Observational Study of Safety and Effectiveness of NovoMix® 30 for the Treatment of Diabetes

This study is conducted in Asia, Europe, Japan and North America. The aim of this observational study is to evaluate the safety and effectiveness while using NovoMix® 30 during 26 weeks under normal clinical practice, in the countries participating in the study. The primary outcome is the incidence of major hypoglycaemic events reported as serious adverse drugs reaction conditions on hypoglycaemic events.

Completed

Looking for future studies?

Notify Me

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, Mississauga, Canada

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

Age according to approved label and physician discretion
Type 2 diabetes including newly-diagnosed subjects who have never received insulin or an insulin analogue before

Exclusion criteria

Subjects who previously enrolled in this study
Subjects who are unlikely to comply with protocol requirements
Hypersensitivity to biphasic insulin aspart or to any of the excipients
Women who are pregnant, breast feeding or have the intention of becoming pregnant within next 12 months

Treatment and study plan

biphasic insulin aspart

Drug

Start dose and frequency to be prescribed by the physician as a result of a normal clinical evaluation.

Other names: BIASP, NovoMix 30, NovoLog Mix 70/30

Primary outcomes

Incidence of major hypoglycaemic events reported as serious adverse drug reactions

Time frame: during treatment

Sponsors and collaborators

Lead sponsor

Novo Nordisk A/S

Industry

Registry information

Official study title

Observational Study of Safety and Effectiveness of NovoMix® 30 (Biphasic Insulin Aspart) for the Treatment of Diabetes Mellitus

Acronym: IMPROVE™

Important dates

Study start: 2006
Primary completion: 2008
Study completion: 2008
First posted: Apr 16, 2008
Registry last updated: Jan 12, 2018

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