Observational Study of Safety and Effectiveness of NovoMix® 30 for the Treatment of Diabetes - Full Text View

Purpose

This study is conducted in Asia, Europe, Japan and North America.

The aim of this observational study is to evaluate the safety and effectiveness while using NovoMix® 30 during 26 weeks under normal clinical practice, in the countries participating in the study. The primary outcome is the incidence of major hypoglycaemic events reported as serious adverse drugs reaction conditions on hypoglycaemic events.

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

MedlinePlus related topics:

Diabetes

ChemIDplus related topics:

Insulin Insulin aspart

U.S. FDA Resources

Study Type:	Observational
Study Design:	Cohort, Prospective

Official Title:	Observational Study of Safety and Effectiveness of NovoMix® 30 (Biphasic Insulin Aspart) for the Treatment of Diabetes Mellitus

Further study details as provided by Novo Nordisk:

Primary Outcome Measures:

Incidence of major hypoglycaemic events reported as serious adverse drug reactions [ Time Frame: during treatment ] [ Designated as safety issue: Yes ]

Biospecimen Retention: None Retained

Biospecimen Description:

Estimated Enrollment:	55000
Study Start Date:	February 2006
Estimated Study Completion Date:	June 2009
Estimated Primary Completion Date:	June 2009 (Final data collection date for primary outcome measure)

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

Eligibility

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

Study Population

Patients from both general and speciality practice settings who have been deemed appropriate to receive NovoMix® 30 as new treatment and as part of routine out-patient care by the prescribing physician.

Criteria

Inclusion Criteria:

Age according to approved label and physician discretion
Type 2 diabetes including newly-diagnosed subjects who have never received insulin or an insulin analogue before

Exclusion Criteria:

Subjects who previously enrolled in this study
Subjects who are unlikely to comply with protocol requirements
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: NCT00659282

Locations


Canada

	Ottawa, Canada

China

	Beijing, China

Greece

	Athens, Greece

India

	New Delhi, India

Iran, Islamic Republic of

	Tehran, Iran, Islamic Republic of

Italy

	Rome, Italy

Japan

	Tokyo, Japan

Korea, Republic of

	Seoul, Korea, Republic of

Poland

	Warsaw, Poland

Russian Federation

	Moscow, Russian Federation

Saudi Arabia

	Riyadh, Saudi Arabia

Sponsors and Collaborators

Novo Nordisk

Investigators


Study Director:	Marta Anglada Planaguma	Novo Nordisk A/S

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-1766
First Received:	April 10, 2008
Last Updated:	September 11, 2008
ClinicalTrials.gov Identifier:	NCT00659282
Health Authority:	Canada: Health Canada; China: State Food and Drug Administration; India: Ministry of Health; Japan: Ministry of Health, Labor and Welfare; Saudi Arabia: Ministry of Health; South Korea: Korea Food and Drug Administration (KFDA); Greece: Ethics Committee; Iran: Ministry of Health; Italy: Ethics Committee; Poland: Ethics Committee; Russia: Federal Ethics Committee; Greece: Ministry of Health & Social Solidarity Nat. Org. for Medicines

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 October 17, 2008

Sponsored by:	Novo Nordisk
Information provided by:	Novo Nordisk
ClinicalTrials.gov Identifier:	NCT00659282