| Trial ID: | L1795 |
| Source ID: | NCT04670666
|
| Associated Drug: |
Madalena Association
|
| Title: |
Efficacy and Safety of Madalena Association in the Treatment of Type II Diabetes Mellitus
|
| Acronym: |
|
| Status: |
NOT_YET_RECRUITING
|
| Study Results: |
NO
|
| Results: |
|
| Conditions: |
Type 2 Diabetes Mellitus
|
| Interventions: |
DRUG: MADALENA ASSOCIATION|DRUG: METFORMIN|DRUG: EMPAGLIFLOZIN + LINAGLIPTIN|OTHER: MADALENA ASSOCIATION PLACEBO|OTHER: METFORMIN PLACEBO|OTHER: EMPAGLIFLOZIN + LINAGLIPTIN PLACEBO
|
| Outcome Measures: |
Primary: Change from baseline in glycated hemoglobin (HbA1c) levels., 120 days | Secondary: Incidence and severity of adverse events recorded during the study., 150 days
|
| Sponsor/Collaborators: |
Sponsor: EMS
|
| Gender: |
ALL
|
| Age: |
ADULT, OLDER_ADULT
|
| Phases: |
PHASE3
|
| Enrollment: |
270
|
| Study Type: |
INTERVENTIONAL
|
| Study Designs: |
Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: DOUBLE (PARTICIPANT, INVESTIGATOR)|Primary Purpose: TREATMENT
|
| Start Date: |
2024-05
|
| Completion Date: |
2025-06
|
| Results First Posted: |
|
| Last Update Posted: |
2024-02-16
|
| Locations: |
|
| URL: |
https://clinicaltrials.gov/show/NCT04670666
|
