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 @ 3:39 PM
Ignite Modification Date:
2025-12-24 @ 3:39 PM
NCT ID:
NCT06095492
Eligibility Criteria:
Inclusion Criteria:
1. A man or woman, 30 years of age or above with the diagnosis of diabetes mellitus (pre-transplantation type 2 diabetes or post-transplantation diabetes mellitus) and after at least 3 months of renal transplantation.
2. Patients must have stable renal function (less than 20% deviation in serum creatinine in last one month: eGFR \>30 ml/min/1.73 m2)
3. Patients must be on a stable immunotherapy for last one month.
4. Subjects must be medically stable on the basis of medical history, physical examination and laboratory investigations.
5. Subjects must be willing and able to adhere to the prohibitions and restrictions specified in this protocol.
6. Each subject must sign an informed consent form (ICF) indicating that he or she understands the purpose of the study and are willing to participate in the study.
Exclusion Criteria:
1. History of diabetic ketoacidosis, type 1 diabetes, pancreas or beta-cell transplantation, or diabetes secondary to pancreatitis or pancreatectomy.
2. History of brittle or labile glycemic control, with widely varying glucose measurements by FPG or SMBG such that stable glucose control over the treatment period would be unlikely.
3. BMI \<=18 kg/m2
4. Ongoing eating disorder, or a significant weight loss or weight gain within 12 weeks before the Screening visit, defined as an increase or decrease of 5% in body weight based upon clinic-based measurement or, if not available, based on subject's report.
5. Estimated glomerular filtration rate (eGFR) \<30 mL/min/1•73 m2 using the Modification of Diet in Renal Disease Study (MDRD) equation.
6. Contraindications to the use of empagliflozin or linagliptin (per Prescribing Information).
7. History of recurrent urinary tract infections.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
30 Years
Study:
NCT06095492
Study Brief:
Protocol Section:
NCT06095492