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

Phase 4

Completed

• Conditions: Diabetes Mellitus, Type 1; Diabetes

• Registration Number: NCT00571935
• Lead Sponsor: Novo Nordisk A/S

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2003-08
• Primary Completion: 2004-10
• Study Completion: 2004-10
• Study First Submitted: 2007-12-11
• Study First Submitted QC: 2007-12-11
• Study First Posted: 2007-12-12
• Status Verified: 2016-12
• Last Update Submitted: 2016-12-20
• Last Update Posted: 2016-12-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 61

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
HbA1c	after 26 weeks of treatment

Secondary Outcome Measures

Name	Time	Method
Overall glycaemic control
Occurrence of adverse events
Occurrence of serious adverse events
Frequency of hypoglycaemia episodes
Quality of Life (QoL)

Trial Locations

Locations (1)

Novo Nordisk Investigational Site; 🇵🇱 Warszawa, Poland