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

Diabetes Mellitus, Type 2 Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00700648
• Other study ID #: ANA-3531
• Status: Completed
• Phase: N/A
• First received: June 18, 2008
• Last updated: January 2, 2017
• Start date: March 2008
• Est. completion date: September 2008

Study information

• Verified date: January 2017
• Source: Novo Nordisk A/S
• Contact: n/a
• Is FDA regulated: No
• Health authority: India: Ministry of Health
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 3024
• Est. completion date: September 2008
• Est. primary completion date: September 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

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

Observational Model: Case-Only, Time Perspective: Prospective

Related Conditions & MeSH terms

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

Intervention

Drug:
• insulin aspart
Intravenous NovoRapid dose & frequency as decided by treating physician

Locations

Country	Name	City	State
India	Novo Nordisk Investigational Site	Bangalore

Sponsors (1)

Lead Sponsor	Collaborator
Novo Nordisk A/S

Country where clinical trial is conducted

India, 

References & 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

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of AEs (adverse event)		After 6 months	Yes
Primary	Incidence of SAEs (serious adverse event)		After 6 months	Yes
Secondary	Other safety & efficacy measures		After 6 months	Yes

External Links

•   Clinical Trials at Novo Nordisk