Efficacy and Safety of Semaglutide Once Weekly Versus Insulin Glargine Once Daily as add-on to Metformin With or Without Sulphonylurea in Insulin-naïve Subjects With Type 2 Diabetes



Status:Completed
Conditions:Diabetes, Diabetes
Therapuetic Areas:Endocrinology
Healthy:No
Age Range:18 - Any
Updated:4/17/2018
Start Date:August 4, 2014
End Date:September 3, 2015

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Efficacy and Safety of Semaglutide Once Weekly Versus Insulin Glargine Once Daily as Add on to Metformin With or Without Sulphonylurea in Insulin-naïve Subjects With Type 2 Diabetes

This trial is conducted in Africa, North and South America, Asia and Europe. The purpose of
the trial is to compare the effect of once-weekly dosing of two dose levels of semaglutide
versus insulin glargine once-daily on glycaemic control after 30 weeks of treatment in
insulin-naïve subjects with type 2 diabetes.


Inclusion Criteria:

- Male or female, 18 years or older at the time of signing informed consent

- Insulin-naïve subjects diagnosed with type 2 diabetes and on stable diabetes treatment
with metformin or metformin and SU (metformin 1500 mg or higher or maximum tolerated
dose and SU half of maximum allowed dose according to national label or higher) for at
least 90 days before screening. Stable is defined as unchanged medication and
unchanged dose

- 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 of
childbearing potential 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

- Any disorder which, in the opinion of the Investigator might jeopardise subject's
safety or compliance with the protocol

- Treatment with any glucose lowering agent(s) other than stated in the inclusion
criteria in a period of 90 days before screening. An exception is short-term treatment
(7 days or less in total) with insulin in connection with intercurrent illness

- History of chronic or idiopathic acute pancreatitis

- Screening calcitonin value greater than or equal to 50 ng/L

- Personal or family history of medullary thyroid carcinoma or multiple endocrine
neoplasia syndrome 2

- Severe renal impairment defined as estimated glomerular filtration rate (eGFR) less
than 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

- Known proliferative retinopathy or maculopathy requiring acute treatment according to
the opinion of the investigator

- Diagnosis of malignant neoplasm in the previous 5 years (except basal cell skin cancer
or squamous cell skin cancer)

- Mental inability, unwillingness or language barrier precluding adequate understanding
of or compliance with study procedures
We found this trial at
122
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Kettering, Ohio 45429
747
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Kettering, OH
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Albuquerque, New Mexico 87102
523
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Altoona, Pennsylvania 16602
1056
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Amarillo, Texas 79106
283
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Anaheim, California 92801
1157
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Arlington, Virginia 22206
1123
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Austin, Texas 78731
517
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Avon, Indiana 46123
630
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Beaver, Pennsylvania 15009
957
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Berlin, New Jersey 08009
1237
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Birmingham, Alabama 35215
684
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Brooklyn, New York 11215
1056
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Buckley, Michigan 49620
784
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Buenos Aires,
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Butte, Montana 59701
944
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Canal Fulton, Ohio 44614
892
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Carlisle, Ohio 45005
896
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Carmichael, California 95608
1274
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Chattanooga, Tennessee 37404
721
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Chicago, Illinois 60612
609
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Chula Vista, California 91910
1140
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Cincinnati, Ohio 45229
727
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Clairton, Pennsylvania 15025
977
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Clearwater, Florida 33756
1102
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Cleveland, Ohio 44106
894
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Colorado Springs, Colorado 80910
383
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Conyers, Georgia 30094
823
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Cooper City, Florida 33024
1304
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Corvallis, Oregon 97330
1397
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Council Bluffs, Iowa 51501
264
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Crestview Hills, Kentucky 41017
721
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Dallas, Texas 75231
341
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409
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Elk Grove, California 95758
1278
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Fargo, North Dakota 58122
633
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Flint, Michigan 48504
826
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Fort Worth, Texas 76104
348
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Gaffney, South Carolina 29341
916
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Gilbert, Arizona 85295
840
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Greensboro, North Carolina 27408
1001
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Gurnee, Illinois 60031
613
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Hialeah, Florida 33012
1313
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Houston, Texas 77030
572
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Humble, Texas 77338
555
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339
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Indianapolis, Indiana 46260
643
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1176
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Irving, Texas 75061
338
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1058
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746
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Kenosha, Wisconsin 53142
622
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Kissimmee, Florida 34744
1150
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775
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1134
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582
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1136
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402
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409
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737
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797
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Miami Lakes, Florida 33016
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Morehead City, North Carolina 28557
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Morganton, North Carolina 28655
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Murrells Inlet, South Carolina 29576
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Natchitoches, Louisiana 71457
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New Windsor, New York 12553
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816
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Paducah, Kentucky 42003
507
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Park City, Kansas 67219
27
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Peoria, Illinois 61615
485
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332
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576
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