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Special Survey for Paediatric Subjects

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01487382
First Posted: December 7, 2011
Last Update Posted: March 4, 2016
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.
Information provided by (Responsible Party):
Novo Nordisk A/S
  Purpose
This study is conducted in Japan. The aim of this study is to collect safety and efficacy data when using NovoRapid® (insulin aspart) in children with type 1 and type 2 diabetes under normal clinical practice conditions.

Condition Intervention
Diabetes Diabetes Mellitus, Type 1 Diabetes Mellitus, Type 2 Drug: insulin aspart

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Special Survey for Paediatric Subjects

Resource links provided by NLM:


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

Primary Outcome Measures:
  • Hypoglycaemic events

Secondary Outcome Measures:
  • HbA1c (glycosylated haemoglobin)
  • Physicial examination
  • Adverse events

Enrollment: 241
Study Start Date: April 2002
Study Completion Date: October 2009
Primary Completion Date: October 2009 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Insulin Aspart Drug: insulin aspart
Injected subcutaneously (s.c., under the skin). Prescribed by physician as a result of normal clinical practice

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   up to 15 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Children under 15 years of age requiring insulin therapy with no treatment history of insulin aspart (NovoRapid®)
Criteria

Inclusion Criteria:

  • Requiring insulin therapy
  • No treatment history of NovoRapid® (insulin aspart)
  Contacts and Locations
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): NCT01487382


Locations
Japan
Tokyo, Japan, 1000005
Sponsors and Collaborators
Novo Nordisk A/S
Investigators
Study Director: Global Clinical Registry (GCR, 1452) Novo Nordisk A/S
  More Information

Additional Information:
Responsible Party: Novo Nordisk A/S
ClinicalTrials.gov Identifier: NCT01487382     History of Changes
Other Study ID Numbers: ANA-1945
First Submitted: November 29, 2011
First Posted: December 7, 2011
Last Update Posted: March 4, 2016
Last Verified: March 2016

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Diabetes Mellitus, Type 1
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Autoimmune Diseases
Immune System Diseases
Insulin
Insulin Aspart
Hypoglycemic Agents
Physiological Effects of Drugs