The Efficacy of Insulin Degludec/Liraglutide in Controlling Glycaemia in Adults With Type 2 Diabetes Inadequately Controlled on GLP-1 Receptor Agonist and OAD Therapy



Status:Completed
Conditions:Diabetes
Therapuetic Areas:Endocrinology
Healthy:No
Age Range:18 - Any
Updated:1/5/2019
Start Date:August 29, 2012
End Date:March 11, 2014

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The Efficacy of Insulin Degludec/Liraglutide in Controlling Glycaemia in Adults With Type 2 Diabetes Inadequately Controlled on GLP-1 Receptor Agonist and OAD Therapy (DUAL™ III -GLP-1 Switch)

This trial is conducted in Europe, Oceania and the United States of America (USA).

The aim of the trial is to investigate the efficacy of insulin degludec/liraglutide in
controlling glycaemia in adults with type 2 diabetes inadequately controlled on glucagon-like
peptide-1 (GLP-1) receptor agonist and OAD therapy.


Inclusion Criteria:

- Subjects with type 2 diabetes mellitus

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

- Treatment with daily GLP-1 receptor agonist at maximum dose according to local label
(i.e. 1.8 mg once daily (OD) Victoza® (liraglutide) or 10 microgram twice daily (BID)
Byetta® (exenatide)) or documented maximum tolerated dose (i.e. 1.2 mg OD Victoza®
(liraglutide) or 5 microgram BID Byetta® (exenatide)) in combination with a stable
daily dose of metformin (equal to or above 1500 mg or documented maximum tolerated
dose) for 90 days or more prior to screening visit (Visit 1)

- BMI (body mass index) equal to or below 40 kg/m^2

Exclusion Criteria:

- Any use of oral anti-diabetic drugs (OADs) (except for metformin, pioglitazone and
sulphonylurea) for 90 days or less prior to screening visit (Visit 1)

- Use of any drug (except metformin,pioglitazone, sulphonylurea and GLP-1 receptor
agonist) which in the Investigator's opinion could interfere with the blood glucose
level (e.g. systemic corticosteroids)

- 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 equal to or above 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 clinically 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 products

- History of chronic pancreatitis or idiopathic acute pancreatitis
We found this trial at
77
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Altoona, Pennsylvania 16602
247
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Altoona, PA
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Arlington, Texas 76012
928
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Arlington Heights, Illinois 60004
348
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Atlanta, Georgia 30318
436
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Austin, Texas 78731
1065
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Berlin, New Jersey 08009
429
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Birmingham, Alabama 35215
481
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Birmingham, AL
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Bradenton, Florida 34201
868
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Bradenton, FL
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Chattanooga, Tennessee 37404
362
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Coffs Harbour, New South Wales
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Colorado Springs, Colorado 80910
1161
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Columbus, Ohio 43205
1
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Columbus, OH
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Concord, California 94520
2081
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Concord, CA
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Dallas, Texas 75231
905
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Dallas, TX
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65
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Dayton, OH
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Encino, California 91436
1983
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Encino, CA
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Fair Oaks, California 95628
2125
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Flemington, New Jersey 08822
432
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Fort Myers, Florida 33912
924
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Fort Worth, Texas 76104
937
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Fresno, California 93702
1988
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Goodyear, Arizona 85395
1677
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Greenbrae, California 94904
2109
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Hamilton, New Jersey 08619
472
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Henderson, Nevada 89052
1755
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Honolulu, Hawaii 96814
4501
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Houston, Texas 77030
995
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Indianapolis, Indiana 46260
166
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Indianapolis, IN
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Jacksonville, Florida 32207
672
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Jellico, Tennessee 37762
240
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Kalamazoo, Michigan 49009
211
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Kingsport, Tennessee 37660
237
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Lancaster, California 93534
1950
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Las Vegas, Nevada 89128
1762
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Lawrenceville, New Jersey 08648
438
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Lexington, Kentucky 40503
157
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Lomita, California 90717
1982
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Long Beach, California 90807
1974
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Mesa, Arizona 85206
1650
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Miami, Florida 33136
992
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Miami Springs, Florida 33166
989
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Mineola, New York 11501
496
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Montclair, California 91763
1942
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Morehead City, North Carolina 28557
500
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Myrtle Beach, South Carolina 29572
490
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Nashua, New Hampshire 03063
629
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Nashville, Tennessee 37203
333
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North Massapequa, New York 11758
505
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Northridge, California 91325
1981
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Omaha, Nebraska 68114
682
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1508
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Orlando, Florida 32804
792
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Phoenix, Arizona 85053
1662
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Pittsburgh, Pennsylvania 15224
163
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Plano, TX
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Plant City, Florida 33563
827
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1940
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Reno, NV
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Richmond, Virginia 23219
342
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Rockville, Maryland 20852
320
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Roswell, Georgia 30076
414
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Round Rock, Texas 78681
1052
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Saint Charles, Missouri 63303
406
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Saint George, Utah 84790
1655
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Salt Lake City, Utah 84132
1513
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San Antonio, Texas 78224
1138
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San Mateo, California 94401
2108
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San Ramon, California 94583
2084
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Schertz, Texas 78154
1122
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Sugar Land, Texas 77479
1009
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Sumter, South Carolina 29150
443
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Tarzana, California 91356
1985
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Toms River, New Jersey 08755
467
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Troy, Michigan 48098
303
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Tullahoma, Tennessee 37388
362
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Van Nuys, California 91405
1979
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West Seneca, New York 14224
295
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Winter Haven, Florida 33880
828
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