Skip to main content
OpenTrials
Completed

NCT Number: NCT00696163

Observational Study to Assess the Quality of Life and Clinical Outcomes in Subjects Using NovoMix® 30 for the Treatment of Diabetes

This study is conducted in Asia. The aim of this observational study is to evaluate the quality of life and clinical outcomes in subjects using NovoMix® 30 (biphasic insulin aspart 30) for the treatment of diabetes mellitus under normal clinical practice conditions in India.

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

Bangalore, 560001, India

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Type 2 diabetes, including newly-diagnosed who have never received insulin or an insulin analogue before, at the discretion of the physician.

Exclusion criteria

  • Currently treated with NovoMix® 30
  • Subjects who are unlikely to comply with protocol requirements
  • Previously enrolled in this study
  • 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 30

Drug

Being an observational study, dose of NovoMix 30 will be according to treating physician's discretion

Other names: NovoMix® 30, BIAsp30

Primary outcomes

  1. Change in Quality of Life from baseline (using QoLD questionnaire)

    Time frame: From baseline to 26 weeks of treatment

Secondary outcomes

  1. Safety

    Time frame: After 26 weeks

  2. Efficacy

    Time frame: After 26 weeks

Sponsors and collaborators

Lead sponsor

Novo Nordisk A/S

Industry

Registry information

Official study title

A Multicentre, Open Label, Nonrandomised, Non- Interventional, A Multicentre, Open Label, Nonrandomised, Non- Interventional, Observational Study to Evaluate the Quality of Life and Clinical Outcomes in Subjects Using Biphasic Insulin Aspart 30 (NovoMix® 30) for the Treatment of Diabetes Mellitus

Acronym: IMPROVE Life

Important dates

Study start
2008
Primary completion
2009
Study completion
2009
First posted
Jun 12, 2008
Registry last updated
Oct 31, 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.

Related clinical trials

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