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

This study has been completed.
Sponsor:
Information provided by:
Novo Nordisk
ClinicalTrials.gov Identifier:
NCT01467141
First received: November 4, 2011
Last updated: January 25, 2012
Last verified: January 2012
History of Changes

November 4, 2011
January 25, 2012
June 2002
October 2003   (final data collection date for primary outcome measure)
  • Incidence of hypoglycaemic episodes during the treatment [ Designated as safety issue: No ]
  • Change in HbA1c (glycosylated haemoglobin A1c) [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01467141 on ClinicalTrials.gov Archive Site
Incidence of Adverse Events (AEs) [ Designated as safety issue: No ]
Same as current
 
 
 
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

This trial is conducted in Europe. The aim of this trial is to evaluate safety and efficacy in children with type 1 diabetes.
 
Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Diabetes
  • Diabetes Mellitus, Type 1
  • Drug: insulin aspart
    Injected s.c. (under the skin) three times a day
  • Drug: human insulin
    Injected s.c. (under the skin) 30 minutes before the meals
  • Drug: isophane human insulin
    May be administered s.c. (under the skin) in both treatment groups thrice daily
  • Experimental: IAsp
    Interventions:
    • Drug: insulin aspart
    • Drug: isophane human insulin
  • Active Comparator: HI
    Interventions:
    • Drug: human insulin
    • Drug: isophane human insulin
 

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
26
October 2003
October 2003   (final data collection date for primary outcome measure)

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
Both
2 Years to 6 Years
No
Contact information is only displayed when the study is recruiting subjects
Germany
 
NCT01467141
ANA-1415
No
Public Access to Clinical Trials, Novo Nordisk A/S
Novo Nordisk
 
Study Director: Vibeke Weinreich Novo Nordisk
Novo Nordisk
January 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP