Efficacy of Biphasic Insulin Aspart 30 in Type 2 Diabetics Failing on OADs

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

NovoLog® Mix 70/30 (Biphasic Insulin Aspart 70/30) Titrate-To-Target: An Observational Study of the Efficacy of NovoLog® Mix 70/30 in Patients With Type 2 Diabetes Mellitus Not Achieving Glycemic Targets on OADs With / Without Once Daily Basal Insulin Therapy

This trial is conducted in the United States of America (USA). The aim of this trial is to investigate the effectiveness of biphasic insulin aspart 30 in type 2 diabetics not achieving blood sugar levels when treated with oral anti-diabetics drugs (OADs) with or without basal insulin therapy.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

102

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

  • United States
    • Arizona
      • Phoenix, Arizona, United States, 85006
        • Novo Nordisk Investigational Site
    • California
      • La Jolla, California, United States, 92093-0694
        • Novo Nordisk Investigational Site
      • La Jolla, California, United States, 92093-0831
        • Novo Nordisk Investigational Site
    • Florida
      • Deland, Florida, United States, 32720
        • Novo Nordisk Investigational Site
    • Kansas
      • Wichita, Kansas, United States, 67205
        • Novo Nordisk Investigational Site
    • Nebraska
      • Omaha, Nebraska, United States, 68114
        • Novo Nordisk Investigational Site
    • New York
      • Albany, New York, United States, 12206
        • Novo Nordisk Investigational Site
    • Ohio
      • Cleveland, Ohio, United States, 44115
        • Novo Nordisk Investigational Site
    • Oregon
      • Medford, Oregon, United States, 97504
        • Novo Nordisk Investigational Site
    • Tennessee
      • Memphis, Tennessee, United States, 38119
        • Novo Nordisk Investigational Site
    • Texas
      • Dallas, Texas, United States, 75231
        • Novo Nordisk Investigational Site
      • Houston, Texas, United States, 77030
        • Novo Nordisk Investigational Site
    • Utah
      • Ogden, Utah, United States, 84403
        • Novo Nordisk Investigational Site
    • Washington
      • Renton, Washington, United States, 98057
        • Novo Nordisk Investigational Site
    • Wisconsin
      • Milwaukee, Wisconsin, United States, 53209
        • 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 mellitus for at least 12 months
  • HbA1c: 7.5-10.0%
  • An antidiabetic regimen that has been stable for at least 3 months
  • Able and willing to perform SMBG testing as per protocol

Exclusion Criteria:

  • Use of any insulin preparations other than NPH or glargine within the past 6 months
  • Pregnancy, breastfeeding, intention to become pregnant within the next 12 months, or judged to be using inadequate contraceptive measures (adequate contraceptive measures includes: sterilization, intrauterine devices, oral contraceptives, or consistent use of barrier methods)
  • Known or suspected allergy to trial product or agents related to trial 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: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: A
Drug: biphasic insulin aspart 30
Treat-to-target dose titration scheme
Other Names:
  • BIASP
  • NovoMix®
  • NovoLog® Mix 70/30

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Percentage of subjects achieving HbA1c below 6.5%
Time Frame: after 16, 32 and 48 weeks, respectively
after 16, 32 and 48 weeks, respectively

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)

June 26, 2003

Primary Completion (Actual)

October 31, 2004

Study Completion (Actual)

November 29, 2004

Study Registration Dates

First Submitted

November 13, 2008

First Submitted That Met QC Criteria

November 14, 2008

First Posted (Estimate)

November 17, 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-2174

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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