A Research Study to Look at How Faster Aspart Works in Chinese People With Type 1 Diabetes or Type 2 Diabetes
- Conditions
- Diabetes Mellitus, Type 1Diabetes Mellitus, Type 2
- Interventions
- Drug: Novo Rapid
- Registration Number
- NCT04698018
- Lead Sponsor
- Novo Nordisk A/S
- Brief 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 23
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description Faster aspart Faster Aspart Subjects will receive 2 injections of a single dose of faster aspart at a predefined fixed dose level (0.2 U/kg body weight) for type 1 diabetes and (0.3 U/kg body weight) if subject has type 2 diabetes. NovoRapid® Novo Rapid Subjects will receive 2 injections of a single dose of NovoRapid® at a predefined fixed dose level (0.2 U/kg body weight) for type 1 diabetes and (0.3 U/kg body weight) if subject has type 2 diabetes.
- Primary Outcome Measures
Name Time Method AUCIAsp,0-30min, area under the serum insulin aspart concentration-time curve from 0 to 30 minutes 0 to 12 hours after dosing on Day 2 of Visit 2 (3-21 days after screening) and Visit 3 (7-28 days after visit 2, day 2) pmol·h/L
- Secondary Outcome Measures
Name Time Method AUCIAsp,0-1h, area under the serum insulin aspart concentration-time curve from 0 to 1 hour 0 to 12 hours after dosing on Day 2 of Visit 2 (3-21 days after screening) and Visit 3 (7-28 days after visit 2, day 2) pmol·h/L
Onset of appearanceIAsp, time from trial product administration until the first time serum insulin aspart concentration greater than or equal to lower limit of quantification (LLOQ) 0 to 12 hours after dosing on Day 2 of Visit 2 (3-21 days after screening) and Visit 3 (7-28 days after visit 2, day 2) Minutes
Time to 50 percent Cmax, IAsp, the first time point where the insulin aspart concentration equals 50 percent of Cmax,IAsp 0 to 12 hours after dosing on Day 2 of Visit 2 (3-21 days after screening) and Visit 3 (7-28 days after visit 2, day 2) Minutes
AUCIAsp,0-15min, area under the serum insulin aspart concentration-time curve from 0 to 15 minutes 0 to 12 hours after dosing on Day 2 of Visit 2 (3-21 days after screening) and Visit 3 (7-28 days after visit 2, day 2) pmol·h/L
AUCIAsp,0-2h, area under the serum insulin aspart concentration-time curve from 0 to 2 hours 0 to 12 hours after dosing on Day 2 of Visit 2 (3-21 days after screening) and Visit 3 (7-28 days after visit 2, day 2) pmol·h/L
AUCIAsp,0-12h, area under the serum insulin aspart concentration-time curve from 0 to 12 hours 0 to 12 hours after dosing on Day 2 of Visit 2 (3-21 days after screening) and Visit 3 (7-28 days after visit 2, day 2) pmol·h/L
Cmax,IAsp, maximum observed serum insulin aspart concentration 0 to 12 hours after dosing on Day 2 of Visit 2 (3-21 days after screening) and Visit 3 (7-28 days after visit 2, day 2) pmol/L
Time to late 50 percent Cmax,IAsp, the last time point where the insulin aspart concentration equals 50 percent of Cmax,IAsp 0 to 12 hours after dosing on Day 2 of Visit 2 (3-21 days after screening) and Visit 3 (7-28 days after visit 2, day 2) Minutes
AUCIAsp,0-1½h, area under the serum insulin aspart concentration-time curve from 0 to 1½ hours 0 to 12 hours after dosing on Day 2 of Visit 2 (3-21 days after screening) and Visit 3 (7-28 days after visit 2, day 2) pmol·h/L
tmax,IAsp, time to maximum observed serum insulin aspart concentration 0 to 12 hours after dosing on Day 2 of Visit 2 (3-21 days after screening) and Visit 3 (7-28 days after visit 2, day 2) Minutes
t½, terminal half-life for insulin aspart 0 to 12 hours after dosing on Day 2 of Visit 2 (3-21 days after screening) and Visit 3 (7-28 days after visit 2, day 2) Minutes
Number of treatment emergent adverse events Until 7 days after IMP (investigational medicinal product) administration Count of Events
Number of treatment emergent hypoglycaemic episodes No longer than 16 hours after IMP administration until next administration of insulin (non-investigational medicinal product (NIMP) or subject's pre-trial insulin) Count of Episodes
Trial Locations
- Locations (2)
Profil Institut für Stoffwechselforschung GmbH
🇩🇪Neuss, Germany
Phase 1 Clinical Trial Centre
🇭🇰Shatin, New Territories, Hong Kong