore, REWIND demonstrates a better representation of the real-world UK T2D population.

Data sources used:

• Hospital Episode Statistics (HES): includes details on patient hospital admissions, outpatient appointments, and accident and emergency attendances at NHS hospitals in England.

• UK Clinical Practice Research Datalink GOLD database: a comprehensive UK database containing anonymised electronic health records from over 21 million patients, capturing demographic information, diagnoses, drug exposures, and other medical data.

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

• 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 subjects 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 treatment semaglutide in subjects with type 2 diabetes.

Benefits of the study

This study has provided greater understanding of the role that diabetes treatments play in reducing risk of cardiovascular events in T2D patients in the UK. It establishes that the REWIND trial aligned most closely with the UK adult T2D population, allowing the NHS to use the findings to better optimise the management of T2D patients.

By accessing patient data to retrospectively analyse three clinical trials, the study demonstrates the value of allowing researchers to safely access anonymised patient data. Without public and industry access to datasets such as UK Clinical Practice Research Datalink GOLD and Hospital Episodes Statistics, such validatory studies cannot be conducted routinely for the benefit of patients and the NHS.

Further information

Read the clinical study

Glossary

Anonymised patient data: data that has personal information and details removed. Whilst the individual cannot be identified, information is still available on patient demographics, medical history treatments and survival information.

Real-world population: whether data collected during a clinical trial is representative of and applicable to the wider UK population, not just the small number assessed in a trial setting. 

Major cardiovascular events: serious heart-related problems including heart attacks and strokes. 

Last modified: 15 February 2025

Last reviewed: 15 February 2025