Special Survey of Production of Insulin Aspart Specific Antibody

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Novo Nordisk A/S
ClinicalTrials.gov Identifier:
NCT01487369
First received: November 29, 2011
Last updated: December 7, 2011
Last verified: December 2011
  Purpose

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 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 of Production of Insulin Aspart (IAsp) Specific Antibody

Resource links provided by NLM:


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

Primary Outcome Measures:
  • Antibody titre findings [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Hypoglycemic events [ Designated as safety issue: No ]
  • Adverse events [ Designated as safety issue: No ]
  • HbA1c (glycosylated haemoglobin) [ Designated as safety issue: No ]

Enrollment: 204
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

Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01487369

Locations
Japan
Tokyo, Japan, 103
Sponsors and Collaborators
Novo Nordisk A/S
Investigators
Study Director: Masayuki Senda Novo Nordisk Pharma Ltd.
  More Information

Additional Information:
No publications provided

Responsible Party: Novo Nordisk A/S
ClinicalTrials.gov Identifier: NCT01487369     History of Changes
Other Study ID Numbers: ANA-1946
Study First Received: November 29, 2011
Last Updated: December 7, 2011
Health Authority: Japan: Ministry of Health, Labour and Welfare (MHLW)

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 1
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Autoimmune Diseases
Immune System Diseases
Antibodies
Insulin aspart
Insulin
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions
Hypoglycemic Agents

ClinicalTrials.gov processed this record on April 21, 2014