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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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00571935
Recruitment Status : Completed
First Posted : December 12, 2007
Last Update Posted : December 21, 2016
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Diabetes Diabetes Mellitus, Type 1 Drug: insulin aspart Drug: soluble human insulin Phase 4

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 61 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (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
Study Start Date : August 2003
Primary Completion Date : October 2004
Study Completion Date : October 2004

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Diabetes Type 1
U.S. FDA Resources

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

Secondary Outcome Measures :
  1. Overall glycaemic control
  2. Occurrence of adverse events
  3. Occurrence of serious adverse events
  4. Frequency of hypoglycaemia episodes
  5. Quality of Life (QoL)

Information from the National Library of Medicine

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

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00571935

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
Study Director: Global Clinical Registry (GCR, 1452) Novo Nordisk A/S

Additional Information:
Responsible Party: Novo Nordisk A/S
ClinicalTrials.gov Identifier: NCT00571935     History of Changes
Other Study ID Numbers: ANA-1507
First Posted: December 12, 2007    Key Record Dates
Last Update Posted: December 21, 2016
Last Verified: December 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 Aspart
Insulin, Long-Acting
Hypoglycemic Agents
Physiological Effects of Drugs