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 @ 10:00 PM
Ignite Modification Date:
2025-12-24 @ 10:00 PM
NCT ID:
NCT05359432
Eligibility Criteria:
Inclusion Criteria:
Female and Male Patients of age 30-65 years with confirmed diagnosis of "type 2 diabetes mellitus".
Uncontrolled type 2 diabetes mellitus (\> 7% HbA1c patients on monotherapy of metformin for the past three months on a fixed dose of 1500 mg /day along with lifestyle modifications were included in this study.
BMI ranges from 18-45 kg/m2 were considered fit for this study. eGFR ≥ 60 ml/min/1.73 m2
Exclusion Criteria:
Pregnant female or female patients planning to conceive during the study period were excluded from this study.
"Type 1 diabetes" or "secondary diabetes" resulting from specific causes Patients with advanced diabetic complications. Patients with any other terminal disease(s) requiring long-term medications. Patients involved in other trials on therapy with SGLT-2i or DPP4-I 3 months before study enrollment Patients on insulin or any other oral hypoglycemic drugs except metformin. Serum creatinine levels ≥ 1.3 mg/dl in women and ≥ 1.4 mg/dl in men
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
30 Years
Maximum Age:
65 Years
Study:
NCT05359432
Study Brief:
Protocol Section:
NCT05359432