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NCT03268005Completed

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

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)
Novo Nordisk A/SPhase 3ClinicalTrials.govdrug
Verified
Study focus
Disease/Condition
Diabetes,Diabetes Mellitus, Type 2
Drug/Device/Intervention
Faster-acting insulin aspart
Study type
Interventional
Intervention type
drug
Sponsor & location
Primary sponsor
Novo Nordisk A/S
Location
Concord,Fresno,Fullerton,Lancaster,Norco,Sacramento,Ventura,Walnut Creek,Denver,Golden,Waterbury,Boynton Beach,Bradenton,Fort Lauderdale,Miami,Tampa,Alpharetta,Lawrenceville,Roswell,Honolulu,Chicago,P, Argentina,Bulgaria,Canada,Croatia,Czech,Germany,Greece,Italy,South Korea,Poland,Puerto Rico,Romania,
Timeline & enrollment
Phase
Phase 3
Start date
Sep 19, 2017
End date
Jan 29, 2019
Enrollment
1264 participants
Primary outcome

Change in Glycosylated Haemoglobin (HbA1c)

Summary

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).

ICD-10 classifications
Type 2 diabetes mellitusType 2 diabetes mellitus with other specified complicationsType 2 diabetes mellitus with unspecified complicationsType 2 diabetes mellitus without complicationsType 2 diabetes mellitus with multiple complications
Data source
Registry
ClinicalTrials.gov
Trial ID
NCT03268005
Type
Non-Device Trial
About this record

Access comprehensive clinical trial information for NCT03268005 through Pure Global AI's free database. This Phase 3 trial is sponsored by Novo Nordisk A/S and is currently Completed. The study focuses on Diabetes,Diabetes Mellitus, Type 2. Target enrollment is 1264 participants.

This page provides complete trial specifications, intervention details, outcomes, and location information. Pure Global AI offers free access to ClinicalTrials.gov data, helping medical device and pharmaceutical companies navigate clinical research efficiently.