Status:
COMPLETED
A Research Study to Look at How Faster Aspart Works in Chinese People With Type 1 Diabetes or Type 2 Diabetes
Lead Sponsor:
Novo Nordisk A/S
Conditions:
Diabetes Mellitus, Type 1
Diabetes Mellitus, Type 2
Eligibility:
All Genders
18-75 years
Phase:
PHASE1
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®. Par...
Eligibility Criteria
Inclusion
- 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.
Exclusion
Key Trial Info
Start Date :
April 20 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 22 2022
Estimated Enrollment :
23 Patients enrolled
Trial Details
Trial ID
NCT04698018
Start Date
April 20 2021
End Date
July 22 2022
Last Update
December 4 2025
Active Locations (3)
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1
Profil Institut für Stoffwechselforschung GmbH
Neuss, Germany, 41460
2
Phase 1 Clinical Trial Centre
Shatin, New Territories, Hong Kong, Hong Kong, Postal Code: NA
3
Phase 1 Clinical Trial Centre
Shatin, New Territories, Hong Kong