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:
2025-12-26 @ 12:17 PM
Ignite Modification Date:
2025-12-26 @ 12:17 PM
NCT ID:
NCT04076800
Eligibility Criteria:
Inclusion Criteria:
* type 2 Diabetes Mellitus
* insulin therapy \> 20 UI daily for at least 6 months
* HbA1c \< 69 mmol/mol
Exclusion Criteria:
* Class I Psychiatric illness not adequately treated
* Actual pregnancy or breastfeeding, or pregnancy planning.
* Corticosteroid treatment
* Severe heart failure (NYHA III-IV)
* Severe renal failure (pre-dialysis o dialysis),
* Severe liver insufficiency (overt cirrhosis)
* Severe respiratory failure (oxygen therapy)
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
40 Years
Maximum Age:
70 Years
Study:
NCT04076800
Study Brief:
Protocol Section:
NCT04076800