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 Diabetes Mellitus, Type 2	Drug: biphasic insulin aspart

Study Type:	Observational
Study Design:	Observational Model: Cohort Time Perspective: Prospective
Official Title:	Observational Study of Safety and Effectiveness of NovoMix® 30 (Biphasic Insulin Aspart) for the Treatment of Diabetes Mellitus

Resource links provided by NLM:

MedlinePlus related topics: Diabetes Diabetes Medicines Diabetes Type 2

Drug Information available for: Insulin human Insulin aspart

U.S. FDA Resources

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 ]

Enrollment:	58223
Study Start Date:	September 2006
Study Completion Date:	November 2008
Primary Completion Date:	November 2008 (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. Other Names: BIASP NovoMix 30 NovoLog Mix 70/30

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:

Christoph Koenen, M.D.

Novo Nordisk

More Information

Additional Information:

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

No publications provided by Novo Nordisk

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Yang W, Gao Y, Liu G, Chen L, Fu Z, Zou D, Feng P, Zhao Z. Biphasic insulin aspart 30 as insulin initiation or replacement therapy: the China cohort of the IMPROVE study. Curr Med Res Opin. 2010 Jan;26(1):101-7.

Gumprecht J, Benroubi M, Borzi V, Kawamori R, Shaban J, Shah S, Shestakova M, Wenying Y, Ligthelm R, Valensi P; IMPROVE Study Group Expert Panel. Intensification to biphasic insulin aspart 30/70 (BIAsp 30, NovoMix 30) can improve glycaemic control in patients treated with basal insulins: a subgroup analysis of the IMPROVE observational study. Int J Clin Pract. 2009 Jun;63(6):966-72.

Valensi P, Benroubi M, Borzi V, Gumprecht J, Kawamori R, Shaban J, Shah S, Shestakova M, Wenying Y; IMPROVE Study Group Expert Panel. Initiating insulin therapy with, or switching existing insulin therapy to, biphasic insulin aspart 30/70 (NovoMix 30) in routine care: safety and effectiveness in patients with type 2 diabetes in the IMPROVE observational study. Int J Clin Pract. 2009 Mar;63(3):522-31. Epub 2009 Jan 27.

Responsible Party:	Novo Nordisk
ClinicalTrials.gov Identifier:	NCT00659282 History of Changes
Other Study ID Numbers:	BIASP-1766
Study First Received:	April 10, 2008
Last Updated:	June 15, 2012
Health Authority:	Canada: Health Canada China: 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 - National Organizaion for Medicines (EOF)

Additional relevant MeSH terms:

Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases

Insulin aspart
Insulin
Hypoglycemic Agents
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 19, 2013

Observational Study of Safety and Effectiveness of NovoMix® 30 for the Treatment of Diabetes (IMPROVE™)