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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Novo Nordisk A/S
ClinicalTrials.gov Identifier:
NCT00571935
First received: December 11, 2007
Last updated: December 20, 2016
Last verified: December 2016
  Purpose

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.


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

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Efficacy and Safety of Insulin Aspart in MDI or CSII in Children Below 7 Years of Age With Type 1 Diabetes Mellitus

Resource links provided by NLM:


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

Primary Outcome Measures:
  • HbA1c [ Time Frame: after 26 weeks of treatment ]

Secondary Outcome Measures:
  • Overall glycaemic control
  • Occurrence of adverse events
  • Occurrence of serious adverse events
  • Frequency of hypoglycaemia episodes
  • Quality of Life (QoL)

Enrollment: 61
Study Start Date: August 2003
Study Completion Date: October 2004
Primary Completion Date: October 2004 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   up to 7 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
  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: NCT00571935

Locations
Poland
Novo Nordisk Investigational Site
Bialystok, Poland, 15-274
Novo Nordisk Investigational Site
Gliwice, Poland, 44-100
Novo Nordisk Investigational Site
Kielce, Poland, 25-734
Novo Nordisk Investigational Site
Krakow, Poland, 30-663
Novo Nordisk Investigational Site
Warszawa, Poland, 01-184
Sponsors and Collaborators
Novo Nordisk A/S
Investigators
Study Director: Global Clinical Registry (GCR, 1452) Novo Nordisk A/S
  More Information

Additional Information:
Publications:
Responsible Party: Novo Nordisk A/S
ClinicalTrials.gov Identifier: NCT00571935     History of Changes
Other Study ID Numbers: ANA-1507
Study First Received: December 11, 2007
Last Updated: December 20, 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
Insulin
Insulin Aspart
Insulin, Long-Acting
Hypoglycemic Agents
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on April 26, 2017