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

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

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
130
sites
Atlanta, Georgia 30318
1919
mi
from 91732
Atlanta, GA
Click here to add this to my saved trials
Albany, New York 12208
2438
mi
from 91732
Albany, NY
Click here to add this to my saved trials
Anaheim, California 92801
16
mi
from 91732
Anaheim, CA
Click here to add this to my saved trials
Asheboro, North Carolina 27203
2154
mi
from 91732
Asheboro, NC
Click here to add this to my saved trials
Asheville, North Carolina 28801
2002
mi
from 91732
Asheville, NC
Click here to add this to my saved trials
Avon, Illinois 46123
1573
mi
from 91732
Avon, IL
Click here to add this to my saved trials
Beaver, Pennsylvania 15009
2103
mi
from 91732
Beaver, PA
Click here to add this to my saved trials
Bermuda Dunes, California 92203
101
mi
from 91732
Bermuda Dunes, CA
Click here to add this to my saved trials
Birmingham, Alabama 35215
1788
mi
from 91732
Birmingham, AL
Click here to add this to my saved trials
Bridgeville, Pennsylvania 15017
2113
mi
from 91732
Bridgeville, PA
Click here to add this to my saved trials
Broadmeadow, New South Wales
?
mi
from 91732
Broadmeadow,
Click here to add this to my saved trials
Bronx, New York 10467
2436
mi
from 91732
Bronx, NY
Click here to add this to my saved trials
Buckley, Michigan 49620
1857
mi
from 91732
Buckley, MI
Click here to add this to my saved trials
920 Massachusetts Avenue Northwest
Burke, Virginia 22015
2281
mi
from 91732
Burke, VA
Click here to add this to my saved trials
Burlington, North Carolina 27215
2171
mi
from 91732
Burlington, NC
Click here to add this to my saved trials
2047
mi
from 91732
Canton, OH
Click here to add this to my saved trials
Chapel Hill, North Carolina 27599
2194
mi
from 91732
Chapel Hill, NC
Click here to add this to my saved trials
Charlotte, North Carolina 28277
2101
mi
from 91732
Charlotte, NC
Click here to add this to my saved trials
Chattanooga, Tennessee 37404
1855
mi
from 91732
Chattanooga, TN
Click here to add this to my saved trials
Chesterfield, Missouri 63017
1552
mi
from 91732
Chesterfield, MO
Click here to add this to my saved trials
Chicago, Illinois 60612
1728
mi
from 91732
Chicago, IL
Click here to add this to my saved trials
Cincinnati, Ohio 45229
1881
mi
from 91732
Cincinnati, OH
Click here to add this to my saved trials
Clearwater, Florida 33756
2117
mi
from 91732
Clearwater, FL
Click here to add this to my saved trials
Cleveland, Ohio 44106
2032
mi
from 91732
Cleveland, OH
Click here to add this to my saved trials
Colorado Springs, Colorado 80910
804
mi
from 91732
Colorado Springs, CO
Click here to add this to my saved trials
Columbia, South Carolina 29203
2105
mi
from 91732
Columbia, SC
Click here to add this to my saved trials
Columbus, Georgia 31904
1902
mi
from 91732
Columbus, GA
Click here to add this to my saved trials
Columbus, Ohio 43205
1960
mi
from 91732
Columbus, OH
Click here to add this to my saved trials
Concord, California 94520
353
mi
from 91732
Concord, CA
Click here to add this to my saved trials
Conyers, Georgia 30094
1941
mi
from 91732
Conyers, GA
Click here to add this to my saved trials
Crestview Hills, Kentucky 41017
1875
mi
from 91732
Crestview Hills, KY
Click here to add this to my saved trials
Dallas, Texas 75231
1225
mi
from 91732
Dallas, TX
Click here to add this to my saved trials
Decatur, Georgia 30033
1924
mi
from 91732
Decatur, GA
Click here to add this to my saved trials
Delray Beach, Florida 33484
2310
mi
from 91732
Delray Beach, FL
Click here to add this to my saved trials
Denver, Colorado 80220
818
mi
from 91732
Denver, CO
Click here to add this to my saved trials
DeSoto, Texas 75115
1223
mi
from 91732
DeSoto, TX
Click here to add this to my saved trials
East Providence, Rhode Island 02914
2564
mi
from 91732
East Providence, RI
Click here to add this to my saved trials
Encino, California 91436
28
mi
from 91732
Encino, CA
Click here to add this to my saved trials
Fair Oaks, California 95628
470
mi
from 91732
Fair Oaks, CA
Click here to add this to my saved trials
Fishers, Indiana 46038
1800
mi
from 91732
Fishers, IN
Click here to add this to my saved trials
Flemington, New Jersey 08822
2389
mi
from 91732
Flemington, NJ
Click here to add this to my saved trials
Fort Lauderdale, Florida 33316
2317
mi
from 91732
Fort Lauderdale, FL
Click here to add this to my saved trials
Fort Worth, Texas 76104
1195
mi
from 91732
Fort Worth, TX
Click here to add this to my saved trials
Franklin, Indiana 46131
1844
mi
from 91732
Franklin, IN
Click here to add this to my saved trials
Franklin, Ohio 45005
1891
mi
from 91732
Franklin, OH
Click here to add this to my saved trials
Fresno, California 93702
209
mi
from 91732
Fresno, CA
Click here to add this to my saved trials
Golden, Colorado 80401
807
mi
from 91732
Golden, CO
Click here to add this to my saved trials
Greenbrae, California 94904
367
mi
from 91732
Greenbrae, CA
Click here to add this to my saved trials
Greensboro, North Carolina 27408
2151
mi
from 91732
Greensboro, NC
Click here to add this to my saved trials
