Type 2 Diabetes
Conditions
Keywords
Type 2 diabetes, Combine therapy, Hypoglycemic agents
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.
Interventions
DRUGA1=Glimepiride / Vildagliptin / Metformin (1 mg/ 50 mg/ 500 mg)
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.
DRUGB2=Glimepiride / Vildagliptin / Metformin (1 mg/ 50 mg/ 500 mg)
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.
DRUG(A2) Glimepiride/Vildagliptin/Metformin
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.
DRUG(B2) Glimepiride/Vildagliptin/Metformin
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.
Sponsors
Laboratorios Silanes S.A. de C.V.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| Mean glucose change | baseline, 3 and 6 months of treatment | Compare changes in glucose between baseline, 3 and 6 months of treatment |
| 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 |
Countries
Mexico
Outcome results
None listed