Efficacy and Safety of Semaglutide Versus Dulaglutide as add-on to Metformin in Subjects With Type 2 Diabetes.



Status:Completed
Conditions:Diabetes, Diabetes
Therapuetic Areas:Endocrinology
Healthy:No
Age Range:18 - Any
Updated:3/28/2019
Start Date:January 6, 2016
End Date:May 19, 2017

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Efficacy and Safety of Semaglutide Versus Dulaglutide as add-on to Metformin in Subjects With Type 2 Diabetes

This trial is conducted in Asia, Europe and the United States of America (USA). The aim of
the trial is to investigate efficacy and safety of semaglutide versus dulaglutide as add-on
to metformin in subjects with type 2 diabetes.


Inclusion Criteria: - Male or female, age at least 18 years at the time of signing informed
consent. - HbA1c (glycosylated haemoglobin) 7.0 - 10.5% (53 - 91 mmol/mol) (both inclusive)
- Subjects on stable diabetes treatment with metformin (minimum of 1500 mg/day or maximal
tolerated dose documented in the patient medical record) for 90 days prior to screening
Exclusion Criteria: - Female who is pregnant, breast-feeding or intends to become pregnant
or is of child-bearing potential and not using an adequate contraceptive method (adequate
contraceptive measures as required by local regulation or practice) - Any condition, which
in the investigator's opinion might jeopardise subject's safety or compliance with the
protocol - Treatment with any medication for the indication of diabetes or obesity other
than stated in the inclusion criteria in a period of 90 days before screening. An exception
is short-term insulin treatment for acute illness for a total of equal to or below 14 days
- History of pancreatitis (acute or chronic) - Screening calcitonin equal to or above 50
ng/L - Family or personal history of Multiple Endocrine Neoplasia Type 2 or Medullary
Thyroid Carcinoma - Renal impairment defined as eGFR (electronic case report form) below 60
mL/min/1.73 m^2 as per CKD-EPI (Chronic Kidney Disease Epidemiology Collaboration) -
Subjects presently classified as being in New York Heart Association Class IV - Planned
coronary, carotid or peripheral artery revascularisation on the day of screening -
Proliferative retinopathy or maculopathy requiring acute treatment - History or presence of
malignant neoplasms within the last 5 years (except basal and squamous cell skin cancer and
in-situ carcinomas) - Anticipated initiation or change in concomitant medications (for more
than 14 consecutive days or on a frequent basis) known to affect weight or glucose
metabolism (e.g. orlistat, thyroid hormones, corticosteroids)
We found this trial at
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Humboldt, Tennessee 38343
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Adairsville, Georgia 30103
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Addison, Illinois 60101
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Anaheim, California 92801
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Arlington, Texas 76012
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Atlanta, Georgia 30318
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Avon, Indiana 46123
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Bainbridge, Georgia 39819
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Carlsbad, California 92008
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Chandler, Arizona 85224
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Chicago, Illinois 60612
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Cincinnati, Ohio 45229
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Clearwater, Florida 33756
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Concord, California 94520
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Conyers, Georgia 30094
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Coral Gables, Florida 33134
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Corpus Christi, Texas 78404
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Corvallis, Oregon 97330
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Covington, Kentucky 41011
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Dallas, Texas 75231
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1956
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Denver, Colorado 80220
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Edgewater, Florida 32132
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Evansville, Indiana 47714
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Fleetwood, Pennsylvania 19522
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Fort Lauderdale, Florida 33316
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Garner, North Carolina 27529
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Gillespie, Illinois 62033
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Greenfield, Indiana 46140
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Greer, South Carolina 29651
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Gurnee, Illinois 60031
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Harleysville, Pennsylvania 19438
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Hawaiian Gardens, California 90716
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Houston, Texas 77030
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Huntington Park, California 90255
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Hyattsville, Maryland 20782
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Indianapolis, Indiana 46260
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Marietta, Georgia 30060
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Meridian, Idaho 83646
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Methuen, Massachusetts 01844
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Missoula, Montana 59808
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Moncks Corner, South Carolina 29461
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Montclair, California 91763
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Muncie, Indiana 47304
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Newton, Kansas 67114
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Norwalk, Connecticut 06851
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Orlando, Florida 32804
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Owensboro, Kentucky 42303
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Park City, Kansas 67219
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Pembroke Pines, Florida 33026
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Peoria, Illinois 61615
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Port Gibson, Mississippi 39150
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Port Orange, Florida 32127
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Riverside, California 92506
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Rochester, Michigan 48307
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Saint George, Utah 84790
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Spartanburg, South Carolina 29303
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Spokane, Washington 99202
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Sugar Land, Texas 77479
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Suwanee, Georgia 30024
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Tampa, Florida 33612
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Trenton, New Jersey 08611
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Tulsa, Oklahoma 74135
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Tuscumbia, Alabama 35674
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Wadsworth, Ohio 44281
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Whiteville, North Carolina 28472
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