A Research Study to Look at How Faster Aspart Works in Chinese People With Type 1 Diabetes or Type 2 Diabetes
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 1 |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: 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. |
Drug: Faster Aspart
Administered s.c. (subcutaneously, under the skin) of the lower abdomen using a pen-injector.
|
| Active Comparator: NovoRapid® 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. |
Drug: Novo Rapid
Administered s.c. (subcutaneously, under the skin) of the lower abdomen using a pen-injector.
|
Outcome Measures
Primary Outcome Measures
- 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
- 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,0-1h, 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
- 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
- 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
- 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
- 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
- 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
- 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
Eligibility Criteria
Criteria
Inclusion criteria:
For a subject with type 1 diabetes mellitus:
-
Male or female Chinese subjects aged 18-64 years (both inclusive) at the time of signing informed consent.
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Type 1 diabetes mellitus (as diagnosed clinically) greater than or equal to 12 months prior to the day of screening.
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Treated with multiple daily insulin injections or premix insulin greater than or equal to 12 months prior to the day of screening or treated with continuous subcutaneous insulin infusion (CSII) greater than or equal to 3 months prior to the day of screening.
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Glycosylated haemoglobin (HbA1c) less than or equal to 9.0 percent (75 mmol/mol) by central laboratory analysis.
For a subject with type 2 diabetes mellitus:
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Male or female Chinese subjects aged 18-75 years (both inclusive) at the time of signing informed consent.
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Type 2 diabetes mellitus (as diagnosed clinically) greater than or equal to 12 months prior to the day of screening.
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Treated with multiple daily insulin injections or premix insulin greater than or equal to 6 months prior to the day of screening or treated with continuous subcutaneous insulin infusion (CSII) greater than or equal to 3 months prior to the day of screening.
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Glycosylated haemoglobin less than or equal to 9.5 percent (80 mmol/mol) by central laboratory analysis.
Exclusion criteria:
For a subject with type 1 diabetes mellitus or type 2 diabetes mellitus:
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Any disorder, which in the investigator's opinion might jeopardise subject's safety or compliance with the protocol.
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Surgery or trauma with significant blood loss (more than 400 mL) within the last 3 months prior to screening.
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Not able or willing to refrain from smoking and use of nicotine substitute products during the in-patient period.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Novo Nordisk Investigational Site | Shatin, New Territories | Hong Kong |
Sponsors and Collaborators
- Novo Nordisk A/S
Investigators
- Study Director: Clinical Transparency (1452), Novo Nordisk A/S
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- NN1218-4316
- U1111-1199-1934