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 @ 3:41 PM
Ignite Modification Date:
2025-12-24 @ 3:41 PM
NCT ID:
NCT04943692
Eligibility Criteria:
Inclusion Criteria:
* Subjects ≥18 years old.
* Type 2 diabetes according to ADA diagnostic criteria.
* Naive to treatment or who have previously been under oral hypoglycemic treatment (whatever it may be), as long as it has been suspended for a period of ≥6 weeks prior to the start of the study. - HbA1c ≥7.5% and \<10.0%.
* In the case of women of childbearing age and with an active sexual life, the use of birth control methods is required; any of the following are accepted: barrier (male or female condom), non-hormonal intrauterine device, or bilateral tubal obstruction.
* That you agree to participate in the study and give written informed consent.
Exclusion Criteria:
* Patients with known current abuse or dependence (last 2 months) to substances such as alcohol (weekly consumption\> 21 units of alcohol in men or\> 14 units of alcohol in women) or recreational drugs.
* Body Mass Index \<20 kg / m2 and\> 35 kg / m2.
* Glomerular filtration estimated with the MDRD (Modification of Diet in Renal Disease) procedure through serum creatinine \<60 ml / min / 1.72 m2.
* History of chronic liver disease or ALT (alanine aminotransferase) and / or AST (aspartate aminotransferase) ≥ 2 times the upper limit of normal, or GGT (Gamma glutamyl transpeptidase) ≥3 times the upper limit of normal.
* Chronic lung disease, causing dyspnea equivalent to a functional class ≥3 (NYHA) or requiring oxygen supplementation.
* Use of drugs that interact with biguanides.
* Other chronic diseases that limit survival or are associated with chronic inflammation such as: cancer, leukemia, lymphoma, lupus erythematosus, asthma, rheumatoid arthritis, or HIV (human immunodeficiency virus) infection.
* Pregnancy or positive pregnancy test, as well as women who are breastfeeding.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT04943692
Study Brief:
Protocol Section:
NCT04943692