Efficacy and Safety of Biphasic Insulin Aspart 30 in Subjects With Type 2 Diabetes

January 10, 2017 updated by: Novo Nordisk A/S

Efficacy and Safety of Initiation of Biphasic Insulin Aspart 30 Treatment in Subjects With Type 2 Diabetes Mellitus Failing OAD Therapy

This trial is conducted in Asia. The aim of this trial is to investigate the efficacy and safety of biphasic insulin aspart 30 as start insulin in subjects with type 2 diabetes failing OAD therapy.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

193

Phase

  • Phase 4

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

  • Australia
      • Fitzroy, Australia, 3065
        • Novo Nordisk Investigational Site
      • Garran, Australia, 2605
        • Novo Nordisk Investigational Site
      • Stones Corner, Australia, 4120
        • Novo Nordisk Investigational Site
    • New South Wales
      • Blacktown, New South Wales, Australia, 2148
        • Novo Nordisk Investigational Site
      • Broadmeadow, New South Wales, Australia, 2292
        • Novo Nordisk Investigational Site
  • Hong Kong
      • Hong Kong Island, Hong Kong
        • Novo Nordisk Investigational Site
      • Shatin, New Territories, Hong Kong
        • Novo Nordisk Investigational Site
  • Malaysia
      • Cheras, Malaysia, 56000
        • Novo Nordisk Investigational Site
      • Georgetown, Penang, Malaysia, 10450
        • Novo Nordisk Investigational Site
      • Kota Bharu, Kelantan, Malaysia, 16150
        • Novo Nordisk Investigational Site
  • Philippines
      • Cebu City, Philippines, 6000
        • Novo Nordisk Investigational Site
      • Quezon City, Philippines, 1100
        • Novo Nordisk Investigational Site
  • Singapore
      • Singapore, Singapore, 159964
        • Novo Nordisk Investigational Site
  • Taiwan
      • Changhua, Taiwan, 500
        • Novo Nordisk Investigational Site
      • Kaoshiung, Taiwan, 807
        • Novo Nordisk Investigational Site
  • Thailand
      • Bangkok, Thailand, 10330
        • Novo Nordisk Investigational Site
      • Bangkok, Thailand, 10300
        • 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 and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Type 2 diabetes for at least 24 months
  • BMI between 18 and 30 kg/m2
  • Insulin naive subjects
  • OAD treatment with max two OADs alone or combined with other therapy
  • HbA1c between 7-12%

Exclusion Criteria:

  • Type 1 diabetes
  • Receipt of any investigational drug within the last three months prior to this trial
  • Current or previous treatment with thiazolidiones within the last 6 months
  • OAD treatment with three or more OADs within the last 4 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

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
HbA1c
Time Frame: after 11 weeks of treatment
after 11 weeks of treatment

Secondary Outcome Measures

Outcome Measure
Time Frame
The proportion of subjects achieving treatment target of HbA1c below 7%
Time Frame: at 11 and 24 weeks
at 11 and 24 weeks
8-point plasma glucose profiles
Time Frame: performed at 11 and 24 weeks
performed at 11 and 24 weeks
FPG
Time Frame: at 11 weeks and 24 weeks
at 11 weeks and 24 weeks

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

December 1, 2003

Primary Completion (Actual)

October 1, 2004

Study Completion (Actual)

October 1, 2004

Study Registration Dates

First Submitted

January 18, 2008

First Submitted That Met QC Criteria

January 18, 2008

First Posted (Estimate)

January 30, 2008

Study Record Updates

Last Update Posted (Estimate)

January 11, 2017

Last Update Submitted That Met QC Criteria

January 10, 2017

Last Verified

January 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • BIASP-3021

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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