Efficacy and Safety of Faster-Acting Insulin Aspart in Children With Type 1 Diabetes

Trial Name

Efficacy and Safety of Faster-Acting Insulin Aspart in Children With Type 1 Diabetes

What is the trial about?

We would like to compare the blood sugar lowering effect and safety of a newer, faster-acting insulin to that of an available insulin to treat children and adolescents with Type 1 Diabetes.

Who can participate?

Children ages 1 through 17 with Type 1 Diabetes Mellitus who are receiving ongoing daily treatment with a basal-bolus insulin regimen and whose hemoglobin A1c results are 9.5 percent or less are eligible for participation in this study.

What is involved?

Your child will receive either a short acting insulin or an investigational faster-acting insulin, both in combination with an investigational basal insulin. Your child’s involvement in the study will last approximately 45 weeks. During this time, you and your child will have weekly contact with the study site, either by visit or phone call. In total, you and your child will have 17 visits and 25 telephone contacts to the study site.

At 5 of the 17 site visits, there will be a blood draw done. These samples are taken to test for kidney and liver function, blood count and hemoglobin A1c.