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

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ClinicalTrials.gov Identifier: NCT01536626
Recruitment Status : Completed
First Posted : February 22, 2012
Last Update Posted : February 24, 2017
Sponsor:
Information provided by (Responsible Party):
Novo Nordisk A/S

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

Study Type : Observational
Actual Enrollment : 211 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: SWITCH Mixtard® 30 NovoLet® to NovoMix® 30 FlexPen®. An Observational Study
Actual Study Start Date : June 9, 2006
Actual Primary Completion Date : April 10, 2007
Actual Study Completion Date : April 10, 2007

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
BIAsp 30 users Drug: biphasic insulin aspart 30
Prescription at the discretion of the treating physician




Primary Outcome Measures :
  1. HbA1c (glycosylated haemoglobin)

Secondary Outcome Measures :
  1. Number of hypoglycaemic events
  2. Treatment satisfaction: ITSQ (Insulin Treatment Satisfaction Questionnaire)
  3. Quality of Life (QoL) using the World Health Organization Wellbeing Index (WHO-5)


Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
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

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): NCT01536626


Locations
Netherlands
Novo Nordisk Investigational Site
Alphen a/d Rijn, Netherlands
Sponsors and Collaborators
Novo Nordisk A/S
Investigators
Study Director: Global Clinical Registry (GCR, 1452) Novo Nordisk A/S

Additional Information:
Responsible Party: Novo Nordisk A/S
ClinicalTrials.gov Identifier: NCT01536626     History of Changes
Other Study ID Numbers: BIASP-1925
First Posted: February 22, 2012    Key Record Dates
Last Update Posted: February 24, 2017
Last Verified: February 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
Insulin Aspart
Insulin, Long-Acting
Biphasic Insulins
Insulin, Isophane
Hypoglycemic Agents
Physiological Effects of Drugs