Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 5:03 AM
Ignite Modification Date:
2025-12-25 @ 5:03 AM
NCT ID:
NCT04698018
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.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
75 Years
Study:
NCT04698018
Study Brief:
Protocol Section:
NCT04698018