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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:
ClinicalTrials.gov Identifier:
NCT00696163
First Posted: June 12, 2008
Last Update Posted: October 31, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Novo Nordisk A/S
  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 ]

Secondary Outcome Measures:
  • Safety [ Time Frame: After 26 weeks ]
  • Efficacy [ Time Frame: After 26 weeks ]

Enrollment: 24975
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

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00696163


Locations
India
Novo Nordisk Investigational Site
Bangalore, India, 560001
Sponsors and Collaborators
Novo Nordisk A/S
Investigators
Study Director: Global Clinical Registry (GCR, 1452) Novo Nordisk A/S
  More Information

Additional Information:
Responsible Party: Novo Nordisk A/S
ClinicalTrials.gov Identifier: NCT00696163     History of Changes
Other Study ID Numbers: BIASP-3555
First Submitted: June 10, 2008
First Posted: June 12, 2008
Last Update Posted: October 31, 2016
Last Verified: October 2016

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Insulin aspart, insulin aspart protamine drug combination 30:70
Insulin
Insulin Aspart
Biphasic Insulins
Insulin, Isophane
Hypoglycemic Agents
Physiological Effects of Drugs