- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01538589
Special Survey for Patients With Type 1 or Type 2 Diabetes
March 3, 2016 updated by: Novo Nordisk A/S
Special Survey for Type 1 or Type 2 Diabetic Patients
This study is conducted in Japan.
The aim of this study is to evaluate the incidence of severe hypoglycaemia under normal clinical practice.
Study Overview
Status
Completed
Intervention / Treatment
Study Type
Observational
Enrollment (Actual)
1582
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Tokyo, Japan, 1000005
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- ADULT
- OLDER_ADULT
- CHILD
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
Patients with diabetes requiring insulin therapy with no treatment history of insulin aspart (NovoRapid®)
Description
Inclusion Criteria:
- Patients with no treatment history of insulin aspart (NovoRapid®)
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
Insulin aspart users
|
Prescribed by the physicians as a result of normal clinical practice
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Occurrence of severe hypoglycaemic symptoms
Time Frame: Year 1
|
Year 1
|
Occurrence of severe hypoglycaemic symptoms
Time Frame: Year 2 for patients who had an antibody titre test performed
|
Year 2 for patients who had an antibody titre test performed
|
Antibody titre findings
Time Frame: Year 1
|
Year 1
|
Antibody titre findings
Time Frame: Year 2 for patients who had an antibody titre test performed
|
Year 2 for patients who had an antibody titre test performed
|
Adverse events
Time Frame: Year 1
|
Year 1
|
Adverse events
Time Frame: Year 2 for patients who had an antibody titre test performed
|
Year 2 for patients who had an antibody titre test performed
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Response rate assessed by the investigator: Ability or failure to achieve expected glycaemic control
Time Frame: Year 1
|
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
|
Year 2 for patients who had an antibody titre test performed
|
HbA1c (glycosylated haemoglobin)
Time Frame: Year 1
|
Year 1
|
HbA1c (glycosylated haemoglobin)
Time Frame: Year 2 for patients who had an antibody titre test performed
|
Year 2 for patients who had an antibody titre test performed
|
Total dose of insulin infused subcutaneously
Time Frame: Year 1
|
Year 1
|
Total dose of insulin infused subcutaneously
Time Frame: Year 2 for patients who had an antibody titre test performed
|
Year 2 for patients who had an antibody titre test performed
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Helpful Links
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
December 1, 2003
Primary Completion (ACTUAL)
October 1, 2009
Study Completion (ACTUAL)
October 1, 2009
Study Registration Dates
First Submitted
February 15, 2012
First Submitted That Met QC Criteria
February 20, 2012
First Posted (ESTIMATE)
February 24, 2012
Study Record Updates
Last Update Posted (ESTIMATE)
March 7, 2016
Last Update Submitted That Met QC Criteria
March 3, 2016
Last Verified
March 1, 2016
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- BIASP-1943
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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