NCT01467141|CompletedPhase 4

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

Meal-related Insulin Aspart Therapy Versus Meal-related Human Insulin Therapy in Children 2-6 Years of Age With Type 1 Diabetes Mellitus: A Multi-centre Randomised, Open-labelled, Cross-over, Safety and Efficacy Trial

Novo Nordisk A/S ClinicalTrials.gov

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1 other identifier

ANA-1415

Study Type

interventional

Target

Locations

1 country

Sites

Timeline

RegisteredNov 2011

StartedJun 2002

CompletionOct 2003

Brief Summary

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

Trial Health

On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment

participants targeted

Target at below P25 for phase_4 diabetes

Timeline

Completed

Started Jun 2002

Geographic Reach

1 country

6 active sites

Status

completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

1.3 years study duration

Study Start

First participant enrolled

June 19, 2002

Completed

1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 15, 2003

Completed

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 15, 2003

Completed

8.1 years until next milestone

First Submitted

Initial submission to the registry

November 4, 2011

Completed

4 days until next milestone

First Posted

Study publicly available on registry

November 8, 2011

Completed

Last Updated

February 23, 2017

Status Verified

February 1, 2017

Enrollment Period

1.3 years

First QC Date

November 4, 2011

Last Update Submit

February 22, 2017

Conditions

Diabetes Diabetes Mellitus, Type 1

Outcome Measures

Primary Outcomes (2)

Incidence of hypoglycaemic episodes during the treatment
Week 0; week 24
Change in HbA1c (glycosylated haemoglobin A1c)
Week 0; week 24

Secondary Outcomes (1)

Incidence of Adverse Events (AEs)
Week 0; week 24

Study Arms (2)

IAsp

EXPERIMENTAL

Drug: insulin aspartDrug: isophane human insulin

HI

ACTIVE COMPARATOR

Drug: human insulinDrug: isophane human insulin

Interventions

insulin aspartDRUG

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

IAsp

human insulinDRUG

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

isophane human insulinDRUG

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

HIIAsp

Eligibility Criteria

Age2 Years - 6 Years

Sexall

Healthy VolunteersNo

Age GroupsChild (0-17)

You may qualify if:

Type 1 diabetes
HbA1c below or equal to 11.0 %

You may not qualify if:

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

Contact the study team to confirm eligibility.