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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:
Novo Nordisk
ClinicalTrials.gov Identifier:
NCT00571935
First received: December 11, 2007
Last updated: June 5, 2012
Last verified: September 2011
History of Changes
  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
Endpoint Classification: Safety/Efficacy Study
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:

U.S. FDA Resources

Further study details as provided by Novo Nordisk:

Primary Outcome Measures:
  • HbA1c [ Time Frame: after 26 weeks of treatment ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Overall glycaemic control [ Designated as safety issue: No ]
  • Occurrence of adverse events [ Designated as safety issue: No ]
  • Occurrence of serious adverse events [ Designated as safety issue: No ]
  • Frequency of hypoglycaemia episodes [ Designated as safety issue: No ]
  • Quality of Life (QoL) [ Designated as safety issue: No ]

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
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00571935

Locations
Poland
Warszawa, Poland, 01-184
Sponsors and Collaborators
Novo Nordisk
Investigators
Study Director: Maciej Nazar, MD, PhD Novo Nordisk Pharma Sp.z.o.o
  More Information

Additional Information:
Clinical Trials at Novo Nordisk  This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party: Public Access to Clinical Trials, 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: June 5, 2012
Health Authority: Poland: The Office for Registration of Medicinal Products, Medical Devices; and Biocides, Central Evidence of Clinical Trials

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 1
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Autoimmune Diseases
 Immune System Diseases
Insulin aspart
Insulin
Hypoglycemic Agents
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 21, 2013