An Observational Study to Assess Safety and Effectiveness of Intravenous NovoRapid® in Hospitalised Subjects
A Multicenter, Open Label, Nonrandomized, Non Interventional, Observational, Safety and Efficacy Study in Hospitalized Subjects Using Intravenous NovoRapid® (Insulin Aspart)
1 other identifier
observational
3,024
1 country
1
Brief Summary
This study is conducted in Asia. The aim of this observational study is to evaluate the side effects profile and benefits of using intravenous insulin aspart infusion in hospitalised subjects under normal clinical practice conditions in India.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Mar 2008
Shorter than P25 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 1, 2008
CompletedFirst Submitted
Initial submission to the registry
June 18, 2008
CompletedFirst Posted
Study publicly available on registry
June 19, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2008
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2008
CompletedJanuary 4, 2017
January 1, 2017
6 months
June 18, 2008
January 2, 2017
Conditions
Outcome Measures
Primary Outcomes (2)
Incidence of AEs (adverse event)
After 6 months
Incidence of SAEs (serious adverse event)
After 6 months
Secondary Outcomes (1)
Other safety & efficacy measures
After 6 months
Study Arms (1)
A
Interventions
Eligibility Criteria
Hospitalized subjects requiring intravenous insulin therapy
You may qualify if:
- Any hospitalized subject with hyperglycaemia requiring intravenous insulin therapy is eligible for the study based on the discretion of the physician.
You may not qualify if:
- Subjects who are unlikely to comply with protocol, e.g., uncooperative attitude;
- Subjects with a hypersensitivity to NovoRapid or to any of the excipients.
- Subjects with conditions considered as contraindications.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Novo Nordisk A/Slead
Study Sites (1)
Novo Nordisk Investigational Site
Bangalore, 560001, India
Related Publications (1)
Intravenous insulin aspart in a hospital setting: results from an observational study examining patient outcomes and physician preferences; Udwadia F, Bhattacharyya A, Seshiah V et al.; Diabetes Manage. (2012) 2(2), 103-110
RESULT
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Global Clinical Registry (GCR, 1452)
Novo Nordisk A/S
Study Design
- Study Type
- observational
- Observational Model
- CASE ONLY
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 18, 2008
First Posted
June 19, 2008
Study Start
March 1, 2008
Primary Completion
September 1, 2008
Study Completion
September 1, 2008
Last Updated
January 4, 2017
Record last verified: 2017-01