Clinical trial NCT04841096: Oral Combination of Glimepiride/Vildagliptin/Metformin in Patients With T2D and Dual Treatment Failure
Official title: Efficacy and Safety of the Oral Combined Therapy Glimepiride / Vildagliptin / Metformin in Patients With Type 2 Diabetes With Dual Treatment Failure
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Type 2 Diabetes
Keywords: Type 2 diabetes
Combine therapy
Hypoglycemic agents
Lead sponsor: Laboratorios Silanes S.A. de C.V.
Sponsor class: INDUSTRY
First posted: 2021-04-12
Enrollment: 162
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility 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.

Primary outcomes:
measure: Compare changes in HbA1
timeFrame: baseline, 3 and 6 months of treatment
measure: Proportion of patients who change their HbA1c concentration
timeFrame: baseline, 3 and 6 months of treatment
measure: Mean difference change between groups in HbA1c concentration
timeFrame: baseline, 3 and 6 months of treatment
Secondary outcomes:
measure: Mean glucose change
timeFrame: baseline, 3 and 6 months of treatment
measure: Incidence of adverse events and reactions
timeFrame: baseline, 3 and 6 months of treatment
Other outcomes:
Locations:
city: Cancún
country: Mexico
facility: Centro de Investigación y Avances Médicos Especializados
state: Quintana Roo
city: Merida
country: Mexico
facility: Mérida Investigación Clínica
state: Yucatan
city: Aguascalientes
country: Mexico
facility: Centro de Investigación Médica Aguascalientes
city: Oaxaca
country: Mexico
facility: Oaxaca Site Management Organization SC.
city: San Luis Potosí
country: Mexico
facility: Oncológico Potosino
Study officials:
affiliation: Centro de Investigación Médica Aguascalientes (Red OSMO)
name: Salvador Pérez Jaime, M.D
role: PRINCIPAL_INVESTIGATOR
affiliation: Centro de Investigación y Avances Médicos Especializados (Red OSMO)
name: Juan A Becerra Hernández, M.D
role: PRINCIPAL_INVESTIGATOR
affiliation: Oaxaca Site Management Organization SC. (Red OSMOS)
name: Ana L Flores Barranco, M.D
role: PRINCIPAL_INVESTIGATOR
affiliation: Oncológico Potosino (Red OSMO)
name: Abraham S Álvarez, M.D
role: PRINCIPAL_INVESTIGATOR
affiliation: Mérida Investigación Clínica (Red OSMO)
name: Victor C Bohórquez López, M.D
role: PRINCIPAL_INVESTIGATOR
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