Combination therapy for type 2 diabetes in patients with treatment failure
Efficacy and Safety of the Oral Combined Therapy Glimepiride / Vildagliptin / Metformin in Patients With Type 2 Diabetes With Dual Treatment Failure
This study is testing a new combination of diabetes medications to see if it can help people with type 2 diabetes who haven't been able to control their blood sugar with other treatments.
Quick facts
| Phase | Phase 3 |
|---|---|
| Study type | Interventional |
| Enrollment | 172 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Laboratorios Silanes S.A. de C.V. Industry-sponsored |
| Locations | 5 sites (Cancún, Quintana Roo and 4 other locations) |
| Trial ID | NCT04841096 on ClinicalTrials.gov |
What this trial studies
This phase IIIb clinical trial evaluates the efficacy and safety of a fixed-dose combination of glimepiride, vildagliptin, and metformin in patients with type 2 diabetes who have previously failed dual treatment. The study is randomized, multicenter, and double-blind, focusing on patients who have not achieved glycemic control with existing oral antidiabetic medications. Participants will be monitored for changes in HbA1c levels at 3 and 6 months to assess the effectiveness of the treatment. The goal is to improve compliance and reduce gastrointestinal side effects associated with multiple medications.
Who should consider this trial
Good fit: Ideal candidates are adults over 18 years old with type 2 diabetes who have experienced dual treatment failure and have HbA1c levels between 7.5% and 11%.
Not a fit: Patients with type 1 diabetes, severe renal dysfunction, or those who have had recent gastric bariatric surgery may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could help patients achieve better glycemic control and reduce the risk of long-term complications associated with type 2 diabetes.
How similar studies have performed: Other studies have shown success with similar combination therapies in managing type 2 diabetes, indicating a promising approach.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Cancún, Quintana Roo and 4 other locations
- Centro de Investigación y Avances Médicos Especializados — Cancún, Quintana Roo, Mexico (Not_yet_recruiting)
- Mérida Investigación Clínica — Merida, Yucatan, Mexico (Not_yet_recruiting)
- Centro de Investigación Médica Aguascalientes — Aguascalientes, Mexico (Recruiting)
- Oaxaca Site Management Organization SC. — Oaxaca, Mexico (Not_yet_recruiting)
- Oncológico Potosino — San Luis Potosí, Mexico (Not_yet_recruiting)
Study contacts
- Principal investigator: Salvador Pérez Jaime, M.D — Centro de Investigación Médica Aguascalientes (Red OSMO)
- Study coordinator: Jorge A González, PhD
- Email: jogonzalez@silanes.com.mx
- Phone: 5254883785
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.