A Multicenter, Open Label, Nonrandomized, Non Interventional, Observational, Safety and Efficacy Study in Hospitalized Subjects Using Intravenous NovoRapid® (Insulin Aspart)

Novo Nordisk A/S1 site in 1 country3,024 target enrollmentMarch 2008

ConditionsDiabetes Diabetes Mellitus, Type 1 Diabetes Mellitus, Type 2

Interventionsinsulin aspart

Drugsinsulin aspart

Overview

Phase: Not Applicable
Intervention: insulin aspart
Conditions: Diabetes
Sponsor: Novo Nordisk A/S
Enrollment: 3024
Locations: 1
Primary Endpoint: Incidence of SAEs (serious adverse event)
Status: Completed
Last Updated: 9 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

March 2008

End Date

September 2008

Last Updated

9 years ago

Study Type

Observational

Sex

All

Investigators

Sponsor

Novo Nordisk A/S

Responsible Party

Sponsor

Eligibility Criteria

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.