An Observational Study to Assess Safety and Effectiveness of Intravenous NovoRapid® in Hospitalized Subjects - Full Text View

Sponsored by:	Novo Nordisk
Information provided by:	Novo Nordisk
ClinicalTrials.gov Identifier:	NCT00700648

Purpose

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 hospitalized subjects under normal clinical practice conditions in India.

Condition	Intervention
Diabetes Mellitus	Drug: insulin aspart

MedlinePlus related topics: Diabetes

Drug Information available for: Insulin Insulin aspart

U.S. FDA Resources

Study Type:	Observational
Study Design:	Case-Only, Prospective
Official Title:	An Observational Study on Safety and Efficacy in Hospitalized Subjects Receiving Intravenous NovoRapid® (Insulin Aspart)

Further study details as provided by Novo Nordisk:

Primary Outcome Measures:

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 ]

Secondary Outcome Measures:

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

Biospecimen Retention: None Retained

Biospecimen Description:

Enrollment:	2884
Study Start Date:	April 2008
Study Completion Date:	September 2008
Primary Completion Date:	September 2008 (Final data collection date for primary outcome measure)

Groups/Cohorts	Assigned Interventions
A	Drug: insulin aspart Intravenous NovoRapid dose & frequency as decided by treating physician

Eligibility

Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No
Sampling Method:	Non-Probability Sample

Study Population

Hospitalized subjects requiring intravenous insulin therapy

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00700648

Locations

India

Bangalore, India, 560001

Sponsors and Collaborators

Novo Nordisk

Investigators

Study Director:

Anil Shinde, M.D

Novo Nordisk India Private Limited.

More Information

Clinical Trials at Novo Nordisk This link exits the ClinicalTrials.gov site

Responsible Party:	Novo Nordisk A/S ( Public Access to Clinical Trials )
Study ID Numbers:	ANA-3531
Study First Received:	June 18, 2008
Last Updated:	November 4, 2008
ClinicalTrials.gov Identifier:	NCT00700648
Health Authority:	India: Ministry of Health

Study placed in the following topic categories:

Metabolic Diseases
Insulin, Asp(B28)-
Diabetes Mellitus
Endocrine System Diseases

Endocrinopathy
Metabolic disorder
Glucose Metabolism Disorders
Insulin

Additional relevant MeSH terms:

Hypoglycemic Agents
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 16, 2009