Research Study Comparing a New Medicine "Fast-acting Insulin Aspart" to Another Already Available Medicine "NovoRapid"/"NovoLog" in People With Type 2 Diabetes



Status:Completed
Conditions:Diabetes, Diabetes
Therapuetic Areas:Endocrinology
Healthy:No
Age Range:18 - Any
Updated:2/13/2019
Start Date:September 19, 2017
End Date:January 29, 2019

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Efficacy and Safety of Fast-acting Insulin Aspart Compared to NovoRapid® Both in Combination With Insulin Degludec With or Without Metformin in Adults With Type 2 Diabetes (Onset® 9)

The study compares 2 medicines for type 2 diabetes: fast-acting insulin aspart (a new
medicine) and NovoRapid®/NovoLog® (a medicine doctors can already prescribe). Fast-acting
insulin aspart will be tested to see how well it works and if it is safe. Participants will
get either fast-acting insulin aspart or NovoRapid®/ NovoLog® - which treatment you get is
decided by chance. Both medicines will be taken together with insulin degludec. Participants
will need to take 1 injection 4 times every day (all insulins will be provided in pens). The
study will last for about 8 months (34 weeks).


Inclusion Criteria: - Male or female, age equal to or above 18 years at the time of signing
informed consent. - Diagnosed with type 2 diabetes mellitus for 10 years or longer prior to
screening (Visit 1). - Treated with a basal-bolus insulin regimen for 1 year or longer
prior to the day of screening (Visit 1). A basal-bolus insulin regimen is defined as basal
insulin once or twice daily and bolus insulin analogue taken with meals at least 3 times
daily. Treatment with premixed insulin or soluble insulin combination is not considered a
basal-bolus regimen. - Treated with or without oral antidiabetic drugs including extended
release formulations. - HbA1c 7.0-10.0% (both inclusive) as assessed by central laboratory
at screening (Visit 1). Exclusion Criteria: - Any of the following: myocardial infarction,
stroke, hospitalization for unstable angina or transient ischaemic attack within the past
180 days prior to the day of screening (Visit 1). - Subjects presently classified as being
in New York Heart Association (NYHA) Class IV. - Planned coronary, carotid or peripheral
artery revascularisation known on the day of screening (Visit 1). - Treatment with
injectable GLP-1 receptor agonists in a period of 90 days prior to screening (Visit 1). -
Anticipated initiation or change in concomitant medications (for more than 14 consecutive
days) known to affect weight or glucose metabolism (e.g. treatment with orlistat, thyroid
hormones, or corticosteroids).
We found this trial at
60
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Amarillo, Texas 79106
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Asheville, North Carolina 28801
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Atlanta, Georgia 30318
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Austin, Texas 78731
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Beaumont, Texas 77701
1925
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Bennington, Vermont 05201
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Boynton Beach, Florida 33472
2701
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Bradenton, Florida 34201
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Caba,
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Chapel Hill, North Carolina 27599
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Chattanooga, Tennessee 37404
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Chesapeake, Virginia 23321
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Chicago, Illinois 60612
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Concord, California 94520
663
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Dallas, Texas 75231
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Denver, Colorado 80220
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Des Moines, Iowa 50314
1462
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Fort Lauderdale, Florida 33316
2719
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Fresno, California 93702
763
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Fullerton, California 92835
978
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Golden, Colorado 80401
1010
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Green Bay, Wisconsin 54303
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Greenville, South Carolina 29607
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Henderson, Nevada 89052
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Honolulu, Hawaii 96814
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Lancaster, California 93534
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Las Vegas, Nevada 89128
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Lawrenceville, Georgia 30046
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Lexington, Kentucky 40503
2004
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Longview, Texas 75605
1779
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2032
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Mentor, OH
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Miami, Florida 33136
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Nashua, New Hampshire 03063
2454
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Nashville, Tennessee 37203
1971
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Norco, California 92860
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Northport, New York 11768
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Oklahoma City, Oklahoma 73112
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Olympia, Washington 98502
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Pearland, Texas 77584
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Peoria, Illinois 61615
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Philadelphia, Pennsylvania 19104
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Rockville, Maryland 20852
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Roswell, Georgia 30076
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Round Rock, Texas 78681
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Sacramento, California 95821
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Seattle, Washington 98105
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South Burlington, Vermont 05403
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Spokane, Washington 99202
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Springfield, Illinois 62702
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Tampa, Florida 33612
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Topeka, Kansas 66606
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Valparaiso, Indiana 46383
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Ventura, California 93003
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Walnut Creek, California 94598
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Waltham, Massachusetts 02453
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Waterbury, Connecticut 06708
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West Seneca, New York 14224
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Winchester, Virginia 22601
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Worcester, Massachusetts 01655
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