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

This study has been completed.
Sponsor:
Information provided by:
Novo Nordisk
ClinicalTrials.gov Identifier:
NCT00696163
First received: June 10, 2008
Last updated: May 24, 2012
Last verified: May 2012
History of Changes

June 10, 2008
May 24, 2012
April 2008
March 2009   (final data collection date for primary outcome measure)
Change in Quality of Life from baseline (using QoLD questionnaire) [ Time Frame: From baseline to 26 weeks of treatment ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00696163 on ClinicalTrials.gov Archive Site
  • Safety [ Time Frame: After 26 weeks ] [ Designated as safety issue: Yes ]
  • Efficacy [ Time Frame: After 26 weeks ] [ Designated as safety issue: Yes ]
Same as current
Not Provided
Not Provided
 
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

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.
Not Provided
Observational
Observational Model: Case-Only
Time Perspective: Prospective
Not Provided
Not Provided
Probability Sample

Type 2 diabetes
  • Diabetes
  • Diabetes Mellitus, Type 2
Drug: biphasic insulin aspart 30
Being an observational study, dose of NovoMix 30 will be according to treating physician's discretion
Other Names:
  • NovoMix® 30
  • BIAsp30
A
Intervention: Drug: biphasic insulin aspart 30
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
23684
March 2009
March 2009   (final data collection date for primary outcome measure)

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
Both
Not Provided
No
Contact information is only displayed when the study is recruiting subjects
India
 
NCT00696163
BIASP-3555
No
Public Access to Clinical Trials, Novo Nordisk A/S
Novo Nordisk
Not Provided
Study Director: Anil Shinde, MD Novo Nordisk
Novo Nordisk
May 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP