A Trial Comparing the Efficacy and Safety of Insulin Degludec and Insulin Glargine 300 Units/mL in Subjects With Type 2 Diabetes Mellitus Inadequately Treated With Basal Insulin With or Without Oral Antidiabetic Drugs



Status:Completed
Conditions:Diabetes, Diabetes
Therapuetic Areas:Endocrinology
Healthy:No
Age Range:18 - Any
Updated:3/16/2019
Start Date:March 13, 2017
End Date:March 4, 2019

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This trial is conducted in Europe and North America. The aim of the trial is to compare the
efficacy and safety of insulin degludec and insulin glargine 300 units/mL in subjects with
type 2 diabetes mellitus inadequately treated with basal insulin with or without oral
antidiabetic drugs. Due to change in glycaemic data collection process, this trial is amended
to allow for a full 36 weeks (maintenance 2 period) of the use of the new process.


Inclusion criteria: - Male or female, age above or equal to 18 years at the time of signing
informed consent. - Subjects fulfilling at least one of the below criteria (For this
inclusion criterion the aim is to include minimum 80% of individuals with a previous
episode of hypoglycaemia (criterion e). The remaining subjects will have to fulfil at least
one of criteria a-d.): - a) Experienced at least one severe hypoglycaemic episode within
the last year (according to the ADA definition, April 2013 (An episode requiring assistance
of another person to actively administer carbohydrate, glucagon, or take other corrective
actions. Plasma glucose concentrations may not be available during an event, but
neurological recovery following the return of plasma glucose to normal is considered
sufficient evidence that the event was induced by a low plasma glucose concentration.). -
b) Moderate chronic renal failure, defined as glomerular filtration rate 30 - 59
mL/min/1.73 m^2 per CKD-EPI by central laboratory analysis. - c) Hypoglycaemic symptom
unawareness (History of impaired autonomic responses (tremulousness, sweating,
palpitations, and hunger) during hypoglycaemia). - d) Treated with insulin for more than 5
years. - e) Episode of hypoglycaemia (defined by symptoms of hypoglycaemia and/or episode
with low glucose measurement (equal to or below 70 mg/dL [equal to or below 3.9 mmol/L]))
within the last 12 weeks prior to Visit 1 (screening). - Subjects diagnosed (clinically)
with type 2 diabetes mellitus. - Treated with basal only insulin (once daily or twice-daily
insulin (insulin detemir; insulin glargine 100 U/mL, biosimilar of insulin glargine 100
U/mL or insulin Neutral Protamine Hagedorn)) equal to or above 90 days prior to the day of
screening with or without any of the following anti-diabetic drugs with stable doses for
equal to or above 90 days prior to screening: - a) Metformin - b) Dipeptidyl peptidase -4
inhibitor - c) Sodium-glucose co-transporter 2 inhibitor - d) Alpha-glucosidase-inhibitors
(acarbose) - e) Thiazolidinediones - f) Marketed oral combination products only including
the products listed in criteria 5a-5e - HbA1c equal to or below 9.5% (80 mmol/mol) at
screening by central laboratory analysis. - BMI equal to or below 45 kg/m^2. Exclusion
Criteria: - Treatment with any medication for the indication of diabetes or obesity other
than stated in the inclusion criteria in a period of 90 days before the day of screening
We found this trial at
139
sites
Marietta, Georgia 30060
2163
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Marietta, GA
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Albany, New York 12208
2351
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Albuquerque, New Mexico 87102
1184
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Amarillo, Texas 79106
1358
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Anderson, South Carolina 29621
2227
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Anniston, Alabama 36207
2117
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Anniston, AL
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Arlington, Texas 76012
1667
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Austin, Texas 78731
1770
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Austin, TX
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Beaver, Pennsylvania 15009
2110
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Beaver, PA
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Bennington, Vermont 05201
2372
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Birmingham, Alabama 35215
2077
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Blackfoot, Idaho 83221
573
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Blackfoot, ID
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Bloomfield Hills, Michigan 48302
1916
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Bloomfield Hills, MI
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Bountiful, Utah 84010
695
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Bradenton, Florida 34201
2552
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Brandon, Florida 33511
2535
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Bristol, Tennessee 37620
2166
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Bristol, TN
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?
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Calgary,
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Chandler, Arizona 85224
1128
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Charlotte, North Carolina 28277
2281
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Chattanooga, Tennessee 37404
2085
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Chesapeake, Virginia 23321
2426
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Chesterfield, Missouri 63017
1702
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Chicago, Illinois 60612
1733
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Clearwater, Florida 33756
2512
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Colorado Springs, Colorado 80910
1070
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Columbus, Ohio 43205
2008
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Concord, California 94520
663
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Concord, CA
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Cooper City, Florida 33024
2714
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Council Bluffs, Iowa 51501
