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Special Survey for Paediatric Subjects

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ClinicalTrials.gov Identifier: NCT01487382
Recruitment Status : Completed
First Posted : December 7, 2011
Last Update Posted : March 4, 2016
Sponsor:
Information provided by (Responsible Party):
Novo Nordisk A/S

Brief Summary:
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 or disease Intervention/treatment
Diabetes Diabetes Mellitus, Type 1 Diabetes Mellitus, Type 2 Drug: insulin aspart

Study Type : Observational
Actual Enrollment : 241 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Special Survey for Paediatric Subjects
Study Start Date : April 2002
Actual Primary Completion Date : October 2009
Actual Study Completion Date : October 2009

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
Insulin Aspart Drug: insulin aspart
Injected subcutaneously (s.c., under the skin). Prescribed by physician as a result of normal clinical practice




Primary Outcome Measures :
  1. Hypoglycaemic events

Secondary Outcome Measures :
  1. HbA1c (glycosylated haemoglobin)
  2. Physicial examination
  3. Adverse events


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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)

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

Additional Information:
Responsible Party: Novo Nordisk A/S
ClinicalTrials.gov Identifier: NCT01487382     History of Changes
Other Study ID Numbers: ANA-1945
First Posted: December 7, 2011    Key Record Dates
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