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Surveillance Study of NovoRapid® for New Drug Re-examination

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01490112
First Posted: December 12, 2011
Last Update Posted: October 28, 2016
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.
Information provided by (Responsible Party):
Novo Nordisk A/S
  Purpose
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 Intervention Phase
Diabetes Diabetes Mellitus, Type 1 Diabetes Mellitus, Type 2 Drug: insulin aspart Phase 4

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Regulatory Post Marketing Surveillance Study of NovoRapid for New Drug Re-examination

Resource links provided by NLM:


Further study details as provided by Novo Nordisk A/S:

Primary Outcome Measures:
  • Change in weight

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

Enrollment: 1239
Study Start Date: January 2005
Study Completion Date: June 2006
Primary Completion Date: June 2006 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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

  Eligibility

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®)
  Contacts and Locations
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
  More Information

Additional Information:
Responsible Party: Novo Nordisk A/S
ClinicalTrials.gov Identifier: NCT01490112     History of Changes
Other Study ID Numbers: ANA-1881
First Submitted: December 6, 2011
First Posted: December 12, 2011
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