Efficacy and Safety of Semaglutide Versus Canagliflozin 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:12/8/2018
Start Date:March 15, 2017
End Date:November 16, 2018

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This trial is conducted in Africa, Asia, Europe, North and South America. The aim of the
trial is to compare the effect of once-weekly (OW) dosing of subcutaneous semaglutide (1.0
mg) versus once-daily dosing of oral canagliflozin (300 mg) on glycaemic control in subjects
with type 2 diabetes (T2D) on a background treatment of metformin


Inclusion Criteria: - Informed consent obtained before any trial-related activities.
Trial-related activities are any procedures that are carried out as part of the trial,
including activities to determine suitability for the trial - Male or female, age equal to
or above18 years at the time of signing informed consent - Diagnosed with type 2 diabetes
mellitus (T2D) - HbA1c of 7.0-10.5% (53-91 mmol/mol, both inclusive) - Stable daily dose of
metformin (equal to or above1500 mg or maximum tolerated dose as documented in the subject
medical record and in compliance with current local label) for at least 90 days prior to
the day of screening Exclusion Criteria: - Known or suspected hypersensitivity to trial
product(s) or related products - Previous participation in this trial. Participation is
defined as signed informed consent - 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 measure as required by local regulation or practice) -
Participation in any clinical trial of an approved or non-approved investigational
medicinal product within 90 days prior to the day of screening - Any disorder which in the
investigator's opinion might jeopardise subject's safety or compliance with the protocol -
Subject with alanine aminotransferase (ALT) above 2.5 x upper normal limit (UNL) - Family
or personal history of multiple endocrine neoplasia type 2 or medullary thyroid carcinoma.
Family is defined as a first degree relative - History or presence of pancreatitis (acute
or chronic) - History of diabetic ketoacidosis (DKA) - Any of the following: myocardial
infarction (MI), stroke, hospitalization for unstable angina or transient ischaemic attack
within the past 180 days prior to the day of screening - Subjects presently classified as
being in New York Heart Association (NYHA) Class IV - Planned coronary, carotid or
peripheral artery revascularisation known on the day of screening - Renal impairment
measured as eGFR below 60 ml/min/1.73 m^2 as defined by Kidney Disease Improving global
outcomes (KDIGO 2012) classification using isotope dilution mass spectrometry (IDMS) for
serum creatinine measured at screening - Treatment with any medication for the indication
of diabetes or obesity other than stated in the inclusion criteria within the past 90 days
prior to the day of screening. However, short term insulin treatment for a maximum of 14
days prior to the day of screening is allowed - Proliferative retinopathy or maculopathy
requiring acute treatment. Verified by fundus photography or dilated fundoscopy performed
within the past 90 days prior to randomisation - Presence or history of malignant neoplasms
within the past 5 years prior to the day of screening. Basal and squamous cell skin cancer
and any carcinoma in-situ is allowed - Medical history of diabetes-related lower limb
amputations or signs of critical lower limb ischemia, (e.g. skin ulcer, osteomyelitis, or
gangrene) within the last 26 weeks prior to screening
We found this trial at
47
sites
Meridian, Idaho 83646
1727
mi
from 43215
Meridian, ID
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Amarillo, Texas 79106
1078
mi
from 43215
Amarillo, TX
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Anaheim, California 92801
1962
mi
from 43215
Anaheim, CA
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Anderson, South Carolina 29621
377
mi
from 43215
Anderson, SC
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Baltimore, Maryland 21229
340
mi
from 43215
Baltimore, MD
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Brooklyn, New York 11215
280
mi
from 43215
Brooklyn, NY
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?
mi
from 43215
Buenos Aires,
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Cincinnati, Ohio 45229
95
mi
from 43215
Cincinnati, OH
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Conyers, Georgia 30094
438
mi
from 43215
Conyers, GA
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Corpus Christi, Texas 78404
1174
mi
from 43215
Corpus Christi, TX
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Corvallis, Oregon 97330
2060
mi
from 43215
Corvallis, OR
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Council Bluffs, Iowa 51501
678
mi
from 43215
Council Bluffs, IA
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Dallas, Texas 75231
905
mi
from 43215
Dallas, TX
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Detroit, Michigan 48201
163
mi
from 43215
Detroit, MI
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Fleming Island, Florida 32003
686
mi
from 43215
Fleming Island, FL
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Flint, Michigan 48504
213
mi
from 43215
Flint, MI
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Greensboro, North Carolina 27408
321
mi
from 43215
Greensboro, NC
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Hallandale Beach, Florida 33009
980
mi
from 43215
Hallandale Beach, FL
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Herndon, Virginia 20171
308
mi
from 43215
Herndon, VA
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Hialeah, Florida 33012
987
mi
from 43215
Hialeah, FL
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Houston, Texas 77030
995
mi
from 43215
Houston, TX
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Hyattsville, Maryland 20782
331
mi
from 43215
Hyattsville, MD
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1008
mi
from 43215
Katy, TX
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La Mesa, California 91942
1942
mi
from 43215
La Mesa, CA
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Lake Charles, Louisiana 70601
885
mi
from 43215
Lake Charles, LA
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Lexington, Kentucky 40503
157
mi
from 43215
Lexington, KY
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Los Angeles, California 90027
1973
mi
from 43215
Los Angeles, CA
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Marietta, Georgia 30060
423
mi
from 43215
Marietta, GA
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115
mi
from 43215
Maumee, OH
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Metairie, Louisiana 70002
796
mi
from 43215
Metairie, LA
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Miami, Florida 33136
992
mi
from 43215
Miami, FL
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Montclair, California 91763
1942
mi
from 43215
Montclair, CA
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New Windsor, New York 12553
482
mi
from 43215
New Windsor, NY
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Olympia, Washington 98502
2033
mi
from 43215
Olympia, WA
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Saint George, Utah 84790
1655
mi
from 43215
Saint George, UT
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San Antonio, Texas 78224
1138
mi
from 43215
San Antonio, TX
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San Diego, California 92111
1951
mi
from 43215
San Diego, CA
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Splendora, Texas 77372
958
mi
from 43215
Splendora, TX
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Spring Hill, Florida 34609
700
mi
from 43215
Spring Hill, FL
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Spring Valley, California 91978
2014
mi
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Spring Valley, CA
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Sterling Heights, Michigan 48310
180
mi
from 43215
Sterling Heights, MI
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117
mi
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Toledo, OH
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Trenton, New Jersey 08611
437
mi
from 43215
Trenton, NJ
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Troy, Michigan 48098
303
mi
from 43215
Troy, MI
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Tustin, California 92780
1957
mi
from 43215
Tustin, CA
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Walnut Creek, California 94598
2084
mi
from 43215
Walnut Creek, CA
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Wenatchee, Washington 98801
1912
mi
from 43215
Wenatchee, WA
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