About the SURPASS-CVOT trial
We are looking for volunteers to join the SURPASS-CVOT study. This leaflet is a short summary of the trial and what participation involves. We hope this information will help you and your family decide if this clinical trial is right for you.
What is the purpose of the study?
People with type 2 diabetes mellitus (T2DM) are much more likely to have disease of the heart and blood vessels (cardiovascular disease) than adults without diabetes. This is why all new drugs for T2DM need to be studied in people who already have cardiovascular disease, to understand their effect on this. The SURPASS-CVOT clinical research trial will test how effective the investigational study medication tirzepatide is when compared to dulaglutide (an approved diabetes medication) at reducing major adverse cardiovascular events (like heart attacks and strokes) in people with T2DM and a history of cardiovascular disease. An investigational medication is one which is being studied in clinical trials and is not yet available on prescription.
How large is the study and how long will it last?
This is an international study which aims to enrol 12,500 volunteers. It is expected that around 200 of these will be from the UK. It will last for up to five or six years.
Who can join the study?
We are looking for volunteers who:
- Have type 2 diabetes
- Are 40 years of age or older
- Who have a history of cardiovascular disease
- Who are overweight or obese
Volunteers who decide to take part will be given a health check to confirm eligibility for the study and that they and the study are right for each other. This part of the study is called screening.
What are the benefits of joining the study?
- Study participants will have the benefit of regular health checks
- Both drugs used in the study have the potential to improve diabetes control
- Both drugs used in the study have the potential to help with weight loss
- The study results may help to improve health care for people with T2DM in future
What medication will volunteers take during the study?
Volunteers who are eligible and agree to take part will be asked to take an additional diabetes medication during the study for up to 5-6 years. They will be assigned to take either the investigational study medication (tirzepatide), or dulaglutide. This will be done randomly (by chance) and neither the participant nor the study staff will know which group they have been placed in.
Participants will receive their study treatment via a subcutaneous (under the skin) injection once a week. The study team will show participants how to self-inject. The dose of study drug will be increased every 4 weeks during the first 6 months of the study (this is called the Dose Escalation Period of the study) until the target dose is reached, dependant on the participant’s response to the study drug. Increasing the dose in this way is intended to help the body get used to the medication and to reduce side effects. If the target dose is not achieved by the end of the dose escalation period, there will be a further opportunity to reach the target dose during the next part of the study (the Maintenance Period) which will last approximately 48 months.
How many appointments will there be and what will they involve?
There will be 1 screening appointment. Participants’ health will be then monitored by visits to the study centre every four weeks for the first six months (the Dose Escalation Period) and every three months thereafter (during the Maintenance Period) The total number of visits to the study centre will be around 30, plus the option of 6 additional telephone appointments. Visits will include assessments such as:
- Blood samples
- Urine samples
- Blood pressure and pulse rate measurements
- Weight and waist measurements
- ECG (heart tracing)
- Eye examination
- Changes to health and medication
It is very important that participants attend all their appointments, as the data we gather will help us decide the future of the investigational medication.
How to I take part?
If you are interested in the possibility of taking part in this research trial, please contact the study staff (details below). We will be happy to provide further information, answer any questions you may have and discuss the study with you. You will not be pressurised to join the study. No one has to take part if they don’t want to, and their decision will not affect the usual healthcare to which they are entitled.
Study staff contact details: Leicester Diabetes Centre
Principal Investigator : Professor Melanie Davies
Study Coordinators: Penny Donley/Jane Brela
Telephone: 0116 258 4725/0116 258 4499 (answerphone)
Email:firstname.lastname@example.org or email@example.com