Observational Study to Evaluate the Safety and Efficacy of NovoMix® 70 in Type 2 Diabetes - Full Text View

Sponsored by:	Novo Nordisk
Information provided by:	Novo Nordisk
ClinicalTrials.gov Identifier:	NCT00704223

Purpose

This study is conducted in Europe. The aim of this observational study is to evaluate the incidence of adverse events while using NovoMix® 70 under normal clinical practice conditions in Austria.

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

MedlinePlus related topics: Diabetes

Drug Information available for: Insulin Insulin aspart

U.S. FDA Resources

Study Type:	Observational
Study Design:	Cohort, Prospective
Official Title:	Observational Study on Safety and Efficacy in Subjects Using NovoMix® 70 (Biphasic Insulin Aspart) for Treatment of Type 2 Diabetes Mellitus

Further study details as provided by Novo Nordisk:

Primary Outcome Measures:

number of major and minor hypoglycaemic events and adverse events [ Time Frame: 3 months ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

HbA1c [ Time Frame: 3 months ] [ Designated as safety issue: No ]
PPBG [ Time Frame: 3 months ] [ Designated as safety issue: No ]
FBG [ Time Frame: 3 months ] [ Designated as safety issue: No ]

Biospecimen Retention: Samples With DNA

Biospecimen Description:

Blood sample

Enrollment:	581
Study Start Date:	May 2008
Study Completion Date:	October 2008
Primary Completion Date:	October 2008 (Final data collection date for primary outcome measure)

Groups/Cohorts	Assigned Interventions
A	Drug: biphasic insulin aspart Start dose and frequency to prescribed by the physician as a result of a normal clinical evaluation

Eligibility

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

Study Population

Male and female above 18 years with type 2 diabetes

Criteria

Inclusion Criteria:

Type 2 diabetes
HbA1c over 7%
No contraindication with NovoMix® 70

Exclusion Criteria:

Type 1 diabetes
Subjects participating in a clinical trial or another observational study
Subjects under previous basis-bolus insulin therapy
Women who are pregnant, breast feeding and women of child bearing capacity who are not using any reliable contraceptive method

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00704223

Locations

Austria

Wien, Austria, 1140

Sponsors and Collaborators

Novo Nordisk

Investigators

Study Director:

Angelika Duarte, MD

Novo Nordisk Pharma GmbH Austria

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-3576
Study First Received:	June 20, 2008
Last Updated:	November 6, 2008
ClinicalTrials.gov Identifier:	NCT00704223
Health Authority:	Austria: Not required for observational study in Austria

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