Surveillance Study of NovoRapid® for New Drug Re-examination

This study has been completed.
Information provided by:
Novo Nordisk A/S Identifier:
First received: December 6, 2011
Last updated: December 8, 2011
Last verified: December 2011

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

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 [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Fasting blood glucose (FBG) [ Designated as safety issue: No ]
  • HbA1c (glycosylated haemoglobin) [ Designated as safety issue: No ]
  • Adverse events: Serious and non-serious [ Designated as safety issue: No ]

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


Genders Eligible for Study:   Both
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®)


Inclusion Criteria:

  • Subjects with diabetes mellitus (type 1, type 2, or gestational) prescribed with insulin aspart (NovoRapid®)
  Contacts and Locations
Please refer to this study by its identifier: NCT01490112

Korea, Republic of
Seoul, Korea, Republic of, 137-920
Sponsors and Collaborators
Novo Nordisk A/S
Study Director: Henning Andersen Novo Nordisk A/S
  More Information

Additional Information:
No publications provided

Responsible Party: Public Access to Clinical Trials, Novo Nordisk A/S Identifier: NCT01490112     History of Changes
Other Study ID Numbers: ANA-1881
Study First Received: December 6, 2011
Last Updated: December 8, 2011
Health Authority: South Korea: Korea Food and Drug Administration (KFDA)

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
Hypoglycemic Agents
Physiological Effects of Drugs
Pharmacologic Actions processed this record on April 17, 2014