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

Novo Nordisk

Status and phase: Completed; Phase 4

Conditions: Diabetes Mellitus, Type 1; Diabetes

Treatments: Drug: isophane human insulin; Drug: insulin aspart; Drug: human insulin

Study type: Interventional

Funder types: Industry

Identifiers

NCT01467141

ANA-1415

Details and patient eligibility

About

This trial is conducted in Europe. The aim of this trial is to evaluate safety and efficacy in children with type 1 diabetes.

Enrollment: 26 patients

Sex: All

Ages: 2 to 6 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Type 1 diabetes
• Treatment with insulin for at least 6 months prior to inclusion
• HbA1c below or equal to 11.0 %
• Currently treated with short acting, intermediate acting, long acting human insulin or analogues or a self-mix of these insulins at least 1 month prior to inclusion

Exclusion criteria

• The receipt of any investigational drug within one month prior to this trial
• Recurrent severe hypoglycaemia or hypoglycaemic awareness as judged by the investigator
• Total daily insulin doses at least 1.80 IU/kg
• Treatment with oral hypoglycaemic agents
• Known or suspected allergy to trial product or related products

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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26 participants in 2 patient groups

IAsp

Experimental group

Treatment:

Drug: insulin aspart

Drug: isophane human insulin

HI

Active Comparator group

Treatment:

Drug: human insulin

Drug: isophane human insulin