A Trial Comparing the Efficacy, Patient-reported Outcomes and Safety of Insulin Degludec 200 U/mL vs Insulin Glargine in Subjects With Type 2 Diabetes Mellitus Requiring High-dose Insulin



Status:Completed
Conditions:Diabetes
Therapuetic Areas:Endocrinology
Healthy:No
Age Range:18 - Any
Updated:4/21/2016
Start Date:April 2012
End Date:January 2014

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Trial Summary
Trial Overview
Inclusion Criteria
This trial is conducted in the United States of America (USA). The aim of the trial is to
confirm the efficacy of IDeg (insulin degludec) versus IGlar (insulin glargine) in
controlling glycaemia. Subjects are to continue their pre-trial metformin treatment.


Inclusion Criteria:

- Type 2 diabetes

- Current treatment with once daily insulin glargine in vials with a daily dose equal
to or above 65 U and equal to or below 100 U

- Current treatment with a stable dose of metformin plus/minus one additional oral
antidiabetic drug (OAD) for at least 12 weeks

- Glycosylated haemoglobin (HbA1c) equal to or above 7.5%

Exclusion Criteria:

- Current treatment with insulin other than insulin glargine in vials

- Treatment with thiazolidinediones or glucagon-like peptide-1 (GLP-1) receptor
agonists within 12 weeks

- Stroke; heart failure; myocardial infarction; unstable angina pectoris; coronary
arterial bypass graft or angioplasty

- Suffer from cancer (except basal cell skin cancer and squamous-cell cancer)
We found this trial at
35
sites
Novo Nordisk Clinical Trial Call Center
Tacoma, Washington 98405
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Bradenton, Florida 34208
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Chattanooga, Tennessee 37404
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Dallas, Texas 75235
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Franklin, Ohio 45005
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Franklin, OH
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Fresno, California 93720
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Fresno, CA
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Greenbrae, California 94904
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Greenbrae, CA
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Greenville, North Carolina 27834
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Hialeah, Florida 33012
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Hialeah, FL
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Homestead, Florida 33030
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Homestead, FL
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Jacksonville, Florida 32216
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Jefferson City, Missouri 65109
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Jefferson City, MO
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Kettering, Ohio 45429
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Kettering, OH
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Kissimmee, Florida 34741
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Las Vegas, Nevada 89148
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Las Vegas, NV
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Lawrenceville, New Jersey 08648
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Lawrenceville, NJ
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Lexington, Kentucky 40503
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Lexington, KY
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Manati, 00674
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Manati,
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Mesa, Arizona 85202
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Metairie, Louisiana 70002
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Miami, Florida 33136
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Miami, FL
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Miami Lakes, Florida 33016
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Nashville, Tennessee 37232
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Northport, New York 11768
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Northport, NY
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Philadelphia, Pennsylvania 19107
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Rockville, Maryland 20852
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Rockville, MD
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Roswell, Georgia 30076
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Roswell, GA
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San Antonio, Texas 78229
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San Ramon, California 94583
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Schertz, Texas 78154
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Southfield, Michigan 48034
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St. Petersburg, Florida 33701
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Staten Island, New York 10301
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Sugar Land, Texas 77478
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Worcester, Massachusetts 01655
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Worcester, MA
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