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Special Survey of Production of Insulin Aspart Specific Antibody

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: NCT01487369
Recruitment Status : Completed
First Posted : December 7, 2011
Last Update Posted : March 4, 2016
Sponsor:
Information provided by (Responsible Party):

Study Description
Brief Summary:
This study is conducted in Japan. The aim of this study is to collect data of production of insulin aspart specific antibody under normal clinical practice conditions.

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

Study Design

Study Type : Observational
Actual Enrollment : 204 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Special Survey of Production of Insulin Aspart (IAsp) Specific Antibody
Study Start Date : April 2002
Primary Completion Date : October 2009
Study Completion Date : October 2009

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Groups and Cohorts

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.


Outcome Measures

Primary Outcome Measures :
  1. Antibody titre findings

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

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients with diabetes requiring insulin therapy and who had a treatment history of NovoRapid® (insulin aspart)
Criteria

Inclusion Criteria:

  • Patients with diabetes requiring insulin therapy

Exclusion Criteria:

  • Patients who had a 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): NCT01487369


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: NCT01487369     History of Changes
Other Study ID Numbers: ANA-1946
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, Globin Zinc
Insulin degludec, insulin aspart drug combination
Insulin
Insulin Aspart
Insulin, Long-Acting
Antibodies
Hypoglycemic Agents
Physiological Effects of Drugs
Immunologic Factors