Ignite Creation Date:
2025-12-24 @ 2:32 PM
Ignite Modification Date:
2025-12-28 @ 7:37 PM
Study NCT ID:
NCT04588259
Status:
COMPLETED
Last Update Posted:
2025-12-04
First Post:
2020-10-09
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Research Study to Compare a New Medicine "Fast-acting Insulin Aspart" to Another Medicine "Insulin Aspart" in Chinese People With Diabetes
Sponsor:
Novo Nordisk A/S
Organization:
Study Overview
Official Title:
Efficacy and Safety of Fast-acting Insulin Aspart Compared to NovoRapid® Both in Combination With Insulin Degludec With or Without Metformin in Adults With Diabetes
Status:
COMPLETED
Status Verified Date:
2025-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Fast-acting insulin aspart (faster aspart) will be tested to see how well it works and if it is safe. The study compares 2 medicines for type 1 and type 2 diabetes - faster aspart (a new medicine) and insulin aspart (a medicine doctors can already prescribe). Participants will either get faster aspart or insulin aspart (NovoRapid®) - which treatment is decided by chance. Both medicines will be taken together with insulin degludec. Participants will need to take 1 injection 4 times every day: 3 injections 0-2 minutes before breakfast, lunch and dinner and 1 injection at the same time every day. All study medicines are provided in pens. A pen is a tool to inject insulin under the skin.The study will last for about 7 months (30 weeks). Participants will have 11 clinic visits and 17 phone contacts with the study doctor. At 8 clinic visits participants will have blood samples taken. At 3 clinic visits participants cannot eat or drink (water is allowed) 8 hours before the visits - at 2 of these visits participants will be asked to drink a liquid meal and to stay at the clinic for about 5 hours. Participants will fill in a diary the last 3 days before the visits/phone contacts. Women cannot take part if pregnant, breast-feeding or planning to become pregnant during the study period.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| U1111-1197-8289 | OTHER | World Health Organization (WHO) | View |