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

Use our guide to learn which trials are right for you!

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
Muncie, Indiana 47304
125
mi
from 43215
Muncie, IN
Click here to add this to my saved trials
Albuquerque, New Mexico 87102
1333
mi
from 43215
Albuquerque, NM
Click here to add this to my saved trials
Amarillo, Texas 79106
1078
mi
from 43215
Amarillo, TX
Click here to add this to my saved trials
Anaheim, California 92801
1962
mi
from 43215
Anaheim, CA
Click here to add this to my saved trials
Ann Arbor, Michigan 48106
164
mi
from 43215
Ann Arbor, MI
Click here to add this to my saved trials
Athens, Tennessee 37303
324
mi
from 43215
Athens, TN
Click here to add this to my saved trials
Avon, Indiana 46123
179
mi
from 43215
Avon, IN
Click here to add this to my saved trials
Bountiful, Utah 84010
1512
mi
from 43215
Bountiful, UT
Click here to add this to my saved trials
Bradenton, Florida 34201
868
mi
from 43215
Bradenton, FL
Click here to add this to my saved trials
Bristol, Tennessee 37620
237
mi
from 43215
Bristol, TN
Click here to add this to my saved trials
Chattanooga, Tennessee 37404
362
mi
from 43215
Chattanooga, TN
Click here to add this to my saved trials
Chicago, Illinois 60612
274
mi
from 43215
Chicago, IL
Click here to add this to my saved trials
Cincinnati, Ohio 45229
95
mi
from 43215
Cincinnati, OH
Click here to add this to my saved trials
Council Bluffs, Iowa 51501
678
mi
from 43215
Council Bluffs, IA
Click here to add this to my saved trials
Dallas, Texas 75231
905
mi
from 43215
Dallas, TX
Click here to add this to my saved trials
65
mi
from 43215
Dayton, OH
Click here to add this to my saved trials
?
mi
from 43215
Essen,
Click here to add this to my saved trials
Fleming Island, Florida 32003
686
mi
from 43215
Fleming Island, FL
Click here to add this to my saved trials
Flint, Michigan 48504
213
mi
from 43215
Flint, MI
Click here to add this to my saved trials
Fort Worth, Texas 76104
937
mi
from 43215
Fort Worth, TX
Click here to add this to my saved trials
Fresno, California 93702
1988
mi
from 43215
Fresno, CA
Click here to add this to my saved trials
Gillespie, Illinois 62033
366
mi
from 43215
Gillespie, IL
Click here to add this to my saved trials
Greenfield, Indiana 46140
146
mi
from 43215
Greenfield, IN
Click here to add this to my saved trials
Houston, Texas 77030
995
mi
from 43215
Houston, TX
Click here to add this to my saved trials
925
mi
from 43215
Hurst, TX
Click here to add this to my saved trials
Indianapolis, Indiana 46260
166
mi
from 43215
Indianapolis, IN
Click here to add this to my saved trials
Jackson, Mississippi 39209
662
mi
from 43215
Jackson, MS
Click here to add this to my saved trials
Jacksonville, Florida 32207
672
mi
from 43215
Jacksonville, FL
Click here to add this to my saved trials
Kalamazoo, Michigan 49009
211
mi
from 43215
Kalamazoo, MI
Click here to add this to my saved trials
1008
mi
from 43215
Katy, TX
Click here to add this to my saved trials
Kenosha, Wisconsin 53142
308
mi
from 43215
Kenosha, WI
Click here to add this to my saved trials
Kettering, Ohio 45429
63
mi
from 43215
Kettering, OH
Click here to add this to my saved trials
Kingsport, Tennessee 37660
237
mi
from 43215
Kingsport, TN
Click here to add this to my saved trials
Las Vegas, Nevada 89128
1762
mi
from 43215
Las Vegas, NV
Click here to add this to my saved trials
Levittown, Pennsylvania 19056
433
mi
from 43215
Levittown, PA
Click here to add this to my saved trials
Lexington, Kentucky 40503
157
mi
from 43215
Lexington, KY
Click here to add this to my saved trials
Lomita, California 90717
1982
mi
from 43215
Lomita, CA
Click here to add this to my saved trials
Los Angeles, California 90027
1973
mi
from 43215
Los Angeles, CA
Click here to add this to my saved trials
Mesquite, Texas 75149
903
mi
from 43215
Mesquite, TX
Click here to add this to my saved trials
Metairie, Louisiana 70002
796
mi
from 43215
Metairie, LA
Click here to add this to my saved trials
Northridge, California 91325
1981
mi
from 43215
Northridge, CA
Click here to add this to my saved trials
Oklahoma City, Oklahoma 73112
849
mi
from 43215
Oklahoma City, OK
Click here to add this to my saved trials
Overland Park, Kansas 66209
624
mi
from 43215
Overland Park, KS
Click here to add this to my saved trials
Paducah, Kentucky 42003
361
mi
from 43215
Paducah, KY
Click here to add this to my saved trials
Philadelphia, Pennsylvania 19104
414
mi
from 43215
Philadelphia, PA
Click here to add this to my saved trials
Phoenix, Arizona 85053
1662
mi
from 43215
Phoenix, AZ
Click here to add this to my saved trials
Port Charlotte, Florida 33952
899
mi
from 43215
Port Charlotte, FL
Click here to add this to my saved trials
Poway, California 92064
1938
mi
from 43215
Poway, CA
Click here to add this to my saved trials
Richmond, Virginia 23219
342
mi
from 43215
Richmond, VA
Click here to add this to my saved trials
Riverside, California 92506
1929
mi
from 43215
Riverside, CA
Click here to add this to my saved trials
Rockville, Maryland 20852
320
mi
from 43215
Rockville, MD
Click here to add this to my saved trials
Roseville, California 95661
2028
mi
from 43215
Roseville, CA
Click here to add this to my saved trials
Roswell, Georgia 30076
414
mi
from 43215
Roswell, GA
Click here to add this to my saved trials
San Antonio, Texas 78224
1138
mi
from 43215
San Antonio, TX
Click here to add this to my saved trials
San Ramon, California 94583
2084
mi
from 43215
San Ramon, CA
Click here to add this to my saved trials
Skokie, Illinois 60077
285
mi
from 43215
Skokie, IL
Click here to add this to my saved trials
Spring Hill, Florida 34609
700
mi
from 43215
Spring Hill, FL
Click here to add this to my saved trials
Sugar Land, Texas 77479
1009
mi
from 43215
Sugar Land, TX
Click here to add this to my saved trials
Tampa, Florida 33612
823
mi
from 43215
Tampa, FL
Click here to add this to my saved trials
Teaneck, New Jersey 07666
478
mi
from 43215
Teaneck, NJ
Click here to add this to my saved trials
Topeka, Kansas 66606
676
mi
from 43215
Topeka, KS
Click here to add this to my saved trials
Van Nuys, California 91405
1979
mi
from 43215
Van Nuys, CA
Click here to add this to my saved trials
Walnut Creek, California 94598
2084
mi
from 43215
Walnut Creek, CA
Click here to add this to my saved trials
Waltham, Massachusetts 02453
633
mi
from 43215
Waltham, MA
Click here to add this to my saved trials
Waterbury, Connecticut 06708
531
mi
from 43215
Waterbury, CT
Click here to add this to my saved trials
West Seneca, New York 14224
295
mi
from 43215
West Seneca, NY
Click here to add this to my saved trials
Yukon, Oklahoma 73099
860
mi
from 43215
Yukon, OK
Click here to add this to my saved trials