Efficacy and Safety of the Oral Combined Therapy Glimepiride / Vildagliptin / Metformin in Patients With Type 2 Diabetes With Dual Treatment Failure

SIL-30013-III-20(1)

Phase IIIb, randomized, multicenter, double-blind, prospective study to evaluate the efficacy and safety of a daily fixed-dose combination of glimepiride / vildagliptin / metformin in patients with type 2 diabetes with a history of dual treatment failure and combined or individual oral antidiabetics with SGLT2 / Metformin, Biguanide / Sulfonylurea, Sulfonylurea / iDPP4 or Biguanide / iDPP4. To evaluate the changes in the percentage of HbA1c at 3 and 6 months with regard to their baseline measurement.

2023-03-21

2024-03-01

2024-04-01

Recruiting

Early phase I

172

Inclusion Criteria: * 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. Exclusion Criteria: * The drug is contraindicated for medical reasons. * 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. * Body Mass Index \<20 kg/m2 and \>40 kg/m2. * Acute or severe renal dysfunction (glomerular filtration \<30 ml / min / 1.72 m2). * 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. * Pregnant and / or lactating women. * The patient is participating in another clinical study involving an investigational treatment or participated in one in the previous 4 weeks. * 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. * Be a patient with a working relationship with the main researcher or the research center or deprived of liberty.

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE3'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}}, 'enrollmentInfo': {'count': 172, 'type': 'ESTIMATED'}}

2023-11-01