This phase 3 trial aims to evaluate the safety and effectiveness of alogliptin (Nesina) in pediatric patients with type 2 diabetes.
The main outcome to be investigated is the effect on blood glucose control after 26 weeks of treatment.
Managing blood glucose levels is key in the treatment of type 2 diabetes. Standard treatment for type 2 diabetes in pediatric patients includes insulin and/or metformin (Glucophage) . These medications may help reduce blood glucose but in some cases, additional medication is needed to achieve adequate blood glucose control.
Alogliptin is a new drug that reduces blood sugar by blocking an enzyme called dipeptidyl peptidase-4 (DPP4). This study will determine if monotherapy (alogliptin alone) or co-administration with insulin or metformin reduces blood glucose levels.
Who are they looking for?
This study will recruit approximately 200 patients (aged 10-17 years) with type 2 diabetes. Patients should be able to swallow a tablet containing the study medication. Patients must be willing to monitor their blood glucose levels with or without the help of a parent or legal guardian.
Patients cannot take part in the trial if they have a history of sensitivity to alogpitin, other DPP4 inhibitors, metformin or insulin. Other exclusion criteria include: type 1 or mature onset diabetes, a history of bariatric (gastric bypass) surgery, pancreatitis and HIV or chronic active viral infections.
How will it work
Patients will be randomly assigned to 2 groups. One group will receive alogliptin (25 mg, oral once daily) in addition to the patient’s standard anti-diabetic therapy (metformin or insulin). The other group will receive placebo (substance with no active effect) and standard anti-diabetic therapy (metformin or insulin). The study will last for 52 weeks.
HbA1c levels will be measured at 12, 18, 26, 39, and 52 weeks.