Dual Action of Liraglutide and Insulin Degludec in Type 2 Diabetes: A Trial Comparing the Efficacy and Safety of Insulin Degludec/Liraglutide, Insulin Degludec and Liraglutide in Subjects With Type 2 Diabetes



Status:Completed
Conditions:Diabetes, Diabetes
Therapuetic Areas:Endocrinology
Healthy:No
Age Range:18 - Any
Updated:2/21/2018
Start Date:May 23, 2011
End Date:November 22, 2012

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A 26 Week Randomised, Parallel Three-arm, Open-label, Multi-centre, Multinational Treat-to-target Trial Comparing Fixed Ratio Combination of Insulin Degludec and Liraglutide Versus Insulin Degludec or Liraglutide Alone, in Subjects With Type 2 Diabetes Treated With 1-2 Oral Anti-diabetic Drugs (OADs)With a 26 Week Extension

This trial is conducted globally. The aim of this trial is to compare the efficacy and safety
of insulin degludec/liraglutide (IDegLira) versus insulin degludec (IDeg) and liraglutide
(Lira) in subjects with type 2 diabetes. Subjects are to continue their pre-trial treatment
with metformin or metformin + pioglitazone throughout the entire trial.


Inclusion Criteria:

- Subjects with type 2 diabetes

- HbA1c 7.0-10.0 % (both inclusive) with the aim of a median HbA1c of 8.3%. Accordingly,
when approximately 50% of the randomised subjects have a HbA1c above 8.3%, the
remaining subjects randomised must have a HbA1c of below or equal to 8.3%, or when
approximately 50% of the randomised subjects have a HbA1c of below or equal to 8.3%,
the remaining subjects randomised must have a HbA1c above 8.3%

- Male or female, age 18 years or above (Taiwan: 20 years or above for a site 653 in
Taiwan: Taichung Veterans General Hospital)

- Subjects on stable dose of 1-2 OADs (metformin [at least 1500 mg or max tolerated
dose] or metformin [at least 1500 mg or max tolerated dose] + pioglitazone [at least
30 mg]) for at least 90 days prior to screening

- Body Mass Index (BMI) maximum 40 kg/m^2

Exclusion Criteria:

- Treatment with insulin (except for short-term treatment due to intercurrent illness at
the discretion of the Investigator)

- Treatment with GLP-1 (glucagon-like peptide-1) receptor agonists (eg exenatide,
liraglutide), sulphonylurea or dipeptidyl peptidase 4 (DPP-4) inhibitors within 90
days prior to trial

- Impaired liver function, defined as alanine aminotransferese (ALAT) at least 2.5 times
Upper Normal Range (UNR) (one retest analysed at the central laboratory within a week
from first sample taken is permitted with the result of the last sample being the
conclusive)

- Impaired renal function defined as serum-creatinine at least 133 mcmol/l (at least 1.5
mg/dl) for males and at least 125 mcmol/l (at least 1.4) for females, or as allowed
according to local contraindications for metformin (one retest analysed at the central
laboratory within a week from first sample taken is permitted with the result of the
last sample being the conclusive)

- Screening calcitonin at least 50 ng/L

- Subjects with personal or family history of medullary thyroid carcinoma (MTC) or
multiple endocrine neoplasia type 2 (MEN 2)

- Cardiac disorder defined as: congestive heart failure (NYHA class III-IV), diagnosis
of unstable angina pectoris, cerebral stroke and/or myocardial infarction within the
last 12 months and planned coronary, carotid or peripheral artery revascularisation
procedures

- Severe uncontrolled treated or untreated hypertension (systolic blood pressure at
least 180 mm Hg or diastolic blood pressure at least 100 mm Hg)

- Acute treatment required proliferative retinopathy or maculopathy (macular oedema)

- History of chronic pancreatitis or idiopathic acute pancreatitis
We found this trial at
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Burlington, North Carolina 27215
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Albany, New York 12208
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Anaheim, California 92801
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Asheboro, North Carolina 27203
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Asheville, North Carolina 28801
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Atlanta, Georgia 30318
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Avon, Illinois 46123
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Beaver, Pennsylvania 15009
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Bermuda Dunes, California 92203
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Broadmeadow, New South Wales
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Bronx, New York 10467
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Buckley, Michigan 49620
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920 Massachusetts Avenue Northwest
Burke, Virginia 22015
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2057
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Chapel Hill, North Carolina 27599
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Charlotte, North Carolina 28277
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Chattanooga, Tennessee 37404
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Chesterfield, Missouri 63017
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Chicago, Illinois 60612
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Cincinnati, Ohio 45229
1966
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Clearwater, Florida 33756
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Cleveland, Ohio 44106
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Colorado Springs, Colorado 80910
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Columbia, South Carolina 29203
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Columbus, Georgia 31904
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Columbus, Ohio 43205
2008
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Concord, California 94520
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Conyers, Georgia 30094
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Crestview Hills, Kentucky 41017
1966
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Dallas, Texas 75231
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Decatur, Georgia 30033
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Delray Beach, Florida 33484
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DeSoto, Texas 75115
1687
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East Providence, Rhode Island 02914
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Fishers, Indiana 46038
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Fort Lauderdale, Florida 33316
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Franklin, Ohio 45005
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Greenbrae, California 94904
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Greensboro, North Carolina 27408
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Greenville, North Carolina 27834
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Gurnee, Illinois 60031
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Henderson, Nevada 89052
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Kettering, Ohio 45429
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Melbourne, Florida 32901
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Metairie, Louisiana 70002
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Pelzer, South Carolina 29669
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Pembroke Pines, Florida 33026
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Philadelphia, Pennsylvania 19104
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