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

This study has been completed.
Information provided by (Responsible Party):
Novo Nordisk A/S Identifier:
First received: April 10, 2008
Last updated: January 5, 2017
Last verified: January 2017
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 ]

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
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:
  • NovoMix 30
  • NovoLog Mix 70/30


Ages Eligible for Study:   Child, Adult, Senior
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.

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 identifier: NCT00659282

Novo Nordisk Investigational Site
Mississauga, Canada, L4W 4XI
China, Beijing
Novo Nordisk Investigational Site
Beijing, Beijing, China, 100004
Novo Nordisk Investigational Site
Vouliagment, Greece, 16671
Novo Nordisk Investigational Site
Bangalore, India, 560001
Iran, Islamic Republic of
Novo Nordisk Investigational Site
Teheran, Iran, Islamic Republic of
Novo Nordisk Investigational Site
Rome, Italy, 00144
Novo Nordisk Investigational Site
Tokyo, Japan, 1000005
Korea, Republic of
Novo Nordisk Investigational Site
Seoul, Korea, Republic of, 137-920
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
Study Director: Global Clinical Registry (GCR, 1452) Novo Nordisk A/S
  More Information

Additional Information:

Responsible Party: Novo Nordisk A/S Identifier: NCT00659282     History of Changes
Other Study ID Numbers: BIASP-1766
Study First Received: April 10, 2008
Last Updated: January 5, 2017

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Insulin, Globin Zinc
Insulin degludec, insulin aspart drug combination
Insulin aspart, insulin aspart protamine drug combination 30:70
Insulin Aspart
Insulin, Long-Acting
Biphasic Insulins
Insulin, Isophane
Hypoglycemic Agents
Physiological Effects of Drugs processed this record on July 19, 2017