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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Spokane, Washington 99202
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Albany, New York 12208
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Albuquerque, New Mexico 87102
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Amarillo, Texas 79106
283
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Anderson, South Carolina 29621
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Anniston, Alabama 36207
728
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Arlington, Texas 76012
347
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Austin, Texas 78731
517
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Beaver, Pennsylvania 15009
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Bennington, Vermont 05201
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Birmingham, Alabama 35215
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Blackfoot, Idaho 83221
849
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Bloomfield Hills, Michigan 48302
837
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Bountiful, Utah 84010
781
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Bradenton, Florida 34201
1142
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Brandon, Florida 33511
1125
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Bristol, Tennessee 37620
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Calgary,
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Chandler, Arizona 85224
846
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Charlotte, North Carolina 28277
957
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Chattanooga, Tennessee 37404
721
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Chesapeake, Virginia 23321
1175
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Chesterfield, Missouri 63017
398
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Chicago, Illinois 60612
609
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Clearwater, Florida 33756
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Colorado Springs, Colorado 80910
383
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Columbus, Ohio 43205
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Concord, California 94520
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Cooper City, Florida 33024
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Council Bluffs, Iowa 51501
264
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Dakota Dunes, South Dakota 57049
334
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Dallas, Texas 75231
341
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Downey, California 90242
1165
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Duarte, California 91010
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East Brunswick, New Jersey 08816
1266
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Elkhorn, Nebraska 68022
258
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Englewood, Colorado 80110
407
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Evansville, Indiana 47714
561
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Fort Worth, Texas 76104
348
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Fountain Hills, Arizona 85628
829
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Fremont, Nebraska 68025
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Fresno, California 93702
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Gaffney, South Carolina 29341
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Glendale, Arizona 85306
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Greensboro, North Carolina 27408
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Greenville, North Carolina 27834
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Greenville, South Carolina 29607
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Greer, South Carolina 29651
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Gurnee, Illinois 60031
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Hawaiian Gardens, California 90716
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Henderson, Nevada 89052
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Honolulu, Hawaii 96814
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Houston, Texas 77030
572
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Humble, Texas 77338
555
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Jacksonville, Florida 32207
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Kenosha, Wisconsin 53142
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Kerrville, Texas 78028
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Kingsport, Tennessee 37660
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La Jolla, California 92037
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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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Mishawaka, Indiana 46545
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Moreno Valley, California 92555
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Mount Pleasant, South Carolina 29464
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778
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Nashua, New Hampshire 03063
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Nashville, Tennessee 37203
618
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New Braunfels, Texas 78130
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New Orleans, Louisiana 70112
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New Port Richey, Florida 34652
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New Windsor, New York 12553
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Pelzer, South Carolina 29669
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Pembroke Pines, Florida 33026
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