Clinical Trial Details
| Trial ID: | L5633 |
| Source ID: | NCT02496000 |
| Associated Drug: | Ormd-0801 |
| Title: | Phase II Safety and Efficacy Study of Oral ORMD-0801 in Patients With Type 2 Diabetes Mellitus |
| Acronym: | |
| Status: | COMPLETED |
| Study Results: | YES |
| Results: | https://ClinicalTrials.gov/show/NCT02496000/results |
| Conditions: | Diabetes Type 2 |
| Interventions: | DRUG: ORMD-0801|DRUG: Placebo Comparator |
| Outcome Measures: | Primary: Measure of the Mean Night Time Glucose Levels Based on Two Nights of Glucose Measurements., The Effect of ORMD-0801 (Doses 1 \& 2, Pooled) on Mean Night Time Glucose Levels (measured in mg/dL) Based on 2 Nights of Continuous Glucose Monitor (CGM) Data by Comparison of the Mean Change Between Baseline and Wk 4 of ORMD-0801 Treatment and Placebo Groups. The primary analysis will be based on the results from the two last days, unless technical difficulties preclude calculation of the weighted mean glucose levels. In this case, the last two days (selected between days 5, 6, and 7) with at least 80% of the expected number of measurements will be used. If days 5, 6 and 7 do not have 2 days with at least 80% of the expected number of measurements for a specific subject, then the value will be missing for that subject., Baseline-Study day -7 (± 1 day) through Study day 1 (± 1 day), and Week 4 -Study day 22 (± 1 day) through Study day 29 (± 1 day) | Secondary: The Effect of ORMD-0801 on Mean 24-hour Glucose, The effect of ORMD-0801 (Dose 1 and Dose 2 individually) on mean 24-hour glucose based on 2 nights of CGM data by comparison of the mean percent change between baseline and Wk 4 of ORMD-0801 treatment and the placebo groups., Study day -7 (± 1 day) through Study day 1 (± 1 day), and Study day 22 (±1 day) - Study day 29 (± 1 day)|Measure Percent Change in Continuous Glucose Monitoring Mean Fasting Glucose Between Treatment and Run-In, The percent change in the Continuous Glucose Monitoring Mean Fasting Glucose between treatment and mean of the last two days of the baseline(run-in period)., Baseline (Run-in days 13-14) and Study day 1 (± 1 day) through Study day 29 (± 1 day)|Measure the Change From Baseline to End of the Study of Morning Fasting C-Peptide (Nmol/L), The measurement of the change in Morning Fasting C-peptide between baseline to end of the study, measured in Nmol/L, Study day 1 (±1 day) through Study day43 (± 1 day)|The Effect of ORMD-0801 on the Percent Change in HbA1c, The effect of ORMD-0801 (Dose 1 and Dose 2 individually) on the percent change from baseline to Wk 4 in HbA1c, Study day 1 (± 1 day) through Study day 29 (± 1 day) |
| Sponsor/Collaborators: | Sponsor: Oramed, Ltd. | Collaborators: Integrium |
| Gender: | ALL |
| Age: | ADULT, OLDER_ADULT |
| Phases: | PHASE2 |
| Enrollment: | 188 |
| Study Type: | INTERVENTIONAL |
| Study Designs: | Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: QUADRUPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT |
| Start Date: | 2015-07-27 |
| Completion Date: | 2016-09-13 |
| Results First Posted: | 2017-02-17 |
| Last Update Posted: | 2019-11-13 |
| Locations: | Steingard Medical Group, Phoenix, Arizona, 85015, United States|Arkansas Primary Care Clinic, PA, Little Rock, Arkansas, 72204, United States|Dream Team Clinical Research, Anaheim, California, 92801, United States|ACTCA, Inc., Los Angeles, California, 90017, United States|ACTCA, Los Angeles, California, 90036, United States|National Research Institute, Los Angeles, California, 90057, United States|Providence Clinical Research, North Hollywood, California, 91606, United States|Mills-Peninsula Health Services, San Mateo, California, 94401, United States|Orange County Research Center, Tustin, California, 92780, United States|Creekside Endocrine Associates, PC, Denver, Colorado, 80209, United States|Meridien Research, Bradenton, Florida, 34208, United States|Meridien Research, Brooksville, Florida, 34601, United States|Clinical Research of West Florida, Inc., Clearwater, Florida, 33765, United States|Research in Miami Inc., Hialeah, Florida, 33013, United States|Research in Miami, Inc., Hialeah, Florida, 33013, United States|Phoenix Medical Research LLC, Miami, Florida, 33165, United States|Ormond Medical Arts Pharmaceutical Research Center, Ormond Beach, Florida, 32174, United States|Clinical Research of West Florida, Inc., Tampa, Florida, 33603, United States|Meridien Research, Tampa, Florida, 33634, United States|Metabolic Research Institute, Inc, West Palm Beach, Florida, 33401, United States|Heartland Research Associates, LLC, Wichita, Kansas, 67207, United States|Maine Research Associates, Auburn, Maine, 04210, United States|Apex Medical Research, MI, Inc, Flint, Michigan, 48504, United States|Impact Clinical Trials, Las Vegas, Nevada, 89106, United States|New York Clinical Trials, New York, New York, 10018, United States|Lynn Institute of Norman, Norman, Oklahoma, 73069, United States|Upstate Pharmaceutical Research, Greenville, South Carolina, 29615, United States|Padre Coast Clinical Research, Corpus Christi, Texas, 78404, United States|Sun Research Institute, San Antonio, Texas, 78215, United States|Southwest Clinic, San Antonio, Texas, 78221, United States|Panacea Clinical Research, San Antonio, Texas, 78228, United States|Clinical Trials of Texas, Inc., San Antonio, Texas, 78229, United States|Wasatch Clinical Research, LLC, Salt Lake City, Utah, 84107, United States|Rainier Clinical Research Center, Inc., Renton, Washington, 98057, United States |
| URL: | https://clinicaltrials.gov/show/NCT02496000 |
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