Insulin Aspart vs. Insulin Lispro vs. Regular Insulin in Paediatric Population

Novo Nordisk

Status and phase: Completed; Phase 3

Conditions: Diabetes Mellitus, Type 1; Diabetes

Treatments: Drug: insulin aspart; Drug: insulin lispro; Drug: insulin human

Study type: Interventional

Funder types: Industry

Identifiers

NCT00071448

ANA-2126

Details and patient eligibility

About

This trial is conducted in the United States of America (USA). The aim of this trial is to to determine whether insulin aspart can be used effectively and safely in paediatric patients.

Enrollment: 378 patients

Sex: All

Ages: 6 to 18 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria:

• Pediatric patients with Type 1 diabetes for at least one year
• HbA1c less than 12%
• Willing to administer at least 3 injections per day
• Willing to perform self monitored blood glucose (SMBG) at least 4 times per day, includes subject and/or parent/guardian, as necessary

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)