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
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Dallas, Texas 75231
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Anaheim, California 92801
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Atlanta, Georgia 30318
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Beaver, Pennsylvania 15009
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Chattanooga, Tennessee 37404
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Chesterfield, Missouri 63017
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Cincinnati, Ohio 45229
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Crestview Hills, Kentucky 41017
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Franklin, Ohio 45005
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Garden Grove, California 92844
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Greer, South Carolina 29651
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Gurnee, Illinois 60031
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Hurst, TX
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Kingsport, Tennessee 37660
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Kissimmee, Florida 34744
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La Jolla, California 92037
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Lodi, New Jersey 07644
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Long Beach, California 90807
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Los Angeles, California 90027
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Lukovit,
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Mason, OH
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Melbourne, Florida 32901
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Meridian, Idaho 83646
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Miami, Florida 33136
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Nashua, New Hampshire 03063
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Nashville, Tennessee 37203
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Newport News, Virginia 23606
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Oklahoma City, Oklahoma 73112
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Pelzer, South Carolina 29669
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Philadelphia, Pennsylvania 19104
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Richmond, Virginia 23219
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Rockville, Maryland 20852
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Roswell, Georgia 30076
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Saint Charles, Missouri 63303
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Salt Lake City, Utah 84132
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San Mateo, California 94401
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Simpsonville, South Carolina 29681
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Spartanburg, South Carolina 29303
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Sugar Land, Texas 77479
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Tabor City, North Carolina 28463
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Troy, Michigan 48098
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Walnut Creek, California 94598
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West Seneca, New York 14224
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