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Oral Combination of Glimepiride/Vildagliptin/Metformin in Patients With T2D and Dual Treatment Failure

NCT04841096 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 162

Last updated 2025-06-10

No results posted yet for this study

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.

Conditions

Interventions

DRUG

A1=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

B2=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 & Collaborators

  • Laboratorios Silanes S.A. de C.V.

    lead INDUSTRY

Principal Investigators

  • Salvador Pérez Jaime, M.D · Centro de Investigación Médica Aguascalientes (Red OSMO)

  • Juan A Becerra Hernández, M.D · Centro de Investigación y Avances Médicos Especializados (Red OSMO)

  • Ana L Flores Barranco, M.D · Oaxaca Site Management Organization SC. (Red OSMOS)

  • Abraham S Álvarez, M.D · Oncológico Potosino (Red OSMO)

  • Victor C Bohórquez López, M.D · Mérida Investigación Clínica (Red OSMO)

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2023-03-21
Primary Completion
2024-03-15
Completion
2024-05-15

Countries

  • Mexico

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04841096 on ClinicalTrials.gov