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 @ 10:01 PM
Ignite Modification Date:
2025-12-24 @ 10:01 PM
NCT ID:
NCT07198932
Eligibility Criteria:
Inclusion Criteria:
1. Sign the informed consent form.
2. Aged ≥18 years.
3. Diagnosed with type 2 diabetes mellitus (meeting the 1999 WHO diagnostic criteria).
4. Recently tested HbA1c 7%-9% and FPG ≤11 mmol/L, with stable treatment using insulin ± OADs for at least 12 weeks prior to enrollment. Insulin regimens are limited to: basal insulin once daily or once weekly, premixed insulin once or twice daily, or IDegAsp once or twice daily. OAD classes are limited to metformin, SGLT2 inhibitors, and α-glucosidase inhibitors and with no more than three agents in total.
5. Willing to start or have already initiated cofrogliptin or linagliptin treatment (at the physician's discretion in accordance with clinical practice). The treatment decision is independent of study enrollment, must be made before signing the informed consent, and cofrogliptin or linagliptin initiation must occur either within 2 weeks before or within 2 weeks after signing the informed consent.
Exclusion Criteria:
1. Allergic to the study drug.
2. Diagnosed with type 1 diabetes.
3. Unable to comply with study-specific procedures.
4. Current or planned pregnant, or currently breastfeeding.
5. With any other situation judged by the investigator, that is unsuitable for participation in this trial.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT07198932
Study Brief:
Protocol Section:
NCT07198932