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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Novo Nordisk A/S
ClinicalTrials.gov Identifier:
NCT01467141
First received: November 4, 2011
Last updated: December 19, 2016
Last verified: December 2016
  Purpose
This trial is conducted in Europe. The aim of this trial is to evaluate safety and efficacy in children with type 1 diabetes.

Condition Intervention Phase
Diabetes
Diabetes Mellitus, Type 1
Drug: insulin aspart
Drug: human insulin
Drug: isophane human insulin
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:


Further study details as provided by Novo Nordisk A/S:

Primary Outcome Measures:
  • Incidence of hypoglycaemic episodes during the treatment [ Time Frame: Week 0; week 24 ]
  • Change in HbA1c (glycosylated haemoglobin A1c) [ Time Frame: Week 0; week 24 ]

Secondary Outcome Measures:
  • Incidence of Adverse Events (AEs) [ Time Frame: Week 0; week 24 ]

Enrollment: 26
Study Start Date: June 2002
Study Completion Date: October 2003
Primary Completion Date: October 2003 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: IAsp Drug: insulin aspart
Injected s.c. (under the skin) three times a day
Drug: isophane human insulin
May be administered s.c. (under the skin) in both treatment groups thrice daily
Active Comparator: HI 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

  Eligibility

Ages Eligible for Study:   2 Years to 6 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01467141

Locations
Germany
Novo Nordisk Investigational Site
Berlin, Germany, 13353
Novo Nordisk Investigational Site
Dresden, Germany, 01307
Novo Nordisk Investigational Site
Hagen, Germany, 58095
Novo Nordisk Investigational Site
Hamburg, Germany, 22149
Novo Nordisk Investigational Site
Hannover, Germany, 30173
Novo Nordisk Investigational Site
Osnabrück, Germany, 49082
Sponsors and Collaborators
Novo Nordisk A/S
Investigators
Study Director: Vibeke Weinreich Novo Nordisk A/S
  More Information

Additional Information:
Publications:
Responsible Party: Novo Nordisk A/S
ClinicalTrials.gov Identifier: NCT01467141     History of Changes
Other Study ID Numbers: ANA-1415 
Study First Received: November 4, 2011
Last Updated: December 19, 2016

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 1
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Autoimmune Diseases
Immune System Diseases
Insulin, Globin Zinc
Insulin degludec, insulin aspart drug combination
Isophane insulin, beef
Insulin
Insulin Aspart
Insulin, Long-Acting
Isophane Insulin, Human
Insulin, Isophane
Hypoglycemic Agents
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on January 19, 2017