Efficacy and Safety of Insulin Aspart in MDI or CSII in Children Below 7 Years of Age With Type 1 Diabetes

Novo Nordisk

Status and phase: Completed; Phase 4

Conditions: Diabetes Mellitus, Type 1; Diabetes

Treatments: Drug: soluble human insulin; Drug: insulin aspart

Study type: Interventional

Funder types: Industry

Identifiers

NCT00571935

ANA-1507

Details and patient eligibility

About

This trial is conducted in Europe.

The aim of this trial is to investigate the efficacy of insulin aspart compared to soluble human insulin on blood glucose control in children below 7 years of age with type 1 diabetes.

Enrollment: 61 patients

Sex: All

Ages: Under 7 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Type 1 diabetes for at least 1 year
• HbA1c below 12.0%
• Treatment with regular human insulin and insulin NPH for at least 1 month
• Receive more than 2 injections daily

Exclusion criteria

• Receipt of investigational product within 6 months prior to trial participation
• Known or suspected allergy to investigational product
• Receipt of of insulin aspart within 3 months prior to trial participation

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)