| Trial ID: | L6012 |
| Source ID: | NCT05760456
|
| Associated Drug: |
Didala Hard Capsules
|
| Title: |
Safety and Efficacy of DIDALA Monotherapy in Patients With Type 2 Diabetes Compared With Metformin.
|
| Acronym: |
|
| Status: |
UNKNOWN
|
| Study Results: |
NO
|
| Results: |
|
| Conditions: |
Type 2 Diabetes
|
| Interventions: |
DRUG: DIDALA hard capsules|DRUG: Metformin
|
| Outcome Measures: |
Primary: Change from Baseline at Week 12 in Hemoglobin A1c (HbA1c), Hemoglobin A1c, 12 weeks | Secondary: Change from Baseline at Week 12 in Fasting Plasma Glucose, Fasting Plasma Glucose, 12 weeks|Safety assessments, Safety will be assessed based on the frequency of occurrence of adverse events (AEs) of concern including hypoglycaemic events, clinically significant changes in laboratory parameters (complete blood count, blood biochemistry test), and vital signs during the study period., 12 weeks
|
| Sponsor/Collaborators: |
Sponsor: Centre of Clinical Pharmacology, Hanoi Medical University
|
| Gender: |
ALL
|
| Age: |
ADULT, OLDER_ADULT
|
| Phases: |
PHASE3
|
| Enrollment: |
140
|
| Study Type: |
INTERVENTIONAL
|
| Study Designs: |
Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT
|
| Start Date: |
2023-03-15
|
| Completion Date: |
2024-08-31
|
| Results First Posted: |
|
| Last Update Posted: |
2023-03-08
|
| Locations: |
Hanoi Hospital of Traditional Medical, Hanoi, Vietnam|National Hospital of Traditional Medicine, Hanoi, Vietnam
|
| URL: |
https://clinicaltrials.gov/show/NCT05760456
|
