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 @ 11:58 PM
Ignite Modification Date:
2025-12-24 @ 11:58 PM
NCT ID:
NCT05833958
Eligibility Criteria:
Inclusion Criteria:
1. Aged ≥18 years;
2. Diagnosis of Type 2 Diabetes (T2D) within 24 months;
3. Drug naïve or using metformin monotherapy at ≤1g daily;
4. Body mass index between 18.5 and 45 kg/m2;
5. HbA1c ≥6.0% (metformin monotherapy) or ≥6.5% (drug naïve), and ≤12%;
6. eGFR ≥45 ml/min/1.73m2;
7. Signed informed consent; and
8. Willingness to take a pregnancy test prior to starting treatment (participants of childbearing potential).
Exclusion Criteria:
1. There is a definite contraindication to either metformin, SGLT2 inhibitors or Dipeptidyl-peptidase 4 (DPP4) inhibitors;
2. There is a definite indication for an SGLT2 inhibitor;
3. A known situation where medication might be altered for a significant length of time (e.g., planned surgery);
4. Moderate or severe anaemia (Hb\< 100g/L women and \<110g/L in men), haemolytic anaemia or known haemoglobinopathy (which may affect the accurate measurement of HbA1c);
5. Unlikely to complete the trial, adhere to the trial or complete study contacts, including at-home pathology tests, according to investigator judgement; or
6. Known or suspected pregnancy or breast-feeding;
7. Participants of childbearing potential (participants who are anatomically and physiologically capable of becoming pregnant), or have a partner of childbearing potential, not willing to use highly effective contraceptive for the 16-week duration of the trial, and who do not confirm a negative pregnancy test before starting the drug;
8. Any severe acute or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with study participation or investigational product administration or may interfere with the interpretation of study results and, in the judgement of the Investigator, and in discussion with the Medical Monitor, would make the participant inappropriate for entry into this study.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT05833958
Study Brief:
Protocol Section:
NCT05833958