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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00700648
Recruitment Status : Completed
First Posted : June 19, 2008
Last Update Posted : January 4, 2017
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment
Diabetes Diabetes Mellitus, Type 1 Diabetes Mellitus, Type 2 Drug: insulin aspart

Study Type : Observational
Actual Enrollment : 3024 participants
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)
Study Start Date : March 2008
Actual Primary Completion Date : September 2008
Actual Study Completion Date : September 2008

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Group/Cohort Intervention/treatment
A Drug: insulin aspart
Intravenous NovoRapid dose & frequency as decided by treating physician

Primary Outcome Measures :
  1. Incidence of AEs (adverse event) [ Time Frame: After 6 months ]
  2. Incidence of SAEs (serious adverse event) [ Time Frame: After 6 months ]

Secondary Outcome Measures :
  1. Other safety & efficacy measures [ Time Frame: After 6 months ]

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Hospitalized subjects requiring intravenous insulin therapy

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00700648

Novo Nordisk Investigational Site
Bangalore, India, 560001
Sponsors and Collaborators
Novo Nordisk A/S
Study Director: Global Clinical Registry (GCR, 1452) Novo Nordisk A/S

Additional Information:
Publications of Results:
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

Responsible Party: Novo Nordisk A/S Identifier: NCT00700648     History of Changes
Other Study ID Numbers: ANA-3531
First Posted: June 19, 2008    Key Record Dates
Last Update Posted: January 4, 2017
Last Verified: January 2017

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