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

This study has been completed.
Sponsor:
Information provided by:
Novo Nordisk
ClinicalTrials.gov Identifier:
NCT01548235
First received: March 5, 2012
Last updated: NA
Last verified: March 2012
History: No changes posted
  Purpose

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

Study Type: Observational
Study Design: 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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Novo Nordisk:

Primary Outcome Measures:
  • Incidence of SADR (serious adverse drug reactions) including major hypoglycaemia [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Change from baseline in HbA1c (glycosylated haemoglobin) [ Designated as safety issue: No ]
  • Mean FPG (fasting plasma glucose) [ Designated as safety issue: No ]
  • Overall, daytime and nocturnal frequency of hypoglycaemic events [ Designated as safety issue: No ]

Enrollment: 423
Study Start Date: February 2006
Study Completion Date: April 2007
Primary Completion Date: April 2007 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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.

  Eligibility

Genders Eligible for Study:   Both
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.

Criteria

Inclusion Criteria:

  • Subjects with type 2 diabetes
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01548235

Locations
Denmark
Copenhagen S, Denmark, 2300
Sponsors and Collaborators
Novo Nordisk
Investigators
Study Director: Erik Christiansen Novo Nordisk Scandinavia AB
  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: NCT01548235     History of Changes
Other Study ID Numbers: BIASP-1812
Study First Received: March 5, 2012
Last Updated: March 5, 2012
Health Authority: Denmark: Danish Medicines Agency

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Insulin aspart
 Insulin
Insulin, NPH
Hypoglycemic Agents
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on June 18, 2013