Post Marketing Surveillance Study of Biphasic Insulin Aspart 30

This study is conducted in Asia. The aim of this study is to review the safety and efficacy of biphasic insulin aspart 30 in post-marketing use.

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Key information

Conditions

Diabetes Autoimmune Diseases Diabetes Mellitus Diabetes Mellitus, Type 1 Diabetes Mellitus, Type 2 Endocrine System Diseases Glucose Metabolism Disorders Immune System Diseases Metabolic Diseases Nutritional and Metabolic Diseases

Sex eligibility

All sexes

Study type

Observational

Primary location

Seoul, 137-920, South Korea

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

Subjects with diabetes who did not have indications that are contraindicated in the product insert

Treatment and study plan

biphasic insulin aspart 30

Drug

The insulin dose and regimen were individualised at the physician's discretion. Insulin was administered by subcutaneous injection using an injection device

Primary outcomes

Change in body weight

Secondary outcomes

Change in fasting plasma glucose (FPG)
Change in HbA1c (glycosylated haemoglobin)
Occurrence of adverse events (non-serious and serious)

Sponsors and collaborators

Lead sponsor

Novo Nordisk A/S

Industry

Registry information

Official study title

NovoMix® 30 FlexPen, Post Marketing Surveillance Study

Important dates

Study start: 2004
Primary completion: 2007
Study completion: 2007
First posted: Feb 22, 2012
Registry last updated: Mar 7, 2016

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.

Published trials that share one or more normalized conditions with this study.

Completed