NN1218-4101 Onset7: Efficacy and Safety of Faster-Acting Insulin Aspart Compared to NovoRapid

Clinical Trial

Offered by: Nemours Children's Specialty Care, Jacksonville
Location: Jacksonville, Fla.

Trial Name

NN1218-4101 Onset®7: Efficacy and Safety of Faster-Acting Insulin Aspart Compared to NovoRapid®

What is the trial about?

The purpose of this study is to compare the blood sugar lowering effect and the safety of faster-acting insulin aspart with insulin aspart: (Novolog), in combination with a long acting basal insulin degludec (Tresiba).

Who can participate?

Children between the ages of 2–18 years of age who have been diagnosed with Type 1 Diabetes and have been on injectable insulin for 90 days or greater may be eligible for this study. The child's A1C must be under 9.5 percent.

What is involved?

Involvement in the trial will last approximately 45 weeks. During this time you and your child will have a weekly contact (either a physical visit or a phone call.) In total, you and your child will have 17 clinic visits and 25 telephone contacts. 

Five blood draws and five physical exams will be done during the course of the 45 week trial. Subjects over the age of eight may also choose to be in a sub-study which includes wearing a blinded continuous glucose monitor two times over the course of the 45 week trial. The sub-study subjects will have a meal test done at the hospital. Subjects will drink a liquid meal, inject insulin and then have blood drawn over a four hour period.

Contact Nemours Clinical Trials

Trial Name: NN1218-4101 Onset®7: Efficacy and Safety of Faster-Acting Insulin Aspart Compared to NovoRapid® 

Contact Information

(800) 354-5690
ClinicalTrials@nemours.org