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

Diabetes Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00571935
• Other study ID #: ANA-1507
• Status: Completed
• Phase: Phase 4
• First received: December 11, 2007
• Last updated: December 20, 2016
• Start date: August 2003
• Est. completion date: October 2004

Study information

• Verified date: December 2016
• Source: Novo Nordisk A/S
• Contact: n/a
• Is FDA regulated: No
• Health authority: Poland: The Office for Registration of Medicinal Products, Medical Devices; and Biocides, Central Evidence of Clinical Trials
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 61
• Est. completion date: October 2004
• Est. primary completion date: October 2004
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A to 7 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Diabetes
• Diabetes Mellitus
• Diabetes Mellitus, Type 1

Intervention

Drug:
• insulin aspart

• soluble human insulin

Locations

Country	Name	City	State
Poland	Novo Nordisk Investigational Site	Bialystok
Poland	Novo Nordisk Investigational Site	Gliwice
Poland	Novo Nordisk Investigational Site	Kielce
Poland	Novo Nordisk Investigational Site	Krakow
Poland	Novo Nordisk Investigational Site	Warszawa

Sponsors (1)

Lead Sponsor	Collaborator
Novo Nordisk A/S

Country where clinical trial is conducted

Poland, 

References & Publications (1)

Pankowska E, Nazim J, Szalecki M, Urban M. Equal metabolic control but superior caregiver treatment satisfaction with insulin aspart in preschool children. Diabetes Technol Ther. 2010 May;12(5):413-8. doi: 10.1089/dia.2009.0155. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	HbA1c		after 26 weeks of treatment	No
Secondary	Overall glycaemic control			No
Secondary	Occurrence of adverse events			No
Secondary	Occurrence of serious adverse events			No
Secondary	Frequency of hypoglycaemia episodes			No
Secondary	Quality of Life (QoL)			No

External Links

•   Clinical Trials at Novo Nordisk