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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
  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 hospitalised subjects under normal clinical practice conditions in India.


Condition Intervention
Diabetes
Diabetes Mellitus, Type 1
Diabetes Mellitus, Type 2
 Drug: insulin aspart

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: A Multicenter, Open Label, Nonrandomized, Non Interventional, Observational, Safety and Efficacy Study in Hospitalized Subjects Using Intravenous NovoRapid® (Insulin Aspart)

Resource links provided by NLM:

U.S. FDA Resources

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 ]

Enrollment: 2957
Study Start Date: March 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

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

No publications provided

Responsible Party: Public Access to Clinical Trials, Novo Nordisk A/S
ClinicalTrials.gov Identifier: NCT00700648     History of Changes
Other Study ID Numbers: ANA-3531
Study First Received: June 18, 2008
Last Updated: May 24, 2012
Health Authority: India: Ministry of Health

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 1
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Autoimmune Diseases
 Immune System Diseases
Insulin aspart
Insulin
Hypoglycemic Agents
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 16, 2013