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.
The details
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.
