| Trial ID: | L4169 |
| Source ID: | NCT04754334
|
| Associated Drug: |
Ormd-0801
|
| Title: |
A Phase 3 Study to Evaluate the Efficacy and Safety of ORMD-0801 in Subjects With Type 2 Diabetes Mellitus
|
| Acronym: |
|
| Status: |
TERMINATED
|
| Study Results: |
NO
|
| Results: |
|
| Conditions: |
T2DM (Type 2 Diabetes Mellitus)
|
| Interventions: |
DRUG: ORMD-0801|OTHER: Placebo
|
| Outcome Measures: |
Primary: Mean change in A1C, mean change from baseline (Visit 1) in A1C at 26 weeks (Visit 6) for the active and placebo groups. Randomization will occur at Visit 1 (Week 0),, Baseline and Week 26 | Secondary: The mean change in fasting plasma glucose, The mean change from baseline (Visit 1) in fasting plasma glucose at 26 weeks (Visit 6), baseline and week 26
|
| Sponsor/Collaborators: |
Sponsor: Oramed, Ltd. | Collaborators: Integrium
|
| Gender: |
ALL
|
| Age: |
ADULT, OLDER_ADULT
|
| Phases: |
PHASE3
|
| Enrollment: |
346
|
| Study Type: |
INTERVENTIONAL
|
| Study Designs: |
Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: QUADRUPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
|
| Start Date: |
2021-03-16
|
| Completion Date: |
2023-01-13
|
| Results First Posted: |
|
| Last Update Posted: |
2023-02-09
|
| Locations: |
Research Institute of South Florida, Inc. (PHARMASEEK), Coral Gables, Florida, 33124, United States
|
| URL: |
https://clinicaltrials.gov/show/NCT04754334
|
