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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

26 participants

Study Classification

INTERVENTIONAL

Study Start Date

2002-06-19

Study Completion Date

2003-10-15

Brief Summary

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

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Detailed Description

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Conditions

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Diabetes Diabetes Mellitus, Type 1

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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IAsp

Group Type EXPERIMENTAL

insulin aspart

Intervention Type DRUG

Injected s.c. (under the skin) three times a day

isophane human insulin

Intervention Type DRUG

May be administered s.c. (under the skin) in both treatment groups thrice daily

HI

Group Type ACTIVE_COMPARATOR

human insulin

Intervention Type DRUG

Injected s.c. (under the skin) 30 minutes before the meals

isophane human insulin

Intervention Type DRUG

May be administered s.c. (under the skin) in both treatment groups thrice daily

Interventions

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insulin aspart

Injected s.c. (under the skin) three times a day

Intervention Type DRUG

human insulin

Injected s.c. (under the skin) 30 minutes before the meals

Intervention Type DRUG

isophane human insulin

May be administered s.c. (under the skin) in both treatment groups thrice daily

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

2 Years

Maximum Eligible Age

6 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No