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Special Survey for Patients With Type 1 or Type 2 Diabetes

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01538589
First Posted: February 24, 2012
Last Update Posted: March 7, 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 evaluate the incidence of severe hypoglycaemia under normal clinical practice.

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 Type 1 or Type 2 Diabetic Patients

Resource links provided by NLM:


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

Primary Outcome Measures:
  • Occurrence of severe hypoglycaemic symptoms [ Time Frame: Year 1 ]
  • Occurrence of severe hypoglycaemic symptoms [ Time Frame: Year 2 for patients who had an antibody titre test performed ]
  • Antibody titre findings [ Time Frame: Year 1 ]
  • Antibody titre findings [ Time Frame: Year 2 for patients who had an antibody titre test performed ]
  • Adverse events [ Time Frame: Year 1 ]
  • Adverse events [ Time Frame: Year 2 for patients who had an antibody titre test performed ]

Secondary Outcome Measures:
  • Response rate assessed by the investigator: Ability or failure to achieve expected glycaemic control [ Time Frame: Year 1 ]
  • Response rate assessed by the investigator: Ability or failure to achieve expected glycaemic control [ Time Frame: Year 2 for patients who had an antibody titre test performed ]
  • HbA1c (glycosylated haemoglobin) [ Time Frame: Year 1 ]
  • HbA1c (glycosylated haemoglobin) [ Time Frame: Year 2 for patients who had an antibody titre test performed ]
  • Total dose of insulin infused subcutaneously [ Time Frame: Year 1 ]
  • Total dose of insulin infused subcutaneously [ Time Frame: Year 2 for patients who had an antibody titre test performed ]

Enrollment: 1582
Study Start Date: December 2003
Study Completion Date: October 2009
Primary Completion Date: October 2009 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Insulin aspart users Drug: insulin aspart
Prescribed by the physicians as a result of normal clinical practice

  Eligibility

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 with no treatment history of insulin aspart (NovoRapid®)
Criteria

Inclusion Criteria:

  • Patients with no treatment history of insulin aspart (NovoRapid®)
  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): NCT01538589


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: NCT01538589     History of Changes
Other Study ID Numbers: BIASP-1943
First Submitted: February 15, 2012
First Posted: February 24, 2012
Last Update Posted: March 7, 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