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Special Survey for Type 1 or Type 2 Diabetic Patients

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Novo Nordisk
ClinicalTrials.gov Identifier:
NCT01487408
First received: November 29, 2011
Last updated: December 7, 2011
Last verified: December 2011
History of Changes
  Purpose

This study is conducted in Japan. The aim of this study is to evaluate the incidence of severe hypoglycaemia episodes under normal clinical practice for patients with type 1 or type 2 diabetes.


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:

U.S. FDA Resources

Further study details as provided by Novo Nordisk:

Primary Outcome Measures:
  • HbA1c (glycosylated haemoglobin) [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Incidence of servere hypoglycaemia [ Designated as safety issue: No ]
  • Total dose of insulin (aspart/human insulin) infused subcutaneously [ Designated as safety issue: No ]
  • Physical examination [ Designated as safety issue: No ]
  • Adverse events [ Designated as safety issue: No ]

Enrollment: 1463
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
Adminstered subcutaneously (s.c., under the skin). Prescribed by physician as a results of normal clinical practice

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Patients with type 1 or type 2 diabetes.

Criteria

Inclusion Criteria:

  • Patients with diabetes requiring insulin therapy

Exclusion Criteria:

  • Patients who had not been treated more than 3 months at the same investigational site
  • Patients who had treatment history of NovoRapid® (insulin aspart)
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01487408

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

Additional Information:
Clinical Trials at Novo Nordisk  This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party: Novo Nordisk
ClinicalTrials.gov Identifier: NCT01487408     History of Changes
Other Study ID Numbers: ANA-1944
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
Insulin aspart
Insulin
Hypoglycemic Agents
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 16, 2013