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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
162
Take one tablet of the prescribed dose of the investigational drug by mouth, preferably with food and in the morning. Initial dose for the first 45 days of intervention.
take one tablet of the prescribed dose of the investigational drug by mouth, preferably with food and in the morning. Initial dose for the first 45 days of intervention.
Take one tablet of the prescribed dose of the investigational drug by mouth, preferably with food and in the morning. Escalation dose in cause the patient meets established criteria.
Centro de Investigación y Avances Médicos Especializados
Cancún, Quintana Roo, Mexico
Mérida Investigación Clínica
Mérida, Yucatán, Mexico
Centro de Investigación Médica Aguascalientes
Aguascalientes, Mexico
Oaxaca Site Management Organization SC.
Oaxaca City, Mexico
Compare changes in HbA1
Mean change in HbA1c
Time frame: baseline, 3 and 6 months of treatment
Proportion of patients who change their HbA1c concentration
Proportion of patients who change their HbA1c by at least 1 percent
Time frame: baseline, 3 and 6 months of treatment
Mean difference change between groups in HbA1c concentration
Difference greater than 0.3 between group A and B HbA1c concentration
Time frame: baseline, 3 and 6 months of treatment
Mean glucose change
Compare changes in glucose between baseline, 3 and 6 months of treatment
Time frame: baseline, 3 and 6 months of treatment
Incidence of adverse events and reactions
Description of al the adverse events and reactions presented during the study
Time frame: baseline, 3 and 6 months of treatment
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Take one tablet of the prescribed dose of the investigational drug by mouth, preferably with food and in the morning. Escalation dose in cause the patient meets established criteria.
Oncológico Potosino
San Luis Potosí City, Mexico