Trials / Completed
CompletedNCT03268005
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)
- Status
- Completed
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 1,264 (actual)
- Sponsor
- Novo Nordisk A/S · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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).
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Faster-acting insulin aspart | Faster aspart given subcutaneously (s.c., under the skin) once a day for 16 weeks. Dose individually adjusted. |
| DRUG | Insulin aspart | Insulin aspart given subcutaneously (s.c., under the skin) once a day for 16 weeks. Dose individually adjusted. |
| DRUG | Insulin degludec | Insulin degludec given subcutaneously (s.c., under the skin) once a day for 16 weeks. Dose individually adjusted. |
| DRUG | Metformin | Only participants who took metformin before the study should take metformin tablets, same dose as before the study |
Timeline
- Start date
- 2017-09-19
- Primary completion
- 2019-01-07
- Completion
- 2019-01-29
- First posted
- 2017-08-31
- Last updated
- 2022-01-11
- Results posted
- 2020-03-12
Locations
167 sites across 18 countries: United States, Argentina, Bulgaria, Canada, Croatia, Czechia, Germany, Greece, Italy, Poland, Puerto Rico, Romania, Russia, Serbia, Slovakia, South Korea, Spain, Ukraine
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT03268005. Inclusion in this directory is not an endorsement.