- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01490112
Surveillance Study of NovoRapid® for New Drug Re-examination
October 26, 2016 updated by: Novo Nordisk A/S
Regulatory Post Marketing Surveillance Study of NovoRapid for New Drug Re-examination
This study is conducted in Asia.
The aim of this study is to observe the safety and efficacy of insulin aspart (NovoRapid®) administered via vial and three different devices.
Study Overview
Status
Completed
Intervention / Treatment
Study Type
Observational
Enrollment (Actual)
1239
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
-
-
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Seoul, Korea, Republic of, 137-920
- Novo Nordisk Investigational Site
-
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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
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
People with diabetes mellitus (type 1, type 2, or gestational) prescribed with insulin aspart (NovoRapid®)
Description
Inclusion Criteria:
- Subjects with diabetes mellitus (type 1, type 2, or gestational) prescribed with 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 |
---|---|
IAsp
|
Subjects who had a first drug date on NovoRapid® were prescribed to inject insulin aspart using vial, FlexPen, NovoLet or Penfill devices.
Injected subcutaneously (s.c., under the skin) immediately before meals for 24 weeks
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
---|
Change in weight
|
Secondary Outcome Measures
Outcome Measure |
---|
HbA1c (glycosylated haemoglobin)
|
Fasting blood glucose (FBG)
|
Adverse events: Serious and non-serious
|
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
January 1, 2005
Primary Completion (Actual)
June 1, 2006
Study Completion (Actual)
June 1, 2006
Study Registration Dates
First Submitted
December 6, 2011
First Submitted That Met QC Criteria
December 8, 2011
First Posted (Estimate)
December 12, 2011
Study Record Updates
Last Update Posted (Estimate)
October 28, 2016
Last Update Submitted That Met QC Criteria
October 26, 2016
Last Verified
October 1, 2016
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- ANA-1881
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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