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

• Status: Not yet recruiting
• Trial end date: 2022-03-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Laboratorios Silanes S.A. de C.V.
• Treatments: Glimepiride; Metformin; Vildagliptin

Criteria

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.