1370
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Dakota Dunes, South Dakota 57049
1304
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Dallas, Texas 75231
1677
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Downey, California 90242
972
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Duarte, California 91010
959
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East Brunswick, New Jersey 08816
2392
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East Brunswick, NJ
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Elkhorn, Nebraska 68022
1352
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Elkhorn, NE
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Englewood, Colorado 80110
1024
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Evansville, Indiana 47714
1868
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Evansville, IN
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Fort Worth, Texas 76104
1662
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Fountain Hills, Arizona 85628
1115
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Fremont, Nebraska 68025
1336
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Fresno, California 93702
763
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Gaffney, South Carolina 29341
2250
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Glendale, Arizona 85306
1103
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Greensboro, North Carolina 27408
2297
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Greenville, North Carolina 27834
2427
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Greenville, South Carolina 29607
2224
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Greer, South Carolina 29651
2229
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Gurnee, Illinois 60031
1706
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Hawaiian Gardens, California 90716
979
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Henderson, Nevada 89052
889
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Honolulu, Hawaii 96814
2679
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Houston, Texas 77030
1892
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Humble, Texas 77338
1882
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Jacksonville, Florida 32207
2454
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Kalispell, Montana 59901
373
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Kenosha, Wisconsin 53142
1702
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Kerrville, Texas 78028
1729
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Kingsport, Tennessee 37660
2150
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Knoxville, Tennessee 37938
2104
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La Jolla, California 92037
1056
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Lancaster, California 93534
919
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Las Vegas, Nevada 89128
868
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Lawrenceville, New Jersey 08648
2382
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Lexington, Kentucky 40503
2004
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Lomita, California 90717
978
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Los Alamitos, California 90720
981
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Los Angeles, California 90027
956
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Louisville, Kentucky 40213
1944
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1927
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Maumee, OH
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McMurray, Pennsylvania 15317
2134
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Miami, Florida 33136
2730
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Miami Springs, Florida 33166
2725
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Midlothian, Virginia 23114
2343
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Mishawaka, Indiana 46545
1808
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Morehead City, North Carolina 28557
2492
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Moreno Valley, California 92555
987
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Mount Pleasant, South Carolina 29464
2426
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706
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Murray, UT
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Nashua, New Hampshire 03063
2454
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Nashville, Tennessee 37203
1971
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New Braunfels, Texas 78130
1786
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New Orleans, Louisiana 70112
2099
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New Port Richey, Florida 34652
2501
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New Windsor, New York 12553
2376
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New York, New York 10029
2402
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Norfolk, Virginia 23510
2430
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Norman, Oklahoma 73069
1538
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Northport, New York 11768
2426
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Northridge, California 91325
946
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677
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Ogden, UT
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Olympia, Washington 98502
48
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Omaha, Nebraska 68114
1367
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Orlando, Florida 32804
2544
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Ormond Beach, Florida 32174
2527
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Paducah, Kentucky 42003
1852
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Palm Harbor, Florida 34684
2507
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Palm Springs, California 92262
1000
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Pelzer, South Carolina 29669
2230
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Pembroke Pines, Florida 33026
2719
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Peoria, Illinois 61615
1678
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