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: March 3, 2016
Last verified: March 2016
  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

Ages Eligible for Study:   Child, Adult, Senior
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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 
Study First Received: November 29, 2011
Last Updated: March 3, 2016
Health Authority: Japan: Ministry of Health, Labour and Welfare (MHLW)

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

ClinicalTrials.gov processed this record on August 25, 2016