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:
2025-12-24 @ 1:12 PM
Ignite Modification Date:
2025-12-24 @ 1:12 PM
NCT ID:
NCT07068295
Eligibility Criteria:
Inclusion Criteria:
* Male or female (sex at birth).
* Age 18-69 years (both inclusive) at the time of signing the informed consent.
* Diagnosed with Type 2 Diabetes (T2D) greater than or equal to (≥) 180 days before screening.
* Treated with any injectable insulin, except once-weekly insulin, ≥ 180 days before screening.
* Current daily insulin treatment between 0.2 and 1.2 Insulin units per kilogram per day \[(I) U/kg/day\] (both inclusive) with or without the following anti-diabetic drugs with stable doses ≥ 90 days prior to the day of screening:
* Any metformin formulation
* Dipeptidyl peptidase-4 inhibitor (DPP4i)
* Sodium-glucose Cotransporter-2 inhibitor (SGLT2i)
* Body mass index (BMI) between 18.5 and 34.9 kg/m2 (both inclusive) at screening.
* HbA1c lesser than or equal to (≤) 9.5%
Exclusion Criteria:
* Known or suspected hypersensitivity to study intervention(s) or related products.
* Female who is pregnant, breast-feeding or intends to become pregnant or is of child-bearing potential and not using adequate contraceptive methods.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
69 Years
Study:
NCT07068295
Study Brief:
Protocol Section:
NCT07068295