11 completed, 2 terminated, 1 not yet recruiting, 1 unknown. 11 Phase 2, 4 Phase 3.
| Phase | Trials | Status |
|---|---|---|
| Phase 2 | 11 | Completed 11 |
| Phase 3 | 4 | Terminated 2, Not yet recruiting 1, Unknown 1 |
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Tick up to 5 trials to compare them side by side (eligibility, arms, endpoints, adverse events) in a Literature Matrix.
| Trial | Phase | Status | Sponsor | Enrollment | Start | Updated |
|---|---|---|---|---|---|---|
| A Phase 3 Study to Evaluate the Efficacy and Safety of ORMD-0801 in Subjects With Type 2 Diabetes Mellitus. ORMD-0801 8 mg, Placebo capsule, ORMD-0801 16 mg - Type 2 Diabetes Mellitus | Phase 3 | Not yet recruiting | Oramed, Ltd. | 300 | 2025-12-15 | 2025-08-03 |
| Phase 3 Study to Evaluate the Efficacy and Safety of ORMD-0801 in Subjects With Type 2 Diabetes Mellitus ORMD-0801 - Diabetes Mellitus, Type 2 | Phase 3 | Unknown | King Hamad University Hospital, Bahrain | 608 | 2021-10-01 | 2021-03-26 |
| A Phase 3 Study to Evaluate the Efficacy and Safety of ORMD-0801 in Subjects With Type 2 Diabetes Mellitus ORMD-0801, Placebo - T2DM (Type 2 Diabetes Mellitus) | Phase 3 | Terminated | Oramed, Ltd. | 346 | 2021-03-16 | 2023-02-09 |
| A Study of Oral Insulin to Reduce Liver Fat Content in Type 2 Diabetes Patients With Nonalcoholic Steatohepatitis (NASH) ORMD-0801 QD - Nonalcoholic Steatohepatitis (NASH) | Phase 2 | Completed | Oramed, Ltd. | 7 | 2021-03-01 | 2024-03-29 |
| Study to Evaluate the Efficacy and Safety of ORMD-0801 in Subjects With Type 2 Diabetes Mellitus Placebo, ORMD-0801 QD, ORMD-0801 BD - Type 2 Diabetes Mellitus | Phase 3 | Terminated | Oramed, Ltd. | 710 | 2020-12-15 | 2023-02-09 |
| A Study to Assess the Safety and Efficacy of Oral Insulin in T2DM Patients With Nonalcoholic Steatohepatitis (NASH) ORMD-0801 (Insulin) capsule 8 mg BD, Placebo - Diabetes Mellitus, Type 2, NASH - Nonalcoholic Steatohepatitis | Phase 2 | Completed | Oramed, Ltd. | 32 | 2020-11-24 | 2024-08-07 |
| A Study to Evaluate the Effect of ORMD-0801 in Patients With Type 2 Diabetes Mellitus ORMD-0801, Placebo - Diabetes Mellitus, Type 2 | Phase 2 | Completed | Oramed, Ltd. | 49 | 2020-11-23 | 2024-05-07 |
| A Study to Compare ORMD-0801 Once Daily to ORMD-0801 Three Times Daily in Subjects With Type 1 Diabetes ORMD-0801 Treatment A, ORMD-0801 Treatment B, Placebo - Type 1 Diabetes | Phase 2 | Completed | Oramed, Ltd. | 30 | 2019-10-17 | 2022-06-02 |
| A Pilot Study to Assess the Safety of Oral Insulin in Patients With Nonalcolholic Steatohepatitis (NASH) Oral Insulin - Non-Alcoholic Steatohepatitis (NASH), Type2 Diabetes Mellitus | Phase 2 | Completed | Oramed, Ltd. | 10 | 2018-09-20 | 2024-03-13 |
| A Study to Evaluate the Efficacy and Safety of ORMD-0801 (Oral Insulin) in Patients With Type 2 Diabetes Mellitus Cohort A: ORMD-0801, Placebo oral capsule, Cohort B: ORMD-0801 - T2DM (Type 2 Diabetes Mellitus) | Phase 2 | Completed | Oramed, Ltd. | 373 | 2018-05-29 | 2022-11-08 |
| A Study of Single and Multiple Doses of Oral Insulin or Placebo in Subjects With Type 2 Diabetes Mellitus ORMD-0801 (qd), ORMD-0801 (bid), ORMD-0801 (tid) - Type 2 Diabetes Mellitus | Phase 2 | Completed | Oramed, Ltd. | 31 | 2016-10-01 | 2018-07-12 |
| Phase II Safety and Efficacy Study of Oral ORMD-0801 in Patients With Type 2 Diabetes Mellitus ORMD-0801, Placebo Comparator - Diabetes Type 2 | Phase 2 | Completed | Oramed, Ltd. | 188 | 2015-07-27 | 2019-11-13 |
| A Euglycemic Insulin Clamp Study in Type 1 Diabetic Patients With Oral Insulin (ORAMED) ORMD-0801 capsules- 2x8mg, ORMD-0801 capsules- 3x8mg, ORMD-0801 capsules- 1x16mg - Type 1 Diabetes | Phase 