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

Completed

• Conditions: Diabetes; Diabetes Mellitus, Type 1; Diabetes Mellitus, Type 2
• Interventions: Drug: insulin aspart

• Registration Number: NCT00700648
• Lead Sponsor: Novo Nordisk A/S

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2008-03
• Study First Submitted: 2008-06-18
• Study First Submitted QC: 2008-06-18
• Study First Posted: 2008-06-19
• Primary Completion: 2008-09
• Study Completion: 2008-09
• Status Verified: 2017-01
• Last Update Submitted: 2017-01-02
• Last Update Posted: 2017-01-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 3024

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
A	insulin aspart	-

Primary Outcome Measures

Name	Time	Method
Incidence of SAEs (serious adverse event)	After 6 months
Incidence of AEs (adverse event)	After 6 months

Secondary Outcome Measures

Name	Time	Method
Other safety & efficacy measures	After 6 months

Trial Locations

Locations (1)

Novo Nordisk Investigational Site; 🇮🇳 Bangalore, India