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

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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT00696163

Acronym

IMPROVE Life

Enrollment

24975

Registered

2008-06-12

Start date

2008-04-30

Completion date

2009-03-31

Last updated

2016-10-31

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Diabetes, Diabetes Mellitus, Type 2

Brief summary

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.

Interventions

DRUGbiphasic insulin aspart 30

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

Study design

Observational model

CASE_ONLY

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
Change in Quality of Life from baseline (using QoLD questionnaire)	From baseline to 26 weeks of treatment

Secondary

Measure	Time frame
Safety	After 26 weeks
Efficacy	After 26 weeks

Countries

India

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026