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Research Study Comparing a New Medicine Fast-acting Insulin Aspart to Another Already Available Medicine NovoRapid/NovoLog in People With Type 2 Diabetes - Trial NCT03268005

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.

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NCT03268005
Phase 3
Completed
drug
Trial Details
ClinicalTrials.gov • NCT03268005
View on ClinicalTrials.gov
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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)

Study Focus

Faster-acting insulin aspart

Interventional

drug

Sponsor & Location

Novo Nordisk A/S

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 3

Sep 19, 2017

Jan 29, 2019

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 mellitus
Type 2 diabetes mellitus with other specified complications
Type 2 diabetes mellitus with unspecified complications
Type 2 diabetes mellitus without complications
Type 2 diabetes mellitus with multiple complications

Data Source

ClinicalTrials.gov

NCT03268005

Non-Device Trial