Comparison of Biphasic Insulin Aspart 70/30 Versus Insulin Glargine in Subjects With Type 2 Diabetes

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

Comparison of the Effect on Glycemic Control of Biphasic Insulin Aspart 70/30 Versus Insulin Glargine in Combination With Metformin in Subjects With Type 2 Diabetes

This trial is conducted in the United States of America (USA). The purpose of this study is to test whether Biphasic Insulin Aspart 70/30 twice a day with Metformin improves glycemic control vs. once daily Insulin Glargine with Metformin in subjects with Type 2 Diabetes who are inadequately controlled on basal insulin plus oral anti-diabetic therapy.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

293

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

  • Puerto Rico
      • Manati, Puerto Rico, 00674
        • Novo Nordisk Investigational Site
      • Santurce, Puerto Rico, 00907
        • Novo Nordisk Investigational Site
  • United States
    • Alabama
      • Birmingham, Alabama, United States, 35235
        • Novo Nordisk Investigational Site
      • Tuscaloosa, Alabama, United States, 35406
        • Novo Nordisk Investigational Site
      • Vestavia, Alabama, United States, 35209
        • Novo Nordisk Investigational Site
    • Arkansas
      • Searcy, Arkansas, United States, 72143
        • Novo Nordisk Investigational Site
    • California
      • Chula Vista, California, United States, 91911
        • Novo Nordisk Investigational Site
      • Fullerton, California, United States, 92835
        • Novo Nordisk Investigational Site
      • Orange, California, United States, 92869
        • Novo Nordisk Investigational Site
      • Orange, California, United States, 92868
        • Novo Nordisk Investigational Site
    • Connecticut
      • New Britain, Connecticut, United States, 06050
        • Novo Nordisk Investigational Site
    • Florida
      • Aventura, Florida, United States, 33180
        • Novo Nordisk Investigational Site
      • Chiefland, Florida, United States, 32626
        • Novo Nordisk Investigational Site
      • Fort Myers, Florida, United States, 33907
        • Novo Nordisk Investigational Site
      • Jacksonville, Florida, United States, 32208
        • Novo Nordisk Investigational Site
      • Melbourne, Florida, United States, 32901
        • Novo Nordisk Investigational Site
      • Ocala, Florida, United States, 34471
        • Novo Nordisk Investigational Site
      • Plantation, Florida, United States, 33324
        • Novo Nordisk Investigational Site
    • Georgia
      • Atlanta, Georgia, United States, 30339
        • Novo Nordisk Investigational Site
      • Atlanta, Georgia, United States, 30303
        • Novo Nordisk Investigational Site
    • Idaho
      • Boise, Idaho, United States, 83702
        • Novo Nordisk Investigational Site
    • Illinois
      • Chicago, Illinois, United States, 60607
        • Novo Nordisk Investigational Site
    • Indiana
      • New Albany, Indiana, United States, 47150
        • Novo Nordisk Investigational Site
    • Iowa
      • Des Moines, Iowa, United States, 50314
        • Novo Nordisk Investigational Site
    • Kansas
      • Overland Park, Kansas, United States, 66209
        • Novo Nordisk Investigational Site
      • Topeka, Kansas, United States, 66606
        • Novo Nordisk Investigational Site
    • Louisiana
      • Baton Rouge, Louisiana, United States, 70808
        • Novo Nordisk Investigational Site
    • Maryland
      • Baltimore, Maryland, United States, 21204
        • Novo Nordisk Investigational Site
    • Massachusetts
      • Springfield, Massachusetts, United States, 01107
        • Novo Nordisk Investigational Site
    • Missouri
      • Chesterfield, Missouri, United States, 63017
        • Novo Nordisk Investigational Site
      • St. Louis, Missouri, United States, 63141
        • Novo Nordisk Investigational Site
      • St. Louis, Missouri, United States, 63017
        • Novo Nordisk Investigational Site
    • Nebraska
      • Omaha, Nebraska, United States, 68114
        • Novo Nordisk Investigational Site
    • Nevada
      • Las Vegas, Nevada, United States, 89119-6100
        • Novo Nordisk Investigational Site
    • New Jersey
      • Cherry Hill, New Jersey, United States, 08034
        • Novo Nordisk Investigational Site
      • Lawrenceville, New Jersey, United States, 08648
        • Novo Nordisk Investigational Site
      • Plainsboro, New Jersey, United States, 08536
        • Novo Nordisk Investigational Site
    • New York
      • New Hyde Park, New York, United States, 11042
        • Novo Nordisk Investigational Site
      • Staten Island, New York, United States, 10305
        • Novo Nordisk Investigational Site
      • Syracuse, New York, United States, 13210
        • Novo Nordisk Investigational Site
    • North Carolina
      • Greensboro, North Carolina, United States, 27408
        • Novo Nordisk Investigational Site
    • Ohio
      • Dayton, Ohio, United States, 45439
        • Novo Nordisk Investigational Site
      • Dayton, Ohio, United States, 45406
        • Novo Nordisk Investigational Site
      • Kettering, Ohio, United States, 45429
        • Novo Nordisk Investigational Site
    • Oklahoma
      • Clinton, Oklahoma, United States, 73601
        • Novo Nordisk Investigational Site
      • Tulsa, Oklahoma, United States, 74104
        • Novo Nordisk Investigational Site
    • Oregon
      • Eugene, Oregon, United States, 97401
        • Novo Nordisk Investigational Site
      • Portland, Oregon, United States, 97239
        • Novo Nordisk Investigational Site
      • Salem, Oregon, United States, 97302
        • Novo Nordisk Investigational Site
    • Pennsylvania
      • Lancaster, Pennsylvania, United States, 17601
        • Novo Nordisk Investigational Site
      • Melrose Park, Pennsylvania, United States, 19027
        • Novo Nordisk Investigational Site
      • Norristown, Pennsylvania, United States, 19401
        • Novo Nordisk Investigational Site
      • West Reading, Pennsylvania, United States, 19611
        • Novo Nordisk Investigational Site
    • South Carolina
      • Greer, South Carolina, United States, 29651
        • Novo Nordisk Investigational Site
    • Tennessee
      • Memphis, Tennessee, United States, 38115
        • Novo Nordisk Investigational Site
    • Texas
      • Arlington, Texas, United States, 76014
        • Novo Nordisk Investigational Site
      • Dallas, Texas, United States, 75230
        • Novo Nordisk Investigational Site
      • Dallas, Texas, United States, 75231
        • Novo Nordisk Investigational Site
      • Dallas, Texas, United States, 75390-8858
        • Novo Nordisk Investigational Site
      • Dallas, Texas, United States, 75246
        • Novo Nordisk Investigational Site
      • Dallas, Texas, United States, 75208
        • Novo Nordisk Investigational Site
      • Houston, Texas, United States, 77030
        • Novo Nordisk Investigational Site
      • Lewisville, Texas, United States, 75067
        • Novo Nordisk Investigational Site
      • Midland, Texas, United States, 79707
        • Novo Nordisk Investigational Site
      • Plano, Texas, United States, 75093
        • Novo Nordisk Investigational Site
      • Plano, Texas, United States, 75074
        • Novo Nordisk Investigational Site
      • San Antonio, Texas, United States, 78229
        • Novo Nordisk Investigational Site
    • Utah
      • Ogden, Utah, United States, 84403
        • Novo Nordisk Investigational Site
    • Virginia
      • Newport News, Virginia, United States, 23606
        • Novo Nordisk Investigational Site
      • Richmond, Virginia, United States, 23249
        • Novo Nordisk Investigational Site
      • Warrenton, Virginia, United States, 20186
        • Novo Nordisk Investigational Site
    • Washington
      • Bellevue, Washington, United States, 98004
        • 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

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 24 weeks
After 24 weeks

Secondary Outcome Measures

Outcome Measure
safety variables
other glycemic variables
8-point plasma glucose profile

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

January 1, 2005

Primary Completion (Actual)

November 1, 2006

Study Completion (Actual)

November 1, 2006

Study Registration Dates

First Submitted

November 30, 2004

First Submitted That Met QC Criteria

November 30, 2004

First Posted (Estimate)

December 1, 2004

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

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • BIASP-2191

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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