Special Survey for Patients With Type 1 or Type 2 Diabetes

This study has been completed.
Sponsor:
Information provided by:
Novo Nordisk A/S
ClinicalTrials.gov Identifier:
NCT01538589
First received: February 15, 2012
Last updated: February 20, 2012
Last verified: February 2012
  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 ] [ Designated as safety issue: No ]
  • Occurrence of severe hypoglycaemic symptoms [ Time Frame: Year 2 for patients who had an antibody titre test performed ] [ Designated as safety issue: No ]
  • Antibody titre findings [ Time Frame: Year 1 ] [ Designated as safety issue: No ]
  • Antibody titre findings [ Time Frame: Year 2 for patients who had an antibody titre test performed ] [ Designated as safety issue: No ]
  • Adverse events [ Time Frame: Year 1 ] [ Designated as safety issue: No ]
  • Adverse events [ Time Frame: Year 2 for patients who had an antibody titre test performed ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Response rate assessed by the investigator: Ability or failure to achieve expected glycaemic control [ Time Frame: Year 1 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • HbA1c (glycosylated haemoglobin) [ Time Frame: Year 1 ] [ Designated as safety issue: No ]
  • HbA1c (glycosylated haemoglobin) [ Time Frame: Year 2 for patients who had an antibody titre test performed ] [ Designated as safety issue: No ]
  • Total dose of insulin infused subcutaneously [ Time Frame: Year 1 ] [ Designated as safety issue: No ]
  • Total dose of insulin infused subcutaneously [ Time Frame: Year 2 for patients who had an antibody titre test performed ] [ Designated as safety issue: No ]

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

Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01538589

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: Public Access to Clinical Trials, Novo Nordisk A/S
ClinicalTrials.gov Identifier: NCT01538589     History of Changes
Other Study ID Numbers: BIASP-1943
Study First Received: February 15, 2012
Last Updated: February 20, 2012
Health Authority: Japan: Ministry of Health, Labor and Welfare

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
Insulin aspart
Insulin
Hypoglycemic Agents
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on April 17, 2014