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Observational Study to Assess the Efficacy and Safety of NovoRapid™ Flexpen™

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: NCT00675220
Recruitment Status : Completed
First Posted : May 9, 2008
Last Update Posted : October 28, 2016
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 collect efficacy and safety data in diabetic patients with acute hyperglycemia using NovoRapid™ FlexPen™ as per normal clinical practice.

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

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Study Type : Observational
Actual Enrollment : 373 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: A Prospective, Open-Labelled, Non-Controlled, Observational Study to Assess the Efficacy and Safety of NovoRapid™ FlexPen™ in the Treatment of Acute Hyperglycemia: A Post-Marketing Surveillance Study
Study Start Date : June 2007
Actual Primary Completion Date : December 2007
Actual Study Completion Date : December 2007

Resource links provided by the National Library of Medicine

Group/Cohort Intervention/treatment
A Drug: insulin aspart
Start dose and frequency to be prescribed by the physician as a result of the normal clinical evaluation

Primary Outcome Measures :
  1. Safety profile of Insulin Aspart among Filipino patients [ Time Frame: 1-month follow-up for outpatients; 1 month or upon discharge for inpatients whichever comes first ]

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients with Diabetes

Inclusion Criteria:

  • Patients with diabetes mellitus (according to product labelling)

Exclusion Criteria:

  • Hypoglycaemia
  • Hypersensitivity to insulin aspart or to any of the excipients (according to product labelling)

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): NCT00675220

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Novo Nordisk Investigational Site
Manilla, Philippines, 1605
Sponsors and Collaborators
Novo Nordisk A/S
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Study Director: Global Clinical Registry (GCR, 1452) Novo Nordisk A/S

Additional Information:
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Responsible Party: Novo Nordisk A/S Identifier: NCT00675220     History of Changes
Other Study ID Numbers: ANA-1884
First Posted: May 9, 2008    Key Record Dates
Last Update Posted: October 28, 2016
Last Verified: October 2016

Additional relevant MeSH terms:
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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