| Trial ID: | L4095 |
| Source ID: | NCT04841096
|
| Associated Drug: |
A1=Glimepiride / Vildagliptin / Metformin (1 Mg/ 50 Mg/ 500 Mg)
|
| Title: |
Oral Combination of Glimepiride/Vildagliptin/Metformin in Patients With T2D and Dual Treatment Failure
|
| Acronym: |
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| Status: |
RECRUITING
|
| Study Results: |
NO
|
| Results: |
|
| 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/Metformin|DRUG: (B2) Glimepiride/Vildagliptin/Metformin
|
| Outcome Measures: |
Primary: Compare changes in HbA1, Mean change in HbA1c, 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, 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, baseline, 3 and 6 months of treatment | Secondary: Mean glucose change, Compare changes in glucose between baseline, 3 and 6 months of treatment, 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, baseline, 3 and 6 months of treatment
|
| Sponsor/Collaborators: |
Sponsor: Laboratorios Silanes S.A. de C.V.
|
| Gender: |
ALL
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| Age: |
ADULT, OLDER_ADULT
|
| Phases: |
PHASE3
|
| Enrollment: |
172
|
| Study Type: |
INTERVENTIONAL
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| Study Designs: |
Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: DOUBLE (PARTICIPANT, INVESTIGATOR)|Primary Purpose: TREATMENT
|
| Start Date: |
2023-03-21
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| Completion Date: |
2024-04
|
| Results First Posted: |
|
| Last Update Posted: |
2023-11-01
|
| Locations: |
Centro de Investigación y Avances Médicos Especializados, Cancún, Quintana Roo, 77506, Mexico|Mérida Investigación Clínica, Merida, Yucatan, 97125, Mexico|Centro de Investigación Médica Aguascalientes, Aguascalientes, 20116, Mexico|Oaxaca Site Management Organization SC., Oaxaca, 68000, Mexico|Oncológico Potosino, San Luis Potosí, 78250, Mexico
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| URL: |
https://clinicaltrials.gov/show/NCT04841096
|
