An Observational Study to Assess Safety and Effectiveness of Intravenous NovoRapid® in Hospitalised Subjects

This study has been completed.
Sponsor:
Information provided by:
Novo Nordisk A/S
ClinicalTrials.gov Identifier:
NCT00700648
First received: June 18, 2008
Last updated: August 8, 2014
Last verified: August 2014

June 18, 2008
August 8, 2014
March 2008
September 2008   (final data collection date for primary outcome measure)
  • Incidence of AEs (adverse event) [ Time Frame: After 6 months ] [ Designated as safety issue: Yes ]
  • Incidence of SAEs (serious adverse event) [ Time Frame: After 6 months ] [ Designated as safety issue: Yes ]
Same as current
Complete list of historical versions of study NCT00700648 on ClinicalTrials.gov Archive Site
Other safety & efficacy measures [ Time Frame: After 6 months ] [ Designated as safety issue: Yes ]
Same as current
Not Provided
Not Provided
 
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)

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.

Not Provided
Observational
Observational Model: Case-Only
Time Perspective: Prospective
Not Provided
Not Provided
Non-Probability Sample

Hospitalized subjects requiring intravenous insulin therapy

  • Diabetes
  • Diabetes Mellitus, Type 1
  • Diabetes Mellitus, Type 2
Drug: insulin aspart
Intravenous NovoRapid dose & frequency as decided by treating physician
A
Intervention: Drug: insulin aspart
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
3024
September 2008
September 2008   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Any hospitalized subject with hyperglycaemia requiring intravenous insulin therapy is eligible for the study based on the discretion of the physician.

Exclusion Criteria:

  • 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.
Both
Not Provided
No
Contact information is only displayed when the study is recruiting subjects
India
 
NCT00700648
ANA-3531
No
Not Provided
Novo Nordisk A/S
Not Provided
Study Director: Anil Shinde, M.D Novo Nordisk India Private Limited.
Novo Nordisk A/S
August 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP