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Observational Safety Study in Subjects With Type 2 Diabetes Mellitus Starting or Switching to Biphasic Insulin Aspart 30 Treatment

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ClinicalTrials.gov Identifier: NCT01548235
Recruitment Status : Completed
First Posted : March 8, 2012
Last Update Posted : January 6, 2017
Information provided by (Responsible Party):
Novo Nordisk A/S

Brief Summary:
This study is conducted in Europe. The aim of this study is to investigate safety and efficacy in subjects with type 2 diabetes mellitus starting or switching to biphasic insulin aspart 30 (NovoMix® 30) treatment.

Condition or disease Intervention/treatment
Diabetes Diabetes Mellitus, Type 2 Drug: biphasic insulin aspart 30

Study Type : Observational
Actual Enrollment : 423 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: A Multicentre, Open Label, Non-randomised, Non-interventional, Observational Safety Study in Subjects With Type 2 Diabetes Mellitus, Starting or Switching to NovoMix® 30 Treatment
Study Start Date : February 2006
Primary Completion Date : April 2007
Study Completion Date : April 2007

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Group/Cohort Intervention/treatment
BIAsp 30 users Drug: biphasic insulin aspart 30
Prescribed biphasic insulin aspart 30 as part of routine care. Starting dose, dose titration and injection frequency determined individually by each physician.

Primary Outcome Measures :
  1. Incidence of SADR (serious adverse drug reactions) including major hypoglycaemia

Secondary Outcome Measures :
  1. Change from baseline in HbA1c (glycosylated haemoglobin)
  2. Mean FPG (fasting plasma glucose)
  3. Overall, daytime and nocturnal frequency of hypoglycaemic events

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

Patients who started insulin therapy with biphasic insulin aspart 30 and subjects who switched from other insulin regimens to biphasic insulin aspart 30 by prescription of their physician as part of routine clinical practice in order to improve glycemic control.

The selection of patients was at the discretion of the treating physician.


Inclusion Criteria:

  • Subjects with type 2 diabetes

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): NCT01548235

Novo Nordisk Investigational Site
Copenhagen S, Denmark, 2300
Sponsors and Collaborators
Novo Nordisk A/S
Study Director: Global Clinical Registry (GCR, 1452) Novo Nordisk A/S

Additional Information:
Responsible Party: Novo Nordisk A/S
ClinicalTrials.gov Identifier: NCT01548235     History of Changes
Other Study ID Numbers: BIASP-1812
First Posted: March 8, 2012    Key Record Dates
Last Update Posted: January 6, 2017
Last Verified: January 2017

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Insulin, Globin Zinc
Insulin degludec, insulin aspart drug combination
Insulin aspart, insulin aspart protamine drug combination 30:70
Insulin Aspart
Insulin, Long-Acting
Biphasic Insulins
Insulin, Isophane
Hypoglycemic Agents
Physiological Effects of Drugs