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 A/S
ClinicalTrials.gov Identifier:
NCT00696163
First received: June 10, 2008
Last updated: May 24, 2012
Last verified: May 2012
  Purpose

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.


Condition Intervention
Diabetes
Diabetes Mellitus, Type 2
Drug: biphasic insulin aspart 30

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official 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

Resource links provided by NLM:


Further study details as provided by Novo Nordisk A/S:

Primary Outcome Measures:
  • Change in Quality of Life from baseline (using QoLD questionnaire) [ Time Frame: From baseline to 26 weeks of treatment ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Safety [ Time Frame: After 26 weeks ] [ Designated as safety issue: Yes ]
  • Efficacy [ Time Frame: After 26 weeks ] [ Designated as safety issue: Yes ]

Enrollment: 23684
Study Start Date: April 2008
Study Completion Date: March 2009
Primary Completion Date: March 2009 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
A 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

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

Type 2 diabetes

Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00696163

Locations
India
Bangalore, India, 560001
Sponsors and Collaborators
Novo Nordisk A/S
Investigators
Study Director: Anil Shinde, MD Novo Nordisk A/S
  More Information

Additional Information:
No publications provided

Responsible Party: Public Access to Clinical Trials, Novo Nordisk A/S
ClinicalTrials.gov Identifier: NCT00696163     History of Changes
Other Study ID Numbers: BIASP-3555
Study First Received: June 10, 2008
Last Updated: May 24, 2012
Health Authority: India: Ministry of Health

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Insulin aspart
Insulin
Insulin, NPH
Hypoglycemic Agents
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on April 16, 2014