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Post Marketing Surveillance Study of Biphasic Insulin Aspart 30

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01536613
First Posted: February 22, 2012
Last Update Posted: March 7, 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 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:


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

Primary Outcome Measures:
  • Change in body weight

Secondary Outcome Measures:
  • Change in fasting plasma glucose (FPG)
  • Change in HbA1c (glycosylated haemoglobin)
  • Occurrence of adverse events (non-serious and serious)

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

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
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
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): NCT01536613


Locations
Korea, Republic of
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: NCT01536613     History of Changes
Other Study ID Numbers: BIASP-1883
First Submitted: February 16, 2012
First Posted: February 22, 2012
Last Update Posted: March 7, 2016
Last Verified: March 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, Globin Zinc
Insulin degludec, insulin aspart drug combination
Insulin aspart, insulin aspart protamine drug combination 30:70
Insulin
Insulin Aspart
Insulin, Long-Acting
Biphasic Insulins
Insulin, Isophane
Hypoglycemic Agents
Physiological Effects of Drugs