| Trial ID: | L6378 |
| Source ID: | NCT05886088
|
| Associated Drug: |
Lid104
|
| Title: |
Efficacy and Safety of LID104 in the Treatment of Type II Diabetes Mellitus
|
| Acronym: |
DÁLIA
|
| Status: |
NOT_YET_RECRUITING
|
| Study Results: |
NO
|
| Results: |
|
| Conditions: |
Type 2 Diabetes Mellitus
|
| Interventions: |
DRUG: LID104|DRUG: Dapagliflozin|DRUG: Linagliptin
|
| Outcome Measures: |
Primary: Glycated hemoglobin (HbA1c), Change from baseline in glycated hemoglobin, 120 days | Secondary: Fasting blood glucose, Change from baseline in fasting blood glucose, 120 days|HbA1c reduction to < 7%, Proportion of participants with HbA1c reduction to \< 7%, 120 days|Treatment failure, Proportion of participants who were discontinued from the study because they needed medication other than the study medication for blood glucose control, Up to 140 days|Body weight, Change from baseline in body weight, Up to 140 days|Blood pressure, Change from baseline in blood pressure, Up to 140 days
|
| Sponsor/Collaborators: |
Sponsor: EMS
|
| Gender: |
ALL
|
| Age: |
ADULT, OLDER_ADULT
|
| Phases: |
PHASE3
|
| Enrollment: |
597
|
| Study Type: |
INTERVENTIONAL
|
| Study Designs: |
Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: QUADRUPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
|
| Start Date: |
2024-02
|
| Completion Date: |
2027-01
|
| Results First Posted: |
|
| Last Update Posted: |
2023-06-02
|
| Locations: |
Investigational site, Hortolândia, SP, Brazil
|
| URL: |
https://clinicaltrials.gov/show/NCT05886088
|
