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 @ 6:40 PM
Ignite Modification Date:
2025-12-24 @ 6:40 PM
NCT ID:
NCT04392557
Eligibility Criteria:
Inclusion Criteria:
* DMT2 patients were enrolled in presence of
1. Age \>35 and \<75 years old
2. Uncontrolled diabetes during treatment (glycosylated hemoglobin (HbA1c) \> 75 mmol/mol )
3. Combined therapy at least by 6 months.
Exclusion Criteria:
1. HbA1c \< 75 mmol/mol (9%);
2. History of drug abuse or alcohol abuse, averaging more than 30 gm/day (3 drinks per day) in the previous 10 years, or history of alcohol intake averaging greater than 10 gm/day (1 drink per day: 7 drinks per week) in the previous one year;
3. Estimated glomerular filtration rate (GFR) \<30 ml/min (according to MDRD formula)
4. .Liver Failure
5. Recent history of Heart stroke, systemic infections, dehydration, lactic acidosis
6. Heart failure (NYHA I - IV)
7. Active bladder cancer or history of bladder cancer
8. macroscopic haematuria of unidentified nature
9. hypersensitivity to drug used (metformin, alogliptin, pioglitazone)
10. breastfeeding
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
35 Years
Maximum Age:
75 Years
Study:
NCT04392557
Study Brief:
Protocol Section:
NCT04392557