Greenville, North Carolina 27834
2290
mi
from 91732
Greenville, NC
Click here to add this to my saved trials
Greer, South Carolina 29651
2027
mi
from 91732
Greer, SC
Click here to add this to my saved trials
Gurnee, Illinois 60031
1721
mi
from 91732
Gurnee, IL
Click here to add this to my saved trials
Henderson, Nevada 89052
213
mi
from 91732
Henderson, NV
Click here to add this to my saved trials
Hialeah, Florida 33012
2314
mi
from 91732
Hialeah, FL
Click here to add this to my saved trials
Houston, Texas 77030
1357
mi
from 91732
Houston, TX
Click here to add this to my saved trials
Hyattsville, Maryland 20782
2285
mi
from 91732
Hyattsville, MD
Click here to add this to my saved trials
Indianapolis, Indiana 46260
1792
mi
from 91732
Indianapolis, IN
Click here to add this to my saved trials
Irving, Texas 75061
1213
mi
from 91732
Irving, TX
Click here to add this to my saved trials
Jacksonville, Florida 32207
2131
mi
from 91732
Jacksonville, FL
Click here to add this to my saved trials
Kansas City, Missouri 64106
1341
mi
from 91732
Kansas City, MO
Click here to add this to my saved trials
Kettering, Ohio 45429
1898
mi
from 91732
Kettering, OH
Click here to add this to my saved trials
Killeen, Texas 76543
1196
mi
from 91732
Killeen, TX
Click here to add this to my saved trials
Kingsport, Tennessee 37660
1994
mi
from 91732
Kingsport, TN
Click here to add this to my saved trials
Kissimmee, Florida 34744
2188
mi
from 91732
Kissimmee, FL
Click here to add this to my saved trials
La Jolla, California 92037
95
mi
from 91732
La Jolla, CA
Click here to add this to my saved trials
Las Vegas, Nevada 89128
213
mi
from 91732
Las Vegas, NV
Click here to add this to my saved trials
Lawrenceville, Georgia 30046
1939
mi
from 91732
Lawrenceville, GA
Click here to add this to my saved trials
Lexington, Kentucky 40503
1879
mi
from 91732
Lexington, KY
Click here to add this to my saved trials
Long Beach, California 90807
19
mi
from 91732
Long Beach, CA
Click here to add this to my saved trials
Los Angeles, California 90027
16
mi
from 91732
Los Angeles, CA
Click here to add this to my saved trials
Lubbock, Texas 79423
927
mi
from 91732
Lubbock, TX
Click here to add this to my saved trials
Manassas, Virginia 20110
2258
mi
from 91732
Manassas, VA
Click here to add this to my saved trials
1890
mi
from 91732
Mason, OH
Click here to add this to my saved trials
1931
mi
from 91732
Maumee, OH
Click here to add this to my saved trials
Melbourne, Florida 32901
2239
mi
from 91732
Melbourne, FL
Click here to add this to my saved trials
Meridian, Idaho 83646
666
mi
from 91732
Meridian, ID
Click here to add this to my saved trials
Metairie, Louisiana 70002
1649
mi
from 91732
Metairie, LA
Click here to add this to my saved trials
Miami, Florida 33136
2321
mi
from 91732
Miami, FL
Click here to add this to my saved trials
Michigan City, Indiana 46360
1765
mi
from 91732
Michigan City, IN
Click here to add this to my saved trials
Milwaukee, Wisconsin 53209
1729
mi
from 91732
Milwaukee, WI
Click here to add this to my saved trials
Montclair, California 91763
18
mi
from 91732
Montclair, CA
Click here to add this to my saved trials
Monterey, California 93940
279
mi
from 91732
Monterey, CA
Click here to add this to my saved trials
Morehead City, North Carolina 28557
2337
mi
from 91732
Morehead City, NC
Click here to add this to my saved trials
Muncie, Indiana 47304
1835
mi
from 91732
Muncie, IN
Click here to add this to my saved trials
658
mi
from 91732
Nampa, ID
Click here to add this to my saved trials
Nashua, New Hampshire 03063
2556
mi
from 91732
Nashua, NH
Click here to add this to my saved trials
Newark, Delaware 19713
2345
mi
from 91732
Newark, DE
Click here to add this to my saved trials
Newport News, Virginia 23606
2328
mi
from 91732
Newport News, VA
Click here to add this to my saved trials
Norristown, Pennsylvania 19401
2365
mi
from 91732
Norristown, PA
Click here to add this to my saved trials
North East, Maryland 21901
2336
mi
from 91732
North East, MD
Click here to add this to my saved trials
Northport, New York 11768
2466
mi
from 91732
Northport, NY
Click here to add this to my saved trials
O'Fallon, Illinois 62246
1588
mi
from 91732
O'Fallon, IL
Click here to add this to my saved trials
590
mi
from 91732
Ogden, UT
Click here to add this to my saved trials
Oklahoma City, Oklahoma 73112
1165
mi
from 91732
Oklahoma City, OK
Click here to add this to my saved trials
Orange, California 92868
21
mi
from 91732
Orange, CA
Click here to add this to my saved trials
Orlando, Florida 32804
2182
mi
from 91732
Orlando, FL
Click here to add this to my saved trials
Pelzer, South Carolina 29669
2017
mi
from 91732
Pelzer, SC
Click here to add this to my saved trials
Pembroke Pines, Florida 33026
2314
mi
from 91732
Pembroke Pines, FL
Click here to add this to my saved trials
Philadelphia, Pennsylvania 19104
2373
mi
from 91732
Philadelphia, PA
Click here to add this to my saved trials
Pittsburgh, Pennsylvania 15224
2119
mi
from 91732
Pittsburgh, PA
Click here to add this to my saved trials
Poway, California 92064
95
mi
from 91732
Poway, CA
Click here to add this to my saved trials