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 @ 5:07 AM
Ignite Modification Date:
2025-12-25 @ 5:07 AM
NCT ID:
NCT05717127
Eligibility Criteria:
Inclusion Criteria:
* Men and women with type 2 diabetes mellitus diagnosed within preceding 10 years
* Age 20-70 years inclusive
* Body mass index ≥ 25 kg/m2
* Diabetes treatment consisting of lifestyle only, metformin or dipeptidyl peptidase-4 (DPP-4) inhibitor either as monotherapy or in combination
* HbA1c value of 5.5 - 9.0% inclusive
Exclusion Criteria:
* Current diabetes treatment with insulin, glucagon-like peptide-1 receptor agonists, sodium-glucose co-transporter 2 (SGLT-2) and/or sulfonylureas
* Involvements in any other clinical study on lifestyle intervention or requiring drug therapy
* Any history or eating disorder
* Renal dysfunction as evidenced by estimated glomerular filtration rate \<45 mL/min by Modification of Diet in Renal Disease (MDRD) formula
* Hepatic disease considered to be clinically significant (includes jaundice, chronic hepatitis, or previous liver transplant) or transaminases \>2.5x the upper limit of normal
* Malignant neoplasm requiring chemotherapy, surgery, radiation or palliative therapy within the previous 5 years (with the exception of basal cell skin cancer)
* Any other factor likely to limit adherence to the study, in the opinion of the investigators
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
20 Years
Maximum Age:
70 Years
Study:
NCT05717127
Study Brief:
Protocol Section:
NCT05717127