| Trial ID: | L3554 |
| Source ID: | NCT02954601
|
| Associated Drug: |
Ormd-0801 (Qd)
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| Title: |
A Study of Single and Multiple Doses of Oral Insulin or Placebo in Subjects With Type 2 Diabetes Mellitus
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| Acronym: |
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| Status: |
COMPLETED
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| Study Results: |
YES
|
| Results: |
https://ClinicalTrials.gov/show/NCT02954601/results
|
| Conditions: |
Type 2 Diabetes Mellitus
|
| Interventions: |
DRUG: ORMD-0801 (qd)|DRUG: ORMD-0801 (bid)|DRUG: ORMD-0801 (tid)|OTHER: Placebo
|
| Outcome Measures: |
Primary: Change in Glucose Levels Between Pre-treatment and End of Treatment as Measured by 24-hour Continuous Glucose Monitoring (CGM), Measure the change in Glucose (mg/dL) by 24 hour CGM between Day3 and Day8 (Change in mg/dL between run-in and Day 5 of Active treatment), Day 3 (run-in) and Day 8 (Day 5 of Active treatment) | Secondary: Calculate the C-peptide Ratio for Single and Multiple Doses of ORMD-0801 vs Placebo., For each dose, calculate the ratio of the C-Peptide measurement area-under-the-curve (ng-hr/mL) Day 8 to the C-peptide measurement area-under-the-curve (ng-hr/mL) Day 3. This ratio is called the C-peptide Ratio., Day 3 and Day 8|The Number Hypoglycemic Events for Single and Multiple Doses of ORMD-0801 vs Placebo, The number of safety parameter hypoglycemic events for single and multiple doses of ORMD-0801 vs placebo., Day 3 through Day 8 of treatment|Calculate the Difference Between Values of Pre-treatment and End-of-treatment Mean Daytime CGM Glucose, Calculate the difference between pre-treatment (Day 3) and end of treatment (Day 8) mean daytime CGM glucose for single and multiple doses of ORMD-0801 vs placebo., Day 3 and Day 8 (two timepoints)
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| Sponsor/Collaborators: |
Sponsor: Oramed, Ltd. | Collaborators: Integrium
|
| Gender: |
ALL
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| Age: |
ADULT, OLDER_ADULT
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| Phases: |
PHASE2
|
| Enrollment: |
31
|
| Study Type: |
INTERVENTIONAL
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| Study Designs: |
Allocation: RANDOMIZED|Intervention Model: CROSSOVER|Masking: QUADRUPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
|
| Start Date: |
2016-10
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| Completion Date: |
2017-03-15
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| Results First Posted: |
2018-07-12
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| Last Update Posted: |
2018-07-12
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| Locations: |
Orange County Research Center, Tustin, California, 92780, United States
|
| URL: |
https://clinicaltrials.gov/show/NCT02954601
|
