This phase 3 clinical trial is investigating the safety and effectiveness of dapagliflozin (Forxiga) and saxagliptin (Onglyza) in young people with type 2 diabetes (T2D). The main outcome to be measured will be change in HbA1c (measures average blood glucose over the last 3 months) after 6 months of treatment.
Dapagliflozin increases the removal of glucose from the body in the urine. Saxagliptin helps to stimulate the release of insulin (hormone that lowers blood glucose) and inhibit the release of glucagon (hormone that raises blood glucose). Dapagliflozin and saxagliptin are approved for people with T2D aged 18 or older. However, there is limited data on their use in children and adolescents.
The main outcome will be measured as the change in HbA1c after 6 months of treatment.
Who are they looking for?
This trial is looking for 243 children and adolescents with T2D, who are have been receiving insulin, metformin (Glucophage), or both for at least 8 weeks. Their HbA1c level must be between 6.5% and 10.5% at the start of the study.
Participants may not be using anti-diabetes drugs other than insulin or metformin. They also may not have used prescription weight loss drugs in the last 8 weeks, or corticosteroid drugs in the last 3 months. They may not have severe kidney disease, cancer, liver disease, anemia, psychiatric disease, or a history of drug or alcohol addiction. They may not have had diabetic ketoacidosis (life-threatening emergency) in the last 6 months. They may not have participated in another clinical trial in the last 3 months. Female participants must not become pregnant or breastfeed during the study.
How will it work
The participants will be divided, randomly, into three groups. Group 1 will receive dapagliflozin once daily. Group 2 will receive saxagliptin once daily. Group 3 will receive a placebo (drug with no active effect) tablet daily. They will all continue their insulin and/or metformin treatment as normal. After 12 weeks HbA1c will be tested. Those with HbA1c greater than 7% will receive the same treatment if they are in group 3. If they are in groups 1 or 2 they will either continue as before, or receive a higher dose. The participants will be followed for up to 2 years.
HbA1c and fasting blood glucose (blood glucose after a period without food or drink) will be measured at the start, after 6 months, and after 1 year. It will be noted if participants need other medications to control blood glucose levels during the first 6 months of treatment. Any side effects will be noted after 56 weeks of treatment. After 2 years, participants will be examined for growth and pubertal development.