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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Anaheim, California 92801
1962
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Albuquerque, New Mexico 87102
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Altoona, Pennsylvania 16602
247
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Amarillo, Texas 79106
1078
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Arlington, Virginia 22206
324
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Austin, Texas 78731
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Avon, Indiana 46123
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Beaver, Pennsylvania 15009
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Berlin, New Jersey 08009
429
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Birmingham, Alabama 35215
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Brooklyn, New York 11215
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Buckley, Michigan 49620
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Butte, Montana 59701
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Canal Fulton, Ohio 44614
98
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Carlisle, Ohio 45005
89
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Carmichael, California 95608
2034
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Chattanooga, Tennessee 37404
362
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Chicago, Illinois 60612
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Chula Vista, California 91910
1949
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95
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Clairton, Pennsylvania 15025
167
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Clearwater, Florida 33756
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Colorado Springs, Colorado 80910
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Conyers, Georgia 30094
438
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Cooper City, Florida 33024
973
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Corvallis, Oregon 97330
2060
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Council Bluffs, Iowa 51501
678
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Crestview Hills, Kentucky 41017
105
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Elk Grove, California 95758
2040
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Fargo, North Dakota 58122
837
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Flint, Michigan 48504
213
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Fort Worth, Texas 76104
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Gaffney, South Carolina 29341
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Gilbert, Arizona 85295
1650
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Greensboro, North Carolina 27408
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Gurnee, Illinois 60031
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Hialeah, Florida 33012
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Inglewood, California 90301
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Jersey Shore, Pennsylvania 17740
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Johns Creek, Georgia 30097
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Kenosha, Wisconsin 53142
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Kettering, Ohio 45429
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Kissimmee, Florida 34744
811
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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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Ozark, Alabama 36360
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2001
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Rolling Hills Estates, California 90274
1985
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1655
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Saint Louis, Missouri 63110
394
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1951
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