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Post Marketing Surveillance Study of Biphasic Insulin Aspart 30

This study has been completed.
Sponsor:
Information provided by:
Novo Nordisk
ClinicalTrials.gov Identifier:
NCT01536613
First received: February 16, 2012
Last updated: April 11, 2012
Last verified: April 2012
History of Changes
  Purpose

This study is conducted in Asia. The aim of this study is to review the safety and efficacy of biphasic insulin aspart 30 in post-marketing use.


Condition Intervention
Diabetes
Diabetes Mellitus, Type 1
Diabetes Mellitus, Type 2
 Drug: biphasic insulin aspart 30

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: NovoMix® 30 FlexPen, Post Marketing Surveillance Study

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Novo Nordisk:

Primary Outcome Measures:
  • Change in body weight [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Change in fasting plasma glucose (FPG) [ Designated as safety issue: No ]
  • Change in HbA1c (glycosylated haemoglobin) [ Designated as safety issue: No ]
  • Occurrence of adverse events (non-serious and serious) [ Designated as safety issue: No ]

Enrollment: 5346
Study Start Date: September 2004
Study Completion Date: February 2007
Primary Completion Date: February 2007 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
BIAsp 30 users Drug: biphasic insulin aspart 30
The insulin dose and regimen were individualised at the physician's discretion. Insulin was administered by subcutaneous injection using an injection device

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Subjects with diabetes who did not have indications that are contraindicated in the product insert

Criteria

Inclusion Criteria:

  • Subjects with diabetes who did not have indications that are contraindicated in the product insert
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01536613

Locations
Korea, Republic of
Seoul, Korea, Republic of, 137-920
Sponsors and Collaborators
Novo Nordisk
Investigators
Study Director: Corporate Vice President for diabetes and devices Novo Nordisk
  More Information

Additional Information:
Clinical Trials at Novo Nordisk  This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party: Public Access to Clinical Trials, Novo Nordisk A/S
ClinicalTrials.gov Identifier: NCT01536613     History of Changes
Other Study ID Numbers: BIASP-1883
Study First Received: February 16, 2012
Last Updated: April 11, 2012
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
Insulin
Insulin, NPH
Hypoglycemic Agents
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on June 18, 2013