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

ClinicalTrials.gov Identifier:

NCT00700648

First received: June 18, 2008

Last updated: May 24, 2012

Last verified: May 2012

History of Changes

Tracking Information

First Received Date ^ICMJE

June 18, 2008

Last Updated Date

May 24, 2012

Start Date ^ICMJE

March 2008

Primary Completion Date

September 2008 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

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 ]

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00700648 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Other safety & efficacy measures [ Time Frame: After 6 months ] [ Designated as safety issue: Yes ]

Original Secondary Outcome Measures ^ICMJE

Same as current

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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

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 Provided

Study Type ^ICMJE

Observational

Study Design ^ICMJE

Observational Model: Case-Only
Time Perspective: Prospective

Target Follow-Up Duration

Not Provided

Biospecimen

Not Provided

Sampling Method

Non-Probability Sample

Study Population

Hospitalized subjects requiring intravenous insulin therapy

Condition ^ICMJE

Diabetes
Diabetes Mellitus, Type 1
Diabetes Mellitus, Type 2

Intervention ^ICMJE

Drug: insulin aspart

Intravenous NovoRapid dose & frequency as decided by treating physician

Study Group/Cohort (s)

Intervention: Drug: insulin aspart

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

2957

Completion Date

September 2008

Primary Completion Date

September 2008 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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.

Gender

Both

Ages

Not Provided

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

India

Administrative Information

NCT Number ^ICMJE

NCT00700648

Other Study ID Numbers ^ICMJE

ANA-3531

Has Data Monitoring Committee

Responsible Party

Public Access to Clinical Trials, Novo Nordisk A/S

Study Sponsor ^ICMJE

Novo Nordisk

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Study Director:

Anil Shinde, M.D

Novo Nordisk India Private Limited.

Information Provided By

Novo Nordisk

Verification Date

May 2012

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

To Top