The main objective of this trial is to determine the safety and efficacy of dapagliflozin (Farxiga) in type 2 diabetes patients aged 10-24 years. The main outcome to be measured is the change in average blood glucose (sugar) levels.
The details
Dapagliflozin is a type 2 diabetes treatment that removes glucose from the blood and increases the amount of glucose secreted in the urine. Dapagliflozin is currently used as a treatment for adults with type 2 diabetes.
The aim of this trial is to determine whether dapagliflozin is safe and effective when used in type 2 diabetes patients aged between 10 and 24 years. The main outcome to be measured is the change in blood gluocose levels after 24 weeks of treatment.
Who are they looking for?
This study will recruit 54 patients who are between the age of 10 and 24 years and who have been diagnosed with type 2 diabetes for at least 2 months. Participants must have an HbA1c level (average blood glucose over 3 months) between 6.5% and 11%. Patients who are currently on a diet and are taking a stable dose of metformin (Glucophage - used to treat high blood sugar levels) and/or insulin for at least 8 weeks prior to screening will be considered eligible.
Patients who have previously been diagnosed with type 1 diabetes or diabetes ketoacidosis (a condition that occurs when the cells of the body do not get enough glucose for energy and they begin to burn fat, producing acidic products that can result in a coma) will not be eligible. Patients who have kidney or bladder problems, blood deficiencies, or blood in the urine will not be considered. Patients treated with prescription weight loss drugs or other medications for the treatment of diabetes, including dapagliflozin, are not eligible. Patients with abnormal blood or hormone readings will not be eligible. Patients who are currently trying to get pregnant or are currently pregnant will not be considered eligible.
How will it work
Patients will be split in to two groups. Group 1 will receive 10 mg of dapagliflozin orally once daily for 24 weeks, followed by a possible 28 week extension.
Group 2 will undergo the same treatment as group 1 but will receive a placebo (substance with no effect on the body) instead of the active drug.
HbA1c levels will be measured at the start of the study and after 24 weeks.
