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

January 11, 2018 updated by: Novo Nordisk A/S

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

57610

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
      • Mississauga, Canada, L4W 4XI
        • Novo Nordisk Investigational Site
  • China
    • Beijing
      • Beijing, Beijing, China, 100004
        • Novo Nordisk Investigational Site
  • Greece
      • Vouliagment, Greece, 16671
        • Novo Nordisk Investigational Site
  • India
      • Bangalore, India, 560001
        • Novo Nordisk Investigational Site
  • Iran, Islamic Republic of
      • Teheran, Iran, Islamic Republic of
        • Novo Nordisk Investigational Site
  • Italy
      • Rome, Italy, 00144
        • Novo Nordisk Investigational Site
  • Japan
      • Tokyo, Japan, 1000005
        • Novo Nordisk Investigational Site
  • Korea, Republic of
      • Seoul, Korea, Republic of, 137-920
        • Novo Nordisk Investigational Site
  • Poland
      • Warszawa, Poland, PL-02-274
        • Novo Nordisk Investigational Site
  • Russian Federation
      • Moscow, Russian Federation, 119330
        • Novo Nordisk Investigational Site
  • Saudi Arabia
      • Riyadh, Saudi Arabia, 3542
        • Novo Nordisk Investigational Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Incidence of major hypoglycaemic events reported as serious adverse drug reactions
Time Frame: during treatment
during treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Novo Nordisk A/S

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 11, 2006

Primary Completion (Actual)

November 15, 2008

Study Completion (Actual)

November 15, 2008

Study Registration Dates

First Submitted

April 10, 2008

First Submitted That Met QC Criteria

April 10, 2008

First Posted (Estimate)

April 16, 2008

Study Record Updates

Last Update Posted (Actual)

January 12, 2018

Last Update Submitted That Met QC Criteria

January 11, 2018

Last Verified

January 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • BIASP-1766

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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