| Trial ID: | L7375 |
| Source ID: | NCT06560333
|
| Associated Drug: |
N0892
|
| Title: |
iSGLT2 Inhibitor and a iDPP -4 Inhibitor in Treatment of Type 2 Diabetes Mellitus in Patients Treated With Metformin (TRIAD)
|
| Acronym: |
TRIAD
|
| Status: |
NOT_YET_RECRUITING
|
| Study Results: |
NO
|
| Results: |
|
| Conditions: |
Diabetes Mellitus, Type 2
|
| Interventions: |
DRUG: N0892|DRUG: Januvia® + Glifage XR® + Placebo|DRUG: Forxiga® + Glifage XR® + Placebo
|
| Outcome Measures: |
Primary: Evaluate the glycemic control at week 16, Evaluate the superiority of the combined use of N0892 in glycemic control (reduction in HbA1c: Glycated haemoglobin) at week 16 in subjects receiving metformin, compared to Forxiga® and Januvia® alone, 16 weeks |
|
| Sponsor/Collaborators: |
Sponsor: Eurofarma Laboratorios S.A.
|
| Gender: |
ALL
|
| Age: |
ADULT, OLDER_ADULT
|
| Phases: |
PHASE3
|
| Enrollment: |
612
|
| Study Type: |
INTERVENTIONAL
|
| Study Designs: |
Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: QUADRUPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
|
| Start Date: |
2026-11-30
|
| Completion Date: |
2029-02-28
|
| Results First Posted: |
|
| Last Update Posted: |
2024-08-21
|
| Locations: |
Eurofarma Laboratorios S.A, São Paulo, SP, 06696-00, Brazil
|
| URL: |
https://clinicaltrials.gov/show/NCT06560333
|
