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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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7 November 2016 |
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Main ID: |
NCT01490112 |
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Date of registration:
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06/12/2011 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Surveillance Study of NovoRapid® for New Drug Re-examination
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Scientific title:
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Regulatory Post Marketing Surveillance Study of NovoRapid for New Drug Re-examination |
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Date of first enrolment:
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January 2005 |
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Target sample size:
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1239 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT01490112 |
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Study type:
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Observational |
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Study design:
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Observational Model: Cohort, Time Perspective: Prospective
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Phase:
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Countries of recruitment
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Korea, Republic of
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Contacts
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Name:
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Global Clinical Registry (GCR, 1452) |
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Address:
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Telephone:
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Email:
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Affiliation:
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Novo Nordisk A/S |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- Subjects with diabetes mellitus (type 1, type 2, or gestational) prescribed with
insulin aspart (NovoRapid®)
Age minimum:
N/A
Age maximum:
N/A
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Diabetes Mellitus, Type 1
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Diabetes
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Diabetes Mellitus, Type 2
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Intervention(s)
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Drug: insulin aspart
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Primary Outcome(s)
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Change in weight
[Time Frame: No]
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Secondary Outcome(s)
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Fasting blood glucose (FBG)
[Time Frame: No]
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Adverse events: Serious and non-serious
[Time Frame: No]
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HbA1c (glycosylated haemoglobin)
[Time Frame: No]
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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