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 @ 2:49 AM
Ignite Modification Date:
2025-12-25 @ 2:49 AM
NCT ID:
NCT02846233
Eligibility Criteria:
Inclusion Criteria:
The following patients with diabetes mellitus type 2 who can give written consent will be eligible for enrollment. They must meet all criteria.
1. \> 21 years of age
2. Body mass index (BMI) ≥30 kg/m2
3. On insulin at least 2 times daily comprising both a basal and a prandial insulin or a pre-mix insulin with or without other non-insulin medications for a least past 3 months
4. A1c \>8%
5. eGFR \>45%
Exclusion Criteria:
The patients with any of the following criteria will be excluded.
1. Any patient who does not meet the above inclusion criteria.
2. Pregnancy
3. Patients who are on a SGLT2i and a GLP1 RA injection at the time of enrollment.
4. diabetes mellitus type 1
5. C-peptide below normal range if measured in the past.
6. patients with a history of diabetes ketoacidosis
7. A history of recent and frequent (≥ 2 times within past 3 months) urinary tract infection or genito-urinary candidiasis requiring antibiotic and/or anti-fungal therapies.
8. a personal or family history of medullary thyroid carcinoma (MTC) or in patients with Multiple Endocrine Neoplasia syndrome type 2 (MEN 2)
9. eGFR \<45%
10. patients with a history of acute pancreatitis
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
21 Years
Study:
NCT02846233
Study Brief:
Protocol Section:
NCT02846233