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).
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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
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Bennington, Vermont 05201
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Boynton Beach, Florida 33472
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Chesapeake, Virginia 23321
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Chicago, Illinois 60612
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Concord, California 94520
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Green Bay, Wisconsin 54303
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