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)

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT00700648

Enrollment

3024

Registered

2008-06-19

Start date

2008-03-31

Completion date

2008-09-30

Last updated

2017-01-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Diabetes, Diabetes Mellitus, Type 1, Diabetes Mellitus, Type 2

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.

Interventions

DRUGinsulin aspart

Intravenous NovoRapid dose & frequency as decided by treating physician

Study design

Observational model

CASE_ONLY

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame
Incidence of AEs (adverse event)	After 6 months
Incidence of SAEs (serious adverse event)	After 6 months

Secondary

Measure	Time frame
Other safety & efficacy measures	After 6 months

Countries

India

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026