Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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
Endocrine System Diseases
Glucose Metabolism Disorders
Metabolic Diseases
Biphasic Insulins
Insulin
Insulin Aspart
Insulin aspart, insulin aspart protamine drug combination 30:70
Insulin, Isophane
Hypoglycemic Agents
Pharmacologic Actions
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on November 24, 2014