Switch From Premixed Human Insulin to Biphasic Insulin Aspart in the Netherlands (SWITCH)

This study has been completed.
Sponsor:
Information provided by:
Novo Nordisk A/S
ClinicalTrials.gov Identifier:
NCT01536626
First received: February 16, 2012
Last updated: NA
Last verified: February 2012
History: No changes posted
  Purpose

This study is conducted in Europe. The aim of this observational study is to observe and investigate the process of switching from premixed human insulin 30/70 (BHI 30) to biphasic insulin aspart 30/70 (BIAsp 30) in an outpatient setting.


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: SWITCH Mixtard® 30 NovoLet® to NovoMix® 30 FlexPen®. An Observational Study

Resource links provided by NLM:


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

Primary Outcome Measures:
  • HbA1c (glycosylated haemoglobin) [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Number of hypoglycaemic events [ Designated as safety issue: No ]
  • Treatment satisfaction: ITSQ (Insulin Treatment Satisfaction Questionnaire) [ Designated as safety issue: No ]
  • Quality of Life (QoL) using the World Health Organization Wellbeing Index (WHO-5) [ Designated as safety issue: No ]

Enrollment: 211
Study Start Date: June 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
Prescription at the discretion of the treating physician

  Eligibility

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

Patients with type 2 diabetes treated with BHI 30 who have been by the physician for some reason switched to BIAsp 30

Criteria

Inclusion Criteria:

  • Type 2 diabetic subjects treated with BHI 30
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01536626

Locations
Netherlands
Alphen a/d Rijn, Netherlands
Sponsors and Collaborators
Novo Nordisk A/S
Investigators
Study Director: Helene Philippo Novo Nordisk B.V.
  More Information

Additional Information:
No publications provided

Responsible Party: Public Access to Clinical Trials, Novo Nordisk A/S
ClinicalTrials.gov Identifier: NCT01536626     History of Changes
Other Study ID Numbers: BIASP-1925
Study First Received: February 16, 2012
Last Updated: February 16, 2012
Health Authority: Netherlands: Dutch Health Care Inspectorate

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 April 17, 2014