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Surveillance Study of NovoRapid® for New Drug Re-examination

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ClinicalTrials.gov Identifier: NCT01490112
Recruitment Status : Completed
First Posted : December 12, 2011
Last Update Posted : October 28, 2016
Sponsor:
Information provided by (Responsible Party):
Novo Nordisk A/S

Brief Summary:
This study is conducted in Asia. The aim of this study is to observe the safety and efficacy of insulin aspart (NovoRapid®) administered via vial and three different devices.

Condition or disease Intervention/treatment Phase
Diabetes Diabetes Mellitus, Type 1 Diabetes Mellitus, Type 2 Drug: insulin aspart Phase 4

Study Type : Observational
Actual Enrollment : 1239 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Regulatory Post Marketing Surveillance Study of NovoRapid for New Drug Re-examination
Study Start Date : January 2005
Primary Completion Date : June 2006
Study Completion Date : June 2006

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Group/Cohort Intervention/treatment
IAsp Drug: insulin aspart
Subjects who had a first drug date on NovoRapid® were prescribed to inject insulin aspart using vial, FlexPen, NovoLet or Penfill devices. Injected subcutaneously (s.c., under the skin) immediately before meals for 24 weeks



Primary Outcome Measures :
  1. Change in weight

Secondary Outcome Measures :
  1. Fasting blood glucose (FBG)
  2. HbA1c (glycosylated haemoglobin)
  3. Adverse events: Serious and non-serious


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
People with diabetes mellitus (type 1, type 2, or gestational) prescribed with insulin aspart (NovoRapid®)
Criteria

Inclusion Criteria:

  • Subjects with diabetes mellitus (type 1, type 2, or gestational) prescribed with insulin aspart (NovoRapid®)

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 ClinicalTrials.gov identifier (NCT number): NCT01490112


Locations
Korea, Republic of
Novo Nordisk Investigational Site
Seoul, Korea, Republic of, 137-920
Sponsors and Collaborators
Novo Nordisk A/S
Investigators
Study Director: Global Clinical Registry (GCR, 1452) Novo Nordisk A/S

Additional Information:
Responsible Party: Novo Nordisk A/S
ClinicalTrials.gov Identifier: NCT01490112     History of Changes
Other Study ID Numbers: ANA-1881
First Posted: December 12, 2011    Key Record Dates
Last Update Posted: October 28, 2016
Last Verified: October 2016

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
Insulin Aspart
Hypoglycemic Agents
Physiological Effects of Drugs