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OpenTrials
Completed

NCT Number: NCT01536626

Switch From Premixed Human Insulin to Biphasic Insulin Aspart in the Netherlands

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.

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Key information

Conditions

Diabetes Diabetes Mellitus Diabetes Mellitus, Type 2 Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Sex eligibility

All sexes

Study type

Observational

Primary location

Novo Nordisk Investigational Site

Alphen aan den Rijn, Netherlands

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Type 2 diabetic subjects treated with BHI 30

Treatment and study plan

biphasic insulin aspart 30

Drug

Prescription at the discretion of the treating physician

Primary outcomes

  1. HbA1c (glycosylated haemoglobin)

Secondary outcomes

  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)

Sponsors and collaborators

Lead sponsor

Novo Nordisk A/S

Industry

Registry information

Official study title

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

Acronym: SWITCH

Important dates

Study start
2006
Primary completion
2007
Study completion
2007
First posted
Feb 22, 2012
Registry last updated
Feb 24, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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