The Efficacy of Insulin Degludec/Liraglutide as add-on Therapy in Controlling Glycaemia in Adults With Type 2 Diabetes Inadequately Controlled on Sulphonylurea With or Without Metformin Therapy



Status:Completed
Conditions:Diabetes
Therapuetic Areas:Endocrinology
Healthy:No
Age Range:18 - Any
Updated:10/29/2017
Start Date:August 29, 2012
End Date:October 23, 2013

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This trial is conducted in Asia, Europe and the United States of America (USA). The aim of
this trial is to investigate the efficacy and safety of insulin degludec/liraglutide in
insulin naïve subjects inadequately controlled with SU (sulphonylurea) alone or in
combination with metformin. All subjects will continue their pre-trial SU treatment with or
without metformin treatment without changing the frequency or dose throughout the trial.


Inclusion Criteria:

- Subjects with type 2 diabetes mellitus

- HbA1c 7.0-9.0% (53-75 mmol/mol) (both inclusive)

- Subjects on stable daily dose of sulphonylurea (above or equal to half of the max
approved dose according to local label) with or without metformin (above or equal to
1500 mg or max tolerated dose) for at least 90 days prior to screening visit (Visit 1)

- Body Mass Index (BMI) below or equal to 40 kg/m^2

Exclusion Criteria:

- Any use of oral anti-diabetic drugs (OADs) (other than SU in monotherapy or in
combinationwith metformin) below or equal to 90 days prior to screening visit (Visit
1)

- Use of any drug (other than SU in monotherapy or in combination with metformin), which
in the Investigators opinion could interfere with the blood glucose level (e.g.
systemic corticosteroids)

- Previous treatment with glucagon-like peptide-1 (GLP-1) receptor agonist (e.g.
exenatide, liraglutide)

- Treatment with any insulin regimen (short term treatment due to intercurrent illness
including gestational diabetes is allowed at the discretion of the Investigator)

- Screening calcitonin above or equal to 50 ng/l

- Personal or family history of medullary thyroid carcinoma (MTC) or multiple endocrine
neoplasia type 2 (MEN2)

- Cardiovascular disorders defined as: congestive heart failure (New York Heart
Association (NYHA) class III-IV), diagnosis of unstable angina pectoris, cerebral
stroke and/or myocardial infarction within the past 52 weeks prior to screening visit
(Visit 1) and/or planned coronary,carotid or peripheral artery revascularisation
procedures

- Proliferative retinopathy requiring acute treatment or maculopathy (macular oedema)
according to the Investigator's opinion

- Subjects with a clinical significant, active (during the past 12 months) disease of
the gastrointestinal, pulmonary, endocrinological (except for the Type 2 Diabetes
Mellitus),neurological, genitourinary or haematological system that in the opinion of
the Investigator,may confound the results of the trial or pose additional risk in
administering trial product

- History of chronic pancreatitis or idiopathic acute pancreatitis
We found this trial at
43
sites
Nashville, Tennessee 37203
618
mi
from
Nashville, TN
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Anaheim, California 92801
1157
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Anaheim, CA
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Atlanta, Georgia 30318
801
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Atlanta, GA
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Beaver, Pennsylvania 15009
957
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Beaver, PA
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Chattanooga, Tennessee 37404
721
mi
from
Chattanooga, TN
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Chesterfield, Missouri 63017
398
mi
from
Chesterfield, MO
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Cincinnati, Ohio 45229
727
mi
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Cincinnati, OH
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Crestview Hills, Kentucky 41017
721
mi
from
Crestview Hills, KY
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Dallas, Texas 75231
341
mi
from
Dallas, TX
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Franklin, Ohio 45005
739
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Franklin, OH
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Garden Grove, California 92844
1158
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Garden Grove, CA
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Greer, South Carolina 29651
888
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Greer, SC
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Gurnee, Illinois 60031
613
mi
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Gurnee, IL
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339
mi
from
Hurst, TX
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Kingsport, Tennessee 37660
843
mi
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Kingsport, TN
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Kissimmee, Florida 34744
1150
mi
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Kissimmee, FL
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La Jolla, California 92037
1145
mi
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La Jolla, CA
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Lodi, New Jersey 07644
1283
mi
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Lodi, NJ
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Long Beach, California 90807
1169
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Long Beach, CA
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Los Angeles, California 90027
1169
mi
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Los Angeles, CA
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?
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Lukovit,
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737
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Mason, OH
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Melbourne, Florida 32901
1198
mi
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Melbourne, FL
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Meridian, Idaho 83646
1053
mi
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Meridian, ID
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Miami, Florida 33136
1320
mi
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Miami, FL
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Nashua, New Hampshire 03063
1425
mi
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Nashua, NH
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Newport News, Virginia 23606
1173
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Oklahoma City, Oklahoma 73112
158
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Oklahoma City, OK
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Pelzer, South Carolina 29669
882
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Pelzer, SC
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Philadelphia, Pennsylvania 19104
1223
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Philadelphia, PA
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Richmond, Virginia 23219
1111
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Richmond, VA
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Rockville, Maryland 20852
1122
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Rockville, MD
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Roswell, Georgia 30076
795
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Roswell, GA
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Saint Charles, Missouri 63303
404
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Saint Charles, MO
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Salt Lake City, Utah 84132
779
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Salt Lake City, UT
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San Mateo, California 94401
1337
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San Mateo, CA
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Simpsonville, South Carolina 29681
890
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Simpsonville, SC
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Spartanburg, South Carolina 29303
903
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Spartanburg, SC
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Sugar Land, Texas 77479
575
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Sugar Land, TX
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Tabor City, North Carolina 28463
1086
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Tabor City, NC
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Troy, Michigan 48098
742
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Troy, MI
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Walnut Creek, California 94598
1318
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Walnut Creek, CA
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West Seneca, New York 14224
1059
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West Seneca, NY
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