Efficacy and Safety of Biphasic Insulin Aspart 30 in Type 1 or 2 Diabetes

February 22, 2017 updated by: Novo Nordisk A/S

A Multi-centre, Randomised, Parallel, Open Labelled Study to Compare the Efficacy and Safety Profile of Biphasic Insulin Aspart 30 (BIAsp 30) and Biphasic Human Insulin 30/70 (BHI 30/70) in Chinese Type 1 and 2 Diabetics

This trial is conducted in Asia. The aim of this trial is to investigate the efficacy of biphasic insulin aspart 30 on postprandial glycaemic control.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

219

Phase

  • Phase 3

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

  • China
      • Beijing, China, 100029
        • Novo Nordisk Investigational Site
    • Beijing
      • Beijing, Beijing, China, 100730
        • Novo Nordisk Investigational Site
      • Beijing, Beijing, China, 100853
        • Novo Nordisk Investigational Site
      • Beijing, Beijing, China, 100034
        • Novo Nordisk Investigational Site
    • Shanghai
      • Shanghai, Shanghai, China, 200433
        • Novo Nordisk Investigational Site
      • Shanghai, Shanghai, China, 200032
        • 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

18 years to 70 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Type 1 or 2 diabetes for at least 3 months
  • Stabilised on current treatment with premixed human insulin for at least 4 weeks
  • Body mass index (BMI) between 18-40 kg/m2
  • HbA1c below 13.0%
  • Able and willing to perform self-blood glucose monitoring

Exclusion Criteria:

  • The receipt of any investigational drug within the last three months prior to this trial
  • Has a history of drug abuse or alcohol dependence within the last 5 years
  • Active proliferative retinopathy requiring laser or surgical intervention within the last year
  • Recurrent major hypoglycaemia as judged by the Investigator
  • Known or suspected allergy to trial product or related product

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

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
2-hr postprandial plasma glucose (PPPG) excursion
Time Frame: after 12 weeks of treatment
after 12 weeks of treatment

Secondary Outcome Measures

Outcome Measure
HbA1c
Fasting plasma glucose

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.

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)

July 8, 2003

Primary Completion (ACTUAL)

November 26, 2003

Study Completion (ACTUAL)

November 26, 2003

Study Registration Dates

First Submitted

February 6, 2008

First Submitted That Met QC Criteria

February 6, 2008

First Posted (ESTIMATE)

February 18, 2008

Study Record Updates

Last Update Posted (ACTUAL)

February 24, 2017

Last Update Submitted That Met QC Criteria

February 22, 2017

Last Verified

February 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • BIASP-1536

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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