Status:
COMPLETED
Oral Combination of Glimepiride/Vildagliptin/Metformin in Patients With T2D and Dual Treatment Failure
Lead Sponsor:
Laboratorios Silanes S.A. de C.V.
Conditions:
Type 2 Diabetes
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief 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 ty...
Detailed Description
To achieve glycemic control goals, a combination of medications with complementary mechanisms of action, with fasting and postprandial effects, may be required to achieve and maintain clinically accep...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
March 21 2023
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 15 2024
Estimated Enrollment :
162 Patients enrolled
Trial Details
Trial ID
NCT04841096
Start Date
March 21 2023
End Date
May 15 2024
Last Update
June 10 2025
Active Locations (5)
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1
Centro de Investigación y Avances Médicos Especializados
Cancún, Quintana Roo, Mexico, 77506
2
Mérida Investigación Clínica
Mérida, Yucatán, Mexico, 97125
3
Centro de Investigación Médica Aguascalientes
Aguascalientes, Mexico, 20116
4
Oaxaca Site Management Organization SC.
Oaxaca City, Mexico, 68000