Oral Combination of Glimepiride/Vildagliptin/Metformin in Patients With T2D and Dual Treatment Failure

Prior treatment

• The drug is contraindicated for medical reasons.
• The patient is participating in another clinical study involving an investigational treatment or participated in one in the previous 4 weeks.

Other illness

• History of Type 1 Diabetes Mellitus.
• History of metabolic complications such as ketoacidosis or nonketotic hyperosmolar state.
• History of gastric bariatric surgery or gastric band in the last year.
• History of drug or alcohol abuse in the past year.
• At medical criteria, a disease that affects the prognosis and prevents outpatient management, for example, but not restricted to: end-stage cancer, kidney, heart, respiratory or liver failure, mental illness, with scheduled surgical or hospital procedures.

Lab values

• History of chronic liver disease or ALT and / or AST ≥3 times the normal upper limit and / or Total Bilirubin\> 2.5 times the upper limit of normal, or GGT ≥3 times the upper limit of normal.

Other

• Body Mass Index \<20 kg/m2 and \>40 kg/m2.
• Acute or severe renal dysfunction (glomerular filtration \<30 ml / min / 1.72 m2).
• Pregnant and / or lactating women.
• Be a patient with a working relationship with the main researcher or the research center or deprived of liberty.

• Male or Female.
• Age \>18 years old at the beginning of the study.
• Diagnosis of type 2 diabetes prior to the start of the study.
• Therapeutic failure to a dual treatment with SGLT2 / Metformin, Biguanide / Sulfonylurea, Sulfonylurea / iDPP4, Biguanide / iDPP4.
• HbA1c ≥ 7.5% and ≤ 11% during screening tests.
• Women of childbearing potential using a contraceptive method (barrier, oral hormonal, injectable, subdermal) or naturally or surgically sterile in menopause.
• Subject agree to participate in the study and give informed consent in writing.