Glycaemic Control and Quality of Care in Type 2 Diabetes on NovoMix® 30 Previously Treated With Mixtard® Insulins - Full Text View

Sponsored by:	Novo Nordisk
Information provided by:	Novo Nordisk
ClinicalTrials.gov Identifier:	NCT00657319

Purpose

This observational study is conducted in Europe.

The objective of this retrospective observational cohort analysis is to assess the changes of glycaemic control and quality of care in those Type 2 diabetic patients who were previously treated with Mixtard® insulins after 6 months of their switch to analog premix insulin NovoMix® 30 therapy.

Condition	Intervention
Diabetes Mellitus, Type 2	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:	Cohort, Retrospective
Official Title:	Glycaemic Control and Quality of Care in Type 2 Diabetes on NovoMix® 30 Previously Treated With Mixtard® Insulins

Further study details as provided by Novo Nordisk:

Primary Outcome Measures:

HbA1C [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

General conditions (reason of switch, BMI, selected laboratory parameters, quality of care) [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]

Biospecimen Retention: None Retained

Biospecimen Description:

Estimated Enrollment:	5000
Study Start Date:	October 2007
Study Completion Date:	April 2008
Primary Completion Date:	March 2008 (Final data collection date for primary outcome measure)

Groups/Cohorts	Assigned Interventions
A	Drug: biphasic insulin aspart 30 The observation is performed under normal clinical practice conditions without any additionally required diagnostic/therapeutic features. Physicians are allowed to decide the treatment regimen according to the medical standards.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No
Sampling Method:	Probability Sample

Study Population

Adult with type 2 diabetes mellitus on premix insulin treatment.

Criteria

Inclusion Criteria:

Subjects diagnosed with type 2 diabetes previously treated with BHI for at least 12 months
Analogue premix administration for the last 6 months

Exclusion Criteria:

Known or suspected allergy to insulin aspart
Newly diagnosed diabetes

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00657319

Locations

Hungary

Budapest, Hungary, H-1025

Sponsors and Collaborators

Novo Nordisk

Investigators

Study Director:

Peter Varnai, MD

Novo Nordisk Hungary Ltd.

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-1939
Study First Received:	April 8, 2008
Last Updated:	June 20, 2008
ClinicalTrials.gov Identifier:	NCT00657319
Health Authority:	Hungary: National Institute of Pharmacy

Study placed in the following topic categories:

Metabolic Diseases
Diabetes Mellitus, Type 2
Insulin, Asp(B28)-
Diabetes Mellitus
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 16, 2009