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
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339
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Hurst, TX
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Albuquerque, New Mexico 87102
523
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Amarillo, Texas 79106
283
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Anaheim, California 92801
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Ann Arbor, Michigan 48106
806
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Athens, Tennessee 37303
750
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Avon, Indiana 46123
630
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Avon, IN
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Bountiful, Utah 84010
781
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Bradenton, Florida 34201
1142
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Bristol, Tennessee 37620
863
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Chattanooga, Tennessee 37404
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Chicago, Illinois 60612
609
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Cincinnati, Ohio 45229
727
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Cincinnati, OH
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Council Bluffs, Iowa 51501
264
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Dallas, Texas 75231
341
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744
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Dayton, OH
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Essen,
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Fleming Island, Florida 32003
1061
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Flint, Michigan 48504
826
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Fort Worth, Texas 76104
348
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Fresno, California 93702
1205
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Gillespie, Illinois 62033
443
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Gillespie, IL
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Greenfield, Indiana 46140
663
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Houston, Texas 77030
572
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Houston, TX
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Indianapolis, Indiana 46260
643
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Jackson, Mississippi 39209
572
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Jacksonville, Florida 32207
1058
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Kalamazoo, Michigan 49009
714
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562
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Katy, TX
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Kenosha, Wisconsin 53142
622
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Kettering, Ohio 45429
747
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Kingsport, Tennessee 37660
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Las Vegas, Nevada 89128
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Levittown, Pennsylvania 19056
1242
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Lexington, Kentucky 40503
724
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Lomita, California 90717
1178
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Los Angeles, California 90027
1169
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Mesquite, Texas 75149
351
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Metairie, Louisiana 70002
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Muncie, Indiana 47304
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Northridge, California 91325
1179
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Oklahoma City, Oklahoma 73112
158
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Overland Park, Kansas 66209
190
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Paducah, Kentucky 42003
507
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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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Roswell, Georgia 30076
795
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San Antonio, Texas 78224
576
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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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Van Nuys, California 91405
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Waterbury, Connecticut 06708
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West Seneca, New York 14224
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Yukon, Oklahoma 73099
155
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