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Special Survey for Type 1 or Type 2 Diabetic Patients

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ClinicalTrials.gov Identifier: NCT01487408
Recruitment Status : Completed
First Posted : December 7, 2011
Last Update Posted : March 4, 2016
Sponsor:
Information provided by (Responsible Party):
Novo Nordisk A/S

Brief Summary:
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 or disease Intervention/treatment
Diabetes Diabetes Mellitus, Type 1 Diabetes Mellitus, Type 2 Drug: insulin aspart

Study Type : Observational
Actual Enrollment : 1463 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Special Survey for Type 1 or Type 2 Diabetic Patients
Study Start Date : April 2002
Actual Primary Completion Date : October 2009
Actual Study Completion Date : October 2009

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Group/Cohort Intervention/treatment
Insulin Aspart Drug: insulin aspart
Adminstered subcutaneously (s.c., under the skin). Prescribed by physician as a results of normal clinical practice



Primary Outcome Measures :
  1. HbA1c (glycosylated haemoglobin)

Secondary Outcome Measures :
  1. Incidence of servere hypoglycaemia
  2. Total dose of insulin (aspart/human insulin) infused subcutaneously
  3. Physical examination
  4. Adverse events


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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 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)

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): NCT01487408


Locations
Japan
Tokyo, Japan, 1000005
Sponsors and Collaborators
Novo Nordisk A/S
Investigators
Study Director: Global Clinical Registry (GCR, 1452) Novo Nordisk A/S

Additional Information:
Responsible Party: Novo Nordisk A/S
ClinicalTrials.gov Identifier: NCT01487408     History of Changes
Other Study ID Numbers: ANA-1944
First Posted: December 7, 2011    Key Record Dates
Last Update Posted: March 4, 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