Observational Study to Assess the Quality of Life and Clinical Outcomes in Subjects Using NovoMix® 30 for the Treatment of Diabetes
- Registration Number
- NCT00696163
- Lead Sponsor
- Novo Nordisk A/S
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 24975
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
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description A biphasic insulin aspart 30 -
- Primary Outcome Measures
Name Time Method Change in Quality of Life from baseline (using QoLD questionnaire) From baseline to 26 weeks of treatment
- Secondary Outcome Measures
Name Time Method Efficacy After 26 weeks Safety After 26 weeks
Trial Locations
- Locations (1)
Novo Nordisk Investigational Site
🇮🇳Bangalore, India