A Trial Comparing the Safety and Efficacy of Insulin Degludec and Insulin Glargine, Both With Insulin Aspart as Mealtime Insulin in Subjects With Type 1 Diabetes



Status:Completed
Conditions:Diabetes, Diabetes
Therapuetic Areas:Endocrinology
Healthy:No
Age Range:18 - Any
Updated:1/3/2019
Start Date:January 5, 2014
End Date:January 11, 2016

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A Randomised, Double Blind, Cross-over Trial Comparing the Safety and Efficacy of Insulin Degludec and Insulin Glargine, Both With Insulin Aspart as Mealtime Insulin in Subjects With Type 1 Diabetes (SWITCH 1)

This trial is conducted in Europe and the United States of America (USA). The aim of the
trial is to compare the safety and efficacy of insulin degludec (IDeg) and insulin glargine
(IGlar), both with insulin aspart (IAsp) as mealtime insulin in subjects with type 1
diabetes.


Inclusion Criteria: - Subjects fulfilling at least one of the below criteria: a)
Experienced at least one severe hypo episode within the last year (according to the ADA
(American Diabetes Association) definition, April 2013) b) Moderate chronic renal failure,
defined as glomerular filtration rate 30 - 59 mL/min/1.73 m^2 per CKD-Epi (chronic kidney
disease epidemiology collaboration) c) Hypoglycaemic symptom unawareness d) Diabetes
mellitus duration for more than 15 years e) Recent episode of hypoglycaemia (defined by
symptoms of hypoglycaemia and/or episode with low glucose measurement (below or equal to 70
mg/dL [below or equal to 3.9 mmol/L])) within the last 12 weeks prior to Visit 1
(screening) - Male or female, age at least 18 years at the time of signing informed consent
- Type 1 diabetes mellitus (diagnosed clinically) for at least 52 weeks prior to Visit 1 -
Current treatment with a basal-bolus regimen consisting of neutral protamine Hagedorn (NPH)
insulin OD (once daily) / BID (twice daily) or insulin detemir (IDet) OD / BID plus 2-4
daily injections of any rapid acting meal time insulin or CSII (with rapid acting insulin)
for at least 26 weeks prior to Visit 1 - HbA1c (glycosylated haemoglobin) below or equal to
10% by central laboratory analysis - BMI (body mass index) below or equal to 45 kg/m^2
Exclusion Criteria: - Treatment with IGlar or IDeg within the last 26 weeks prior to Visit
1 (short term use [less than or equal to 2 weeks] is allowed, but not within 4 weeks prior
to screening) - Use of any other anti-diabetic agent than those stated in the inclusion
criteria within the last 26 weeks prior to Visit 1
We found this trial at
85
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Fort Lauderdale, Florida 33316
1309
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Albany, New York 12208
1307
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Amarillo, Texas 79106
283
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Anderson, Indiana 46011
668
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Anderson, IN
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Arlington Heights, Illinois 60004
465
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Arlington Heights, IL
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Asheville, North Carolina 28801
857
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Austin, Texas 78731
517
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Austin, TX
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Bialystok,
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Billings, Montana 59101
780
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Birmingham, Alabama 35215
684
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Carrollton, Texas 75007
331
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Chattanooga, Tennessee 37404
721
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Chesapeake, Virginia 23321
1175
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Chicago, Illinois 60612
609
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Concord, California 94520
1316
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Cooper City, Florida 33024
1304
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Council Bluffs, Iowa 51501
264
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Crystal Lake, Illinois 60012
421
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Dallas, Texas 75231
341
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Denver, Colorado 80220
409
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El Paso, Texas 79912
640
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Escondido, California 92025
1128
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Federal Way, Washington 98003
1402
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Fleming Island, Florida 32003
1061
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Fresno, California 93702
1205
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Goodyear, Arizona 85395
868
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Greenville, North Carolina 27834
1140
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Hamilton, New Jersey 08619
1282
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Harrison, New York 10528
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Hazelwood, Missouri 63042
410
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Henderson, Nevada 89052
957
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Hialeah, Florida 33012
1313
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Houston, Texas 77030
572
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Idaho Falls, Idaho 83404
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Indianapolis, Indiana 46260
643
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Jacksonville, Florida 32207
1058
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Jefferson City, Missouri 65109
312
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800 Scudders Mill Road
Jenkintown, Pennsylvania 19046
1254
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Kansas City, Missouri 64106
199
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562
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Katy, TX
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Kingsport, Tennessee 37660
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La Jolla, California 92037
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Las Vegas, Nevada 89128
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Lawrenceville, Georgia 30046
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Lenexa, Kansas 66219
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Lexington, Kentucky 40503
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Livonia, Michigan 48152
827
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Long Beach, California 90807
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Mesquite, Texas 75149
351
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Miami, Florida 33136
1320
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Miami Springs, Florida 33166
1314
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Milwaukee, Wisconsin 53209
636
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Mineola, New York 11501
1305
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Morehead City, North Carolina 28557
1191
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Nashua, New Hampshire 03063
1425
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New Port Richey, Florida 34652
1091
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Norfolk, Virginia 23510
1182
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Oklahoma City, Oklahoma 73112
158
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Omaha, Nebraska 68114
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Pembroke Pines, Florida 33026
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Philadelphia, Pennsylvania 19104
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Pittsburgh, Pennsylvania 15224
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Port Charlotte, Florida 33952
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Port Orange, Florida 32127
1135
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Raleigh, North Carolina 27610
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Rancho Cucamonga, California 91730
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Renton, Washington 98057
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Richardson, Texas 75080
335
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Richland, Washington 99352
1243
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Santa Monica, California 90404
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Skokie, Illinois 60077
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Spokane, Washington 99202
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Sugar Land, Texas 77479
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Syracuse, New York 13210
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Ventura, California 93003
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Walla Walla, Washington 99362
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West Des Moines, Iowa 50265
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