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:
2025-12-26 @ 11:13 PM
Ignite Modification Date:
2025-12-26 @ 11:13 PM
NCT ID:
NCT05373212
Eligibility Criteria:
Inclusion Criteria:
* Type 2 diabetes mellitus (as diagnosed clinically) for ≥ 12 months
* HbA1c ≤9.0%
* Total insulin dose of \< 1.2 U/kg/day
* Body mass index between 20.0 and 35.0 kg/m2 (both inclusive)
* Treated with a stable insulin regimen for ≥ 3 months prior to screening
Exclusion Criteria:
* Known or suspected hypersensitivity to the IMPs or any of the excipients or to any component of the IMP formulation
* Receipt of any medicinal product in clinical development within 30 days or at least 5 half-lives of the related substances and their metabolites (whichever is longer) before randomisation in this trial
* Clinically significant abnormal screening laboratory tests, as judged by the Investigator considering the underlying disease
* Clinically relevant comorbidity, capable of constituting a risk for the subject when participating in the trial or of interfering with the interpretation of data
* Systolic blood pressure \< 90 mmHg or \>160 mmHg and/or diastolic blood pressure \< 50 mmHg or \> 95 mmHg (one repeat test will be acceptable in case of suspected white-coat hypertension)
* Heart rate at rest outside the range of 50-90 beats per minute
* Use of GLP-1 receptor agonists or oral antidiabetic drugs (OADs) other than stable intake of metformin within 4 weeks prior to screening
* Women of childbearing potential who are not using a highly effective contraceptive method
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
64 Years
Study:
NCT05373212
Study Brief:
Protocol Section:
NCT05373212