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
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East Brunswick, New Jersey 08816
456
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Albany, New York 12208
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Albuquerque, New Mexico 87102
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Amarillo, Texas 79106
1078
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Anderson, South Carolina 29621
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Anniston, Alabama 36207
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Arlington, Texas 76012
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Austin, Texas 78731
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Beaver, Pennsylvania 15009
151
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Bennington, Vermont 05201
547
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Birmingham, Alabama 35215
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Blackfoot, Idaho 83221
1523
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Bloomfield Hills, Michigan 48302
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Bountiful, Utah 84010
1512
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Bradenton, Florida 34201
868
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Brandon, Florida 33511
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Bristol, Tennessee 37620
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Chandler, Arizona 85224
1655
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Charlotte, North Carolina 28277
348
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Chattanooga, Tennessee 37404
362
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Chesapeake, Virginia 23321
418
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Chesterfield, Missouri 63017
413
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Chicago, Illinois 60612
274
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Clearwater, Florida 33756
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Colorado Springs, Colorado 80910
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Columbus, Ohio 43205
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Concord, California 94520
2081
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Cooper City, Florida 33024
973
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Council Bluffs, Iowa 51501
678
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Dakota Dunes, South Dakota 57049
720
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Dallas, Texas 75231
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Downey, California 90242
1969
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Duarte, California 91010
1955
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Elkhorn, Nebraska 68022
698
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Englewood, Colorado 80110
1163
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Evansville, Indiana 47714
278
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Fort Worth, Texas 76104
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Fountain Hills, Arizona 85628
1639
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Fremont, Nebraska 68025
711
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Fresno, California 93702
1988
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Gaffney, South Carolina 29341
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Glendale, Arizona 85306
1662
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Greensboro, North Carolina 27408
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Greenville, North Carolina 27834
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Greenville, South Carolina 29607
354
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Greer, South Carolina 29651
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Gurnee, Illinois 60031
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Hawaiian Gardens, California 90716
1969
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Henderson, Nevada 89052
1755
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Honolulu, Hawaii 96814
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995
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Kalispell, Montana 59901
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Kenosha, Wisconsin 53142
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Kerrville, Texas 78028
1137
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Kingsport, Tennessee 37660
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Knoxville, Tennessee 37938
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La Jolla, California 92037
1954
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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
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Lomita, California 90717
1982
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Los Alamitos, California 90720
1969
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Los Angeles, California 90027
1973
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Louisville, Kentucky 40213
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Marietta, Georgia 30060
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McMurray, Pennsylvania 15317
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Miami, Florida 33136
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Miami Springs, Florida 33166
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Midlothian, Virginia 23114
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Mishawaka, Indiana 46545
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Morehead City, North Carolina 28557
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Moreno Valley, California 92555
1922
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Mount Pleasant, South Carolina 29464
525
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1514
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Nashua, New Hampshire 03063
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Nashville, Tennessee 37203
333
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New Braunfels, Texas 78130
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New Port Richey, Florida 34652
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Norfolk, Virginia 23510
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Northridge, California 91325
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Olympia, Washington 98502
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Orlando, Florida 32804
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Ormond Beach, Florida 32174
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Paducah, Kentucky 42003
361
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Palm Harbor, Florida 34684
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Palm Springs, California 92262
1888
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Pelzer, South Carolina 29669
369
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Pembroke Pines, Florida 33026
978
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Peoria, Illinois 61615
349
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