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 |
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).
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
sites
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