Comparison of Biphasic Insulin Aspart 70/30 With Anti-Diabetic Drugs in Subjects With Type 2 Diabetes

NCT ID: NCT00097279

Last Updated: 2017-01-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

230 participants

Study Classification

INTERVENTIONAL

Study Start Date

2004-08-31

Study Completion Date

2005-08-31

Brief Summary

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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 is a safe and at least as effective alternative in combination with two oral anti-diabetics compared to the two oral anti-diabetics alone for the control of blood glucose.

Detailed Description

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Conditions

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Diabetes Diabetes Mellitus, Type 2

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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biphasic insulin aspart

Intervention Type DRUG

pioglitazone

Intervention Type DRUG

metformin

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Subjects with type 2 diabetes mellitus
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Novo Nordisk A/S

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Global Clinical Registry (GCR, 1452)

Role: STUDY_DIRECTOR

Novo Nordisk A/S

Locations

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Novo Nordisk Investigational Site

Birmingham, Alabama, United States

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Glendale, Arizona, United States

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Phoenix, Arizona, United States

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Searcy, Arkansas, United States

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Burlingame, California, United States

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Chula Vista, California, United States

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Fullerton, California, United States

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Los Angeles, California, United States

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Redwood City, California, United States

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Denver, Colorado, United States

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New Britain, Connecticut, United States

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Newark, Delaware, United States

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Aventura, Florida, United States

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Fort Myers, Florida, United States

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Hollywood, Florida, United States

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Lake Mary, Florida, United States

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Melbourne, Florida, United States

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Ocala, Florida, United States

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Pembroke Pines, Florida, United States

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Tallahassee, Florida, United States

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West Palm Beach, Florida, United States

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Atlanta, Georgia, United States

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Columbus, Georgia, United States

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Savannah, Georgia, United States

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Boise, Idaho, United States

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Chicago, Illinois, United States

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Topeka, Kansas, United States

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Wichita, Kansas, United States

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Baton Rouge, Louisiana, United States

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Easton, Maryland, United States

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Danvers, Massachusetts, United States

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Salisbury, Massachusetts, United States

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Waltham, Massachusetts, United States

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Detroit, Michigan, United States

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Grand Rapids, Michigan, United States

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Livonia, Michigan, United States

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Saint Cloud, Minnesota, United States

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Columbia, Missouri, United States

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Las Vegas, Nevada, United States

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Reno, Nevada, United States

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Hampton, New Hampshire, United States

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Berlin, New Jersey, United States

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Turnersville, New Jersey, United States

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East Syracuse, New York, United States

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New York, New York, United States

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New York, New York, United States

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Greenville, North Carolina, United States

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Columbus, Ohio, United States

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Dayton, Ohio, United States

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Kettering, Ohio, United States

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Medford, Oregon, United States

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Melrose Park, Pennsylvania, United States

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Philadelphia, Pennsylvania, United States

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Greer, South Carolina, United States

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Chattanooga, Tennessee, United States

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Arlington, Texas, United States

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Dallas, Texas, United States

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Irving, Texas, United States

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Midland, Texas, United States

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San Antonio, Texas, United States

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Ogden, Utah, United States

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Newport News, Virginia, United States

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Norfolk, Virginia, United States

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Richmond, Virginia, United States

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Suffolk, Virginia, United States

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Warrenton, Virginia, United States

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Kirkland, Washington, United States

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Olympia, Washington, United States

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Renton, Washington, United States

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Tacoma, Washington, United States

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Milwaukee, Wisconsin, United States

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Countries

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United States

References

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Raskin P, Matfin G, Schwartz SL, Chaykin L, Chu PL, Braceras R, Wynne A. Addition of biphasic insulin aspart 30 to optimized metformin and pioglitazone treatment of type 2 diabetes mellitus: The ACTION Study (Achieving Control Through Insulin plus Oral ageNts). Diabetes Obes Metab. 2009 Jan;11(1):27-32. doi: 10.1111/j.1463-1326.2007.00796.x. Epub 2007 Oct 17.

Reference Type RESULT
PMID: 17941873 (View on PubMed)

Related Links

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http://novonordisk-trials.com

Clinical Trials at Novo Nordisk

Other Identifiers

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BIASP-2186

Identifier Type: -

Identifier Source: org_study_id

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