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
Albuquerque, New Mexico 87102
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Amarillo, Texas 79106
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Anaheim, California 92801
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Ann Arbor, Michigan 48106
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Athens, Tennessee 37303
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Avon, Indiana 46123
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Avon, IN
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Bountiful, Utah 84010
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Bradenton, Florida 34201
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Bristol, Tennessee 37620
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Chattanooga, Tennessee 37404
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Chicago, Illinois 60612
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Chicago, IL
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Cincinnati, Ohio 45229
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Council Bluffs, Iowa 51501
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Dallas, Texas 75231
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Dayton, OH
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Essen,
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Fleming Island, Florida 32003
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Fleming Island, FL
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Flint, Michigan 48504
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Fort Worth, Texas 76104
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Fresno, California 93702
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Gillespie, Illinois 62033
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Greenfield, Indiana 46140
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Houston, Texas 77030
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Houston, TX
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Hurst, TX
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Indianapolis, Indiana 46260
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Jackson, Mississippi 39209
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Jacksonville, Florida 32207
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Kalamazoo, Michigan 49009
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Katy, TX
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Kenosha, Wisconsin 53142
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Kettering, Ohio 45429
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Kingsport, Tennessee 37660
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Las Vegas, Nevada 89128
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Levittown, Pennsylvania 19056
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Lexington, Kentucky 40503
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Lomita, California 90717
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Los Angeles, California 90027
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Mesquite, Texas 75149
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Metairie, Louisiana 70002
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Muncie, Indiana 47304
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Northridge, California 91325
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Oklahoma City, Oklahoma 73112
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Oklahoma City, OK
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Overland Park, Kansas 66209
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Paducah, Kentucky 42003
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Philadelphia, Pennsylvania 19104
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Phoenix, Arizona 85053
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Port Charlotte, Florida 33952
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Poway, California 92064
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Richmond, Virginia 23219
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Riverside, California 92506
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Rockville, Maryland 20852
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Roseville, California 95661
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Roswell, Georgia 30076
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San Antonio, Texas 78224
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San Ramon, California 94583
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Skokie, Illinois 60077
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Spring Hill, Florida 34609
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Sugar Land, Texas 77479
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Tampa, Florida 33612
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Teaneck, New Jersey 07666
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Topeka, Kansas 66606
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Van Nuys, California 91405
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Walnut Creek, California 94598
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Waltham, Massachusetts 02453
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Waterbury, Connecticut 06708
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West Seneca, New York 14224
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Yukon, Oklahoma 73099
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