This trial is examining the effectiveness of tirzepatidecompared to insulin glargine in patients with type 2 diabetes who are also at high risk for heart disease. The main outcome to be measured will be a change in HbA1c (a blood test that measures average blood sugar levels in the past 3 months) over 52 weeks.
In type 2 diabetes (T2D), patients do not make enough insulin (a hormone that controls blood sugar). This causes blood sugars to rise. Therefore, insulin replacement is eventually recommended. However, there are some dangerous side effects of insulin such as hypoglycaemia (blood sugar going dangerously low). Therefore, insulin treatment is kept for when all other therapies fail. Tirzepatide is a drug that causes the body to release more of its own natural insulin. It is in a group of drugs called GLP-1 agonist.
Patients with T2D are at risk of developing heart disease. Some other GLP-1 agonists have shown to have beneficial effects on the heart.
This study aims to investigate how effective tirzepatide is in the treatment of T2D in patients who are also at high risk of heart disease compared to treatment with insulin glargine (Lantus). The main outcome to be measured will be a change in HbA1c following treatment.
Who are they looking for?
This trial is recruiting 1878 participants. Patients must have a HbA1c less than 10.5% and also be at increased risk for heart disease. Patients' weight must be stable.
Patients must not have any disorders associated with delayed emptying of the stomach, hepatitis or any other liver disease. Patients may have non-alcoholic fatty liver disease but their liver function tests must be less than 3 times the upper limit of normal for the reference range. Patients must not have had a stroke or heart attack or been hospitalized for heart failure in the past 2 months. Patients must not have a personal or family history of medullary thyroid cancer or have a personal history of multiple endocrine neoplasia syndrome type 2. Patients must not have been taking weight loss drugs, including over-the-counter medications in the past 3 months.
How will it work
Patients will be randomly assigned to one of 4 groups. Group 1 will receive a 5mg terzepatide weekly injection. Group 2 will receive a 10mg terzepatide weekly injection. Group 3 will receive a 15mg terzepatide weekly injection and group 4 will receive insulin glargine injections daily. Patients will be treated for 52 weeks. However, the study will last approximately 108 weeks and may involve up to 30 visits.
The change in HbA1c will be measured by blood tests at the start and after 52 weeks of treatment. Other outcomes to be measured will be changes in body weight, fasting blood sugar levels and rates of hypoglycemia.