Efficacy and Safety of Semaglutide Once-weekly Versus Placebo in Drug-naïve Subjects With Type 2 Diabetes



Status:Completed
Conditions:Diabetes, Diabetes
Therapuetic Areas:Endocrinology
Healthy:No
Age Range:18 - Any
Updated:1/17/2019
Start Date:February 3, 2014
End Date:May 8, 2015

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This trial is conducted globally. The aim of this trial is to investigate efficacy and safety
of semaglutide once-weekly versus placebo in drug-naïve subjects with type 2 diabetes.
(SUSTAIN™ 1-Monotherapy).


Inclusion Criteria: - For Japan only: Male or female, age above or equal to 20 years at the
time of signing inform consent - Subjects diagnosed with type 2 diabetes and treated with
diet and exercise for at least 30 days before screening - HbA1c 7.0 - 10.0 % (53 - 86
mmol/mol) (both inclusive) Exclusion Criteria: - Female who is pregnant, breast-feeding or
intends to become pregnant or is of child-bearing potential and not using adequate
contraceptive method (adequate contraceptive measures as required by local regulation or
practice) throughout the trial including the 5 week follow-up period. United Kingdom:
Adequate contraceptive measures are defined as established use of oral, injected or
implanted hormonal methods of contraception, placement of an intrauterine device or
intrauterine system, barrier methods of contraception (condom or occlusive cap with
spermicidal foam/gel/film/cream/suppository), male sterilisation (where partner is sole
partner of subject), or true abstinence (when in line with preferred and usual lifestyle) -
Any chronic disorder or severe disease which, in the opinion of the investigator, might
jeopardise subject's safety or compliance with the protocol - Treatment with any glucose
lowering agent(s) in a period of 90 days prior to screening. An exception is short-term
treatment (no longer than 7 days in total) with insulin in connection with inter-current
illness - History of chronic or idiopathic acute pancreatitis - Screening calcitonin value
above or equal to 50 ng/L (pg/mL) - Personal or family history of medullary thyroid
carcinoma or multiple endocrine neoplasia syndrome type 2 (MEN 2) - Impaired renal function
defined as eGFR (estimated glomerular filtration rate ) below 30 mL/min/1.73 m^2 per
modification of diet in renal disease (MDRD) formula (4 variable version) - Acute coronary
or cerebrovascular event within 90 days before randomisation - Heart failure, New York
Heart Association class IV
We found this trial at
34
sites
Albuquerque, New Mexico 87102
1333
mi
from 43215
Albuquerque, NM
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Anniston, Alabama 36207
462
mi
from 43215
Anniston, AL
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Belvidere, New Jersey 07823
422
mi
from 43215
Belvidere, NJ
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Billings, Montana 59101
1344
mi
from 43215
Billings, MT
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Birmingham, Alabama 35215
481
mi
from 43215
Birmingham, AL
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Boynton Beach, Florida 33472
943
mi
from 43215
Boynton Beach, FL
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Brownsburg, Indiana 46112
179
mi
from 43215
Brownsburg, IN
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Charlotte, North Carolina 28277
348
mi
from 43215
Charlotte, NC
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Cincinnati, Ohio 45229
95
mi
from 43215
Cincinnati, OH
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Colorado Springs, Colorado 80910
1161
mi
from 43215
Colorado Springs, CO
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Dallas, Texas 75231
905
mi
from 43215
Dallas, TX
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Delaware, Ohio 43015
23
mi
from 43215
Delaware, OH
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Franklin, Indiana 46131
114
mi
from 43215
Franklin, IN
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Hawaiian Gardens, California 90716
1969
mi
from 43215
Hawaiian Gardens, CA
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Jacksonville, Florida 32207
672
mi
from 43215
Jacksonville, FL
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Levittown, Pennsylvania 19056
433
mi
from 43215
Levittown, PA
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Lexington, Kentucky 40503
157
mi
from 43215
Lexington, KY
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Lomita, California 90717
1982
mi
from 43215
Lomita, CA
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Los Angeles, California 90027
1973
mi
from 43215
Los Angeles, CA
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Miami, Florida 33136
992
mi
from 43215
Miami, FL
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Miami Lakes, Florida 33016
983
mi
from 43215
Miami Lakes, FL
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Montclair, California 91763
1942
mi
from 43215
Montclair, CA
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Northridge, California 91325
1981
mi
from 43215
Northridge, CA
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Olive Branch, Mississippi 38654
508
mi
from 43215
Olive Branch, MS
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Omaha, Nebraska 68114
682
mi
from 43215
Omaha, NE
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Pell City, Alabama 35128
476
mi
from 43215
Pell City, AL
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Pembroke Pines, Florida 33026
978
mi
from 43215
Pembroke Pines, FL
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Savannah, Georgia 31406
555
mi
from 43215
Savannah, GA
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1022
mi
from 43215
Sealy, TX
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Spartanburg, South Carolina 29303
351
mi
from 43215
Spartanburg, SC
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Sugar Land, Texas 77479
1009
mi
from 43215
Sugar Land, TX
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Vancouver, British Columbia
?
mi
from 43215
Vancouver,
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Whiteville, North Carolina 28472
455
mi
from 43215
Whiteville, NC
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Wichita, Kansas 67205
785
mi
from 43215
Wichita, KS
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