Clinical trial NCT04698018: A Research Study to Look at How Faster Aspart Works in Chinese People With Type 1 Diabetes or Type 2 Diabetes
Official title: A Trial Investigating the Pharmacokinetic Properties of Fast-acting Insulin Aspart in Chinese Subjects With Type 1 Diabetes or Type 2 Diabetes
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Diabetes Mellitus, Type 1
Diabetes Mellitus, Type 2
Lead sponsor: Novo Nordisk A/S
Sponsor class: INDUSTRY
First posted: 2021-01-06
Enrollment: 23
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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.


Eligibility 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.
* Type 1 diabetes mellitus (as diagnosed clinically) greater than or equal to 12 months prior to the day of screening.
* 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.
* 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:

* Male or female Chinese subjects aged 18-75 years (both inclusive) at the time of signing informed consent.
* Type 2 diabetes mellitus (as diagnosed clinically) greater than or equal to 12 months prior to the day of screening.
* 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.
* 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:

* Any disorder, which in the investigator's opinion might jeopardise subject's safety or compliance with the protocol.
* Surgery or trauma with significant blood loss (more than 400 mL) within the last 3 months prior to screening.
* Not able or willing to refrain from smoking and use of nicotine substitute products during the in-patient period.

Primary outcomes:
measure: AUCIAsp,0-30min, area under the serum insulin aspart concentration-time curve from 0 to 30 minutes
timeFrame: 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)
Secondary outcomes:
measure: AUCIAsp,0-15min, area under the serum insulin aspart concentration-time curve from 0 to 15 minutes
timeFrame: 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)
measure: AUCIAsp,0-1h, area under the serum insulin aspart concentration-time curve from 0 to 1 hour
timeFrame: 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)
measure: AUCIAsp,0-1½h, area under the serum insulin aspart concentration-time curve from 0 to 1½ hours
timeFrame: 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)
measure: AUCIAsp,0-2h, area under the serum insulin aspart concentration-time curve from 0 to 2 hours
timeFrame: 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)
measure: AUCIAsp,0-12h, area under the serum insulin aspart concentration-time curve from 0 to 12 hours
timeFrame: 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)
measure: Cmax,IAsp, maximum observed serum insulin aspart concentration
timeFrame: 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)
measure: tmax,IAsp, time to maximum observed serum insulin aspart concentration
timeFrame: 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)
measure: 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)
timeFrame: 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)
measure: Time to 50 percent Cmax, IAsp, the first time point where the insulin aspart concentration equals 50 percent of Cmax,IAsp
timeFrame: 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)
measure: Time to late 50 percent Cmax,IAsp, the last time point where the insulin aspart concentration equals 50 percent of Cmax,IAsp
timeFrame: 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)
measure: t½, terminal half-life for insulin aspart
timeFrame: 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)
measure: Number of treatment emergent adverse events
timeFrame: Until 7 days after IMP (investigational medicinal product) administration
measure: Number of treatment emergent hypoglycaemic episodes
timeFrame: No longer than 16 hours after IMP administration until next administration of insulin (non-investigational medicinal product (NIMP) or subject's pre-trial insulin)
Other outcomes:
Locations:
city: Neuss
country: Germany
facility: Profil Institut für Stoffwechselforschung GmbH
city: Shatin, New Territories, Hong Kong
country: Hong Kong
facility: Phase 1 Clinical Trial Centre
city: Shatin, New Territories
country: Hong Kong
facility: Phase 1 Clinical Trial Centre
Study officials:
affiliation: Novo Nordisk A/S
name: Clinical Transparency (1452)
role: STUDY_DIRECTOR
References: