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

Sponsored by:	Novo Nordisk
Information provided by:	Novo Nordisk
ClinicalTrials.gov Identifier:	NCT00696163

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 Mellitus	Drug: biphasic insulin aspart 30

MedlinePlus related topics: Diabetes

Drug Information available for: Insulin Insulin aspart

U.S. FDA Resources

Study Type:	Observational
Study Design:	Case-Only, Prospective
Official Title:	Observational Study to Evaluate the Quality of Life and Clinical Outcomes in Subjects Using NovoMix® 30 (Biphasic Insulin Aspart 30) for the Treatment of Diabetes Mellitus

Further study details as provided by Novo Nordisk:

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 ]

Biospecimen Retention: None Retained

Biospecimen Description:

Estimated Enrollment:	30000
Study Start Date:	April 2008
Estimated Study Completion Date:	January 2009
Estimated Primary Completion Date:	January 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

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

Investigators

Study Director:

Anil Shinde, MD

Novo Nordisk

More Information

Clinical Trials at Novo Nordisk This link exits the ClinicalTrials.gov site

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

Study placed in the following topic categories:

Metabolic Diseases
Insulin, Asp(B28)-
Diabetes Mellitus
Quality of Life
Endocrine System Diseases

Endocrinopathy
Metabolic disorder
Glucose Metabolism Disorders
Insulin

Additional relevant MeSH terms:

Hypoglycemic Agents
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 15, 2009