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
Omaha, Nebraska 68114
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Omaha, NE
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Albuquerque, New Mexico 87102
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Albuquerque, NM
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Anniston, Alabama 36207
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Anniston, AL
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Belvidere, New Jersey 07823
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Belvidere, NJ
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Billings, Montana 59101
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Billings, MT
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Birmingham, Alabama 35215
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Birmingham, AL
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Boynton Beach, Florida 33472
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Boynton Beach, FL
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Brownsburg, Indiana 46112
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Brownsburg, IN
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Charlotte, North Carolina 28277
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Charlotte, NC
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Cincinnati, Ohio 45229
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Cincinnati, OH
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Colorado Springs, Colorado 80910
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Colorado Springs, CO
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Dallas, Texas 75231
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Dallas, TX
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Delaware, Ohio 43015
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Delaware, OH
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Franklin, Indiana 46131
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Franklin, IN
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Hawaiian Gardens, California 90716
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Hawaiian Gardens, CA
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Jacksonville, Florida 32207
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Jacksonville, FL
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Levittown, Pennsylvania 19056
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Levittown, PA
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Lexington, Kentucky 40503
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Lexington, KY
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Lomita, California 90717
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Lomita, CA
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Los Angeles, California 90027
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Los Angeles, CA
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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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Miami Lakes, FL
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Montclair, California 91763
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Montclair, CA
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Northridge, California 91325
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Northridge, CA
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Olive Branch, Mississippi 38654
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Olive Branch, MS
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Pell City, Alabama 35128
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Pell City, AL
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Pembroke Pines, Florida 33026
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Pembroke Pines, FL
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Savannah, Georgia 31406
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Savannah, GA
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Sealy, TX
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Spartanburg, South Carolina 29303
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Spartanburg, SC
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Sugar Land, Texas 77479
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Sugar Land, TX
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Vancouver, British Columbia
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Vancouver,
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Whiteville, North Carolina 28472
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Whiteville, NC
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Wichita, Kansas 67205
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Wichita, KS
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