| Trial ID: | L5596 |
| Source ID: | NCT03467932
|
| Associated Drug: |
Cohort A: Ormd-0801
|
| Title: |
A Study to Evaluate the Efficacy and Safety of ORMD-0801 (Oral Insulin) in Patients With Type 2 Diabetes Mellitus
|
| Acronym: |
|
| Status: |
COMPLETED
|
| Study Results: |
YES
|
| Results: |
https://ClinicalTrials.gov/show/NCT03467932/results
|
| Conditions: |
T2DM (Type 2 Diabetes Mellitus)
|
| Interventions: |
DRUG: Cohort A: ORMD-0801|DRUG: Placebo oral capsule|DRUG: Cohort B: ORMD-0801
|
| Outcome Measures: |
Primary: Change From Baseline of HbA1C (Glycated Hemoglobin), Least Squares Means change in HbA1C from baseline to Week 12 of the treatment period, where HbA1C is reported in units of percent. The change in HbA1c from baseline to Week 12 is expressed as a change in the value of HbA1C., baseline (Run-in period, Week 0, Visit 1) and Week 12 (follow-up) | Secondary: Mean Change From Baseline Over Time for HbA1C, Mean change from baseline (Run-In, Week 0 Visit 1) to Part 1, Visit 3 for HbA1C (measured in mmols/mol), Baseline (Run-In:Week 0, Visit 1) to Part 1, Visit 3, elapsed time: 3 weeks.|Change Over Time in Hb1Ac, Change of Hb1Ac from Baseline to Week 10, measured in mmol/mol, Baseline (week 0, visit 1) to Week 10, part 2
|
| Sponsor/Collaborators: |
Sponsor: Oramed, Ltd. | Collaborators: Integrium
|
| Gender: |
ALL
|
| Age: |
ADULT, OLDER_ADULT
|
| Phases: |
PHASE2
|
| Enrollment: |
373
|
| Study Type: |
INTERVENTIONAL
|
| Study Designs: |
Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: QUADRUPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
|
| Start Date: |
2018-05-29
|
| Completion Date: |
2020-02-18
|
| Results First Posted: |
2022-11-08
|
| Last Update Posted: |
2022-11-08
|
| Locations: |
AA MRC, Flint, Michigan, 48504, United States
|
| URL: |
https://clinicaltrials.gov/show/NCT03467932
|
