A Research Study to Look at How Faster Aspart Works in Chinese People With Type 1 Diabetes or Type 2 Diabetes
NCT04698018 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 23
Last updated 2025-12-04
Summary
This study looks at how faster aspart reaches and stays in the blood after injection in Chinese people with type 1 diabetes or type 2 diabetes, compared to the reference product called NovoRapid®. Participants will get both faster aspart and NovoRapid®. The order in which Participants get them is decided by chance. Participants will get each study medicine once during the study meaning that they will get a total of 2 injections with study medicines. The medicine will be injected under the skin of the lower abdomen. The study will last for about 19-72 days. Participants will have 5 clinic visits with the study doctor (including the one in which participants give their consent). Participants will need to stay overnight for 2 of the 5 clinic visits. Participants will have blood samples taken during some of the clinic visits. During the visits where participants get the study medicines, samples of their blood will be taken several times for up to 12 hours after getting the study medicine.
Conditions
- Diabetes Mellitus, Type 1
- Diabetes Mellitus, Type 2
Interventions
- DRUG
-
Faster Aspart
Administered s.c. (subcutaneously, under the skin) of the lower abdomen using a pen-injector.
- DRUG
-
Novo Rapid
Administered s.c. (subcutaneously, under the skin) of the lower abdomen using a pen-injector.
Sponsors & Collaborators
- lead INDUSTRY
Principal Investigators
-
Clinical Transparency (1452) · Novo Nordisk A/S
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- QUADRUPLE
- Model
- CROSSOVER
Eligibility
- Min Age
- 18 Years
- Max Age
- 75 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2021-04-20
- Primary Completion
- 2022-07-20
- Completion
- 2022-07-22
- FDA Drug
- Yes
Countries
- Germany
- Hong Kong
Study Locations
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