Oral Combination of Glimepiride/Vildagliptin/Metformin in Patients With T2D and Dual Treatment Failure
- Conditions
- Type 2 Diabetes
- Interventions
- Drug: A1=Glimepiride / Vildagliptin / Metformin (1 mg/ 50 mg/ 500 mg)Drug: B2=Glimepiride / Vildagliptin / Metformin (1 mg/ 50 mg/ 500 mg)Drug: (A2) Glimepiride/Vildagliptin/MetforminDrug: (B2) Glimepiride/Vildagliptin/Metformin
- Registration Number
- NCT04841096
- Lead Sponsor
- Laboratorios Silanes S.A. de C.V.
- 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 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.
- 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 acceptable glycemic control in some patients. A fixed combination of two or more therapeutic agents with complementary mechanisms of action makes it possible to optimize compliance and adherence to treatment among patients with T2D because it is administered once a day with the same efficacy of the separate components, but with fewer gastrointestinal effects. This is reflected in a reduction in HA1c and a lower evolution to long-term complications of T2D. 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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 172
- 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.
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Group A1: Glimepiride (1mg) / Vildagliptin (50mg) / Metformin (500mg). A1=Glimepiride / Vildagliptin / Metformin (1 mg/ 50 mg/ 500 mg) Tablets, orally, once a day. Initial dose for the first 45 days of intervention. Group B1: Glimepiride (1mg) / Vildagliptin (50mg) / Metformin (500mg) B2=Glimepiride / Vildagliptin / Metformin (1 mg/ 50 mg/ 500 mg) Tablets, orally, once a day. Initial dose for the first 45 days of intervention. Group A2: Glimepiride (2mg) / Vildagliptin (50mg) / Metformin (1000mg) (A2) Glimepiride/Vildagliptin/Metformin Tablets, orally, once a day. Dose escalation if the patients meets established criteria. Group B2: Glimepiride (4mg) / Vildagliptin (50mg) / Metformin (1000mg) (B2) Glimepiride/Vildagliptin/Metformin Tablets, orally, once a day. Dose escalation if the patients meets established criteria.
- Primary Outcome Measures
Name Time Method Compare changes in HbA1 baseline, 3 and 6 months of treatment Mean change in HbA1c
Proportion of patients who change their HbA1c concentration baseline, 3 and 6 months of treatment Proportion of patients who change their HbA1c by at least 1 percent
Mean difference change between groups in HbA1c concentration baseline, 3 and 6 months of treatment Difference greater than 0.3 between group A and B HbA1c concentration
- Secondary Outcome Measures
Name Time Method Incidence of adverse events and reactions baseline, 3 and 6 months of treatment Description of al the adverse events and reactions presented during the study
Mean glucose change baseline, 3 and 6 months of treatment Compare changes in glucose between baseline, 3 and 6 months of treatment
Trial Locations
- Locations (5)
Mérida Investigación Clínica
🇲🇽Merida, Yucatan, Mexico
Centro de Investigación Médica Aguascalientes
🇲🇽Aguascalientes, Mexico
Oaxaca Site Management Organization SC.
🇲🇽Oaxaca, Mexico
Oncológico Potosino
🇲🇽San Luis Potosí, Mexico
Centro de Investigación y Avances Médicos Especializados
🇲🇽Cancún, Quintana Roo, Mexico