Efficacy and Safety of Semaglutide Once-weekly Versus Placebo as add-on to Basal Insulin Alone or Basal Insulin in Combination With Metformin in Subjects With Type 2 Diabetes



Status:Completed
Conditions:Diabetes, Diabetes
Therapuetic Areas:Endocrinology
Healthy:No
Age Range:18 - Any
Updated:1/31/2019
Start Date:December 1, 2014
End Date:November 21, 2015

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This trial is conducted in Asia, Europe and the United States of America (USA). The aim of
the trial is to investigate efficacy and safety of semaglutide once weekly versus placebo as
add-on to basal insulin alone or basal insulin in combination with metformin in subjects with
type 2 diabetes.


Inclusion Criteria: - Male or female, age at least 18 years at the time of signing inform
consent. For Japan: Male or female, age at least 20 years at the time of signing informed
consent - Subjects diagnosed with T2DM (type 2 diabetes mellitus) and on stable diabetes
treatment (plus/minus 20 percent change in total daily dose) with basal insulin (minimum of
0.25 IU/kg/day and/or 20 IU/day of: insulin glargine, insulin detemir, insulin degludec
and/or NPH insulin) alone or in combination with metformin (minimum of 1500 mg/day or
maximal tolerable dose) for 90 days prior to screening - HbA1c (glycosylated haemoglobin)
7.0 - 10.0 percent (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 an adequate contraceptive method throughout the trial including the 5 weeks
follow-up period (adequate contraceptive measures as required by local regulation or
practice). Germany: Only highly effective methods of birth control are accepted (ie one
that results in less than 1% per year failure rate when used consistently and correctly
such as implants, injectables, combined oral contraceptives, some intrauterine device), or
sexual abstinence or vasectomised partner. Japan: Adequate contraceptive measures are
abstinence (not having sex), diaphragm, condom (by the partner), intrauterine device,
sponge, spermicide or oral contraceptives - Treatment with any glucose lowering agents
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 bolus insulin in
connection with intercurrent illness - Experienced more than 3 episodes of severe
hypoglycaemia within 6 months prior to screening, and/or hypoglycaemia unawareness -
History of pancreatitis (acute or chronic) - Screening calcitonin value above or equal to
50 ng/L (pg/mL) - Personal or family history of medullary thyroid carcinoma (MTC) or
multiple endocrine neoplasia syndrome 2 (MEN 2) - Severe renal impairment 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 (NYHA)
Class IV
We found this trial at
67
sites
San Antonio, Texas 78224
1787
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from 98109
San Antonio, TX
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Albuquerque, New Mexico 87102
1184
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Albuquerque, NM
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Amarillo, Texas 79106
1358
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Amarillo, TX
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Anaheim, California 92801
979
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Anaheim, CA
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Ann Arbor, Michigan 48106
1902
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Ann Arbor, MI
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Athens, Tennessee 37303
2100
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Athens, TN
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Avon, Indiana 46123
1857
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Avon, IN
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Bountiful, Utah 84010
695
mi
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Bountiful, UT
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Bradenton, Florida 34201
2552
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Bradenton, FL
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Bristol, Tennessee 37620
2166
mi
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Bristol, TN
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Chattanooga, Tennessee 37404
2085
mi
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Chattanooga, TN
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Chicago, Illinois 60612
1733
mi
from 98109
Chicago, IL
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Cincinnati, Ohio 45229
1966
mi
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Cincinnati, OH
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Council Bluffs, Iowa 51501
1370
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Council Bluffs, IA
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Dallas, Texas 75231
1677
mi
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Dallas, TX
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1956
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Dayton, OH
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?
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Essen,
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Fleming Island, Florida 32003
2460
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Fleming Island, FL
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Flint, Michigan 48504
1884
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Flint, MI
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Fort Worth, Texas 76104
1662
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Fort Worth, TX
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Fresno, California 93702
763
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Fresno, CA
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Gillespie, Illinois 62033
1720
mi
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Gillespie, IL
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Greenfield, Indiana 46140
1885
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Greenfield, IN
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Houston, Texas 77030
1892
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Houston, TX
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1661
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Hurst, TX
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Indianapolis, Indiana 46260
1868
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Indianapolis, IN
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Jackson, Mississippi 39209
1983
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Jackson, MS
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Jacksonville, Florida 32207
2454
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Jacksonville, FL
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Kalamazoo, Michigan 49009
1812
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Kalamazoo, MI
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1871
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Katy, TX
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Kenosha, Wisconsin 53142
1702
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Kenosha, WI
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Kettering, Ohio 45429
1963
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Kettering, OH
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Kingsport, Tennessee 37660
2150
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Kingsport, TN
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Las Vegas, Nevada 89128
868
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Las Vegas, NV
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Levittown, Pennsylvania 19056
2382
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Levittown, PA
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Lexington, Kentucky 40503
2004
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Lexington, KY
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Lomita, California 90717
978
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Lomita, CA
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Los Angeles, California 90027
956
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Los Angeles, CA
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Mesquite, Texas 75149
1689
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Mesquite, TX
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Metairie, Louisiana 70002
2092
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Metairie, LA
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Muncie, Indiana 47304
1890
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Muncie, IN
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Northridge, California 91325
946
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Northridge, CA
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Oklahoma City, Oklahoma 73112
1523
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Oklahoma City, OK
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Overland Park, Kansas 66209
1503
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Overland Park, KS
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Paducah, Kentucky 42003
1852
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Paducah, KY
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Philadelphia, Pennsylvania 19104
2371
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Philadelphia, PA
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Phoenix, Arizona 85053
1116
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Port Charlotte, Florida 33952
2589
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Port Charlotte, FL
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Poway, California 92064
1050
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Poway, CA
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Richmond, Virginia 23219
2350
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Richmond, VA
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Riverside, California 92506
979
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Riverside, CA
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Rockville, Maryland 20852
2312
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Rockville, MD
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Roseville, California 95661
616
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Roseville, CA
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Roswell, Georgia 30076
2168
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Roswell, GA
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San Ramon, California 94583
681
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Skokie, Illinois 60077
1722
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Skokie, IL
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Spring Hill, Florida 34609
2435
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Sugar Land, Texas 77479
1887
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Sugar Land, TX
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Tampa, Florida 33612
2522
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Tampa, FL
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Teaneck, New Jersey 07666
2395
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Topeka, Kansas 66606
1455
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Van Nuys, California 91405
950
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Walnut Creek, California 94598
664
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Waltham, Massachusetts 02453
2476
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Waterbury, Connecticut 06708
2418
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West Seneca, New York 14224
2115
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Yukon, Oklahoma 73099
1511
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Yukon, OK
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