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

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ClinicalTrials.gov Identifier: NCT00659282
Recruitment Status : Completed
First Posted : April 16, 2008
Last Update Posted : January 12, 2018
Sponsor:
Information provided by (Responsible Party):
Novo Nordisk A/S

Study Description
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Brief Summary:
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 or disease Intervention/treatment
Diabetes Diabetes Mellitus, Type 2 Drug: biphasic insulin aspart

Study Design
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Study Type : Observational
Actual Enrollment : 57610 participants
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
Actual Study Start Date : September 11, 2006
Actual Primary Completion Date : November 15, 2008
Actual Study Completion Date : November 15, 2008

Resource links provided by the National Library of Medicine


Groups and Cohorts
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Group/Cohort Intervention/treatment
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


Outcome Measures
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Primary Outcome Measures :
  1. Incidence of major hypoglycaemic events reported as serious adverse drug reactions [ Time Frame: during treatment ]

Eligibility Criteria
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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00659282


Locations
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Canada
Novo Nordisk Investigational Site
Mississauga, Canada, L4W 4XI
China, Beijing
Novo Nordisk Investigational Site
Beijing, Beijing, China, 100004
Greece
Novo Nordisk Investigational Site
Vouliagment, Greece, 16671
India
Novo Nordisk Investigational Site
Bangalore, India, 560001
Iran, Islamic Republic of
Novo Nordisk Investigational Site
Teheran, Iran, Islamic Republic of
Italy
Novo Nordisk Investigational Site
Rome, Italy, 00144
Japan
Novo Nordisk Investigational Site
Tokyo, Japan, 1000005
Korea, Republic of
Novo Nordisk Investigational Site
Seoul, Korea, Republic of, 137-920
Poland
Novo Nordisk Investigational Site
Warszawa, Poland, PL-02-274
Russian Federation
Novo Nordisk Investigational Site
Moscow, Russian Federation, 119330
Saudi Arabia
Novo Nordisk Investigational Site
Riyadh, Saudi Arabia, 3542
Sponsors and Collaborators
Novo Nordisk A/S
Investigators
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Study Director: Global Clinical Registry (GCR, 1452) Novo Nordisk A/S
More Information
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Additional Information:
Clinical Trials at Novo Nordisk  This link exits the ClinicalTrials.gov site

Publications of Results:

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Responsible Party: Novo Nordisk A/S
ClinicalTrials.gov Identifier: NCT00659282     History of Changes
Other Study ID Numbers: BIASP-1766
First Posted: April 16, 2008    Key Record Dates
Last Update Posted: January 12, 2018
Last Verified: January 2018
Additional relevant MeSH terms:
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Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Insulin
Insulin, Globin Zinc
Insulin Aspart
 Insulin, Long-Acting
Insulin degludec, insulin aspart drug combination
Biphasic Insulins
Insulin aspart, insulin aspart protamine drug combination 30:70
Insulin, Isophane
Hypoglycemic Agents
Physiological Effects of Drugs