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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West Seneca, New York 14224
2184
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Albuquerque, New Mexico 87102
650
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Altoona, Pennsylvania 16602
2203
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Amarillo, Texas 79106
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Anaheim, California 92801
16
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Arlington, Virginia 22206
2277
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Austin, Texas 78731
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Avon, Indiana 46123
1780
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Beaver, Pennsylvania 15009
2103
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Berlin, New Jersey 08009
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Birmingham, Alabama 35215
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Brooklyn, New York 11215
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Buckley, Michigan 49620
1857
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Butte, Montana 59701
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Canal Fulton, Ohio 44614
2035
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Carlisle, Ohio 45005
2047
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Carmichael, California 95608
364
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Chattanooga, Tennessee 37404
1855
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Chicago, Illinois 60612
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Chula Vista, California 91910
112
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Clairton, Pennsylvania 15025
2125
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Clearwater, Florida 33756
2117
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2032
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Colorado Springs, Colorado 80910
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Conyers, Georgia 30094
1941
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Cooper City, Florida 33024
2309
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Corvallis, Oregon 97330
776
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Council Bluffs, Iowa 51501
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Crestview Hills, Kentucky 41017
1875
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Dallas, Texas 75231
1225
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Elk Grove, California 95758
353
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1416
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Flint, Michigan 48504
1939
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Fort Worth, Texas 76104
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Gaffney, South Carolina 29341
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Gilbert, Arizona 85295
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Greensboro, North Carolina 27408
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Gurnee, Illinois 60031
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Irving, Texas 75061
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Jacksonville, Florida 32207
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Jersey Shore, Pennsylvania 17740
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Johns Creek, Georgia 30097
1872
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Marietta, Georgia 30060
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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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Rapid City, South Dakota 57701
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Renton, Washington 98057
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Rialto, California 92376
36
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Rolling Hills Estates, California 90274
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Roseville, California 95661
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Roswell, Georgia 30076
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Saint George, Utah 84790
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Saint Louis, Missouri 63110
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Salt Lake City, Utah 84132
570
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San Antonio, Texas 78224
1188
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