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

This study has been completed.
Sponsor:
Information provided by:
Novo Nordisk A/S
ClinicalTrials.gov Identifier:
NCT00659282
First received: April 10, 2008
Last updated: August 11, 2014
Last verified: August 2014
  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:


Further study details as provided by Novo Nordisk A/S:

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

Enrollment: 57610
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00659282

Locations
Canada
Mississauga, Canada, L4W 4XI
China, Beijing
Beijing, Beijing, China, 100004
Greece
Vouliagment, Greece, 16671
India
Bangalore, India, 560001
Iran, Islamic Republic of
Teheran, Iran, Islamic Republic of
Italy
Rome, Italy, 00144
Japan
Tokyo, Japan, 1000005
Korea, Republic of
Seoul, Korea, Republic of, 137-920
Poland
Warszawa, Poland, PL-02-274
Russian Federation
Moscow, Russian Federation, 119330
Saudi Arabia
Riyadh, Saudi Arabia, 3542
Sponsors and Collaborators
Novo Nordisk A/S
Investigators
Study Director: Christoph Koenen, M.D. Novo Nordisk A/S
  More Information

Additional Information:
No publications provided by Novo Nordisk A/S

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
ClinicalTrials.gov Identifier: NCT00659282     History of Changes
Other Study ID Numbers: BIASP-1766
Study First Received: April 10, 2008
Last Updated: August 11, 2014
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
Endocrine System Diseases
Glucose Metabolism Disorders
Metabolic Diseases
Biphasic Insulins
Insulin
Insulin Aspart
Hypoglycemic Agents
Pharmacologic Actions
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on October 21, 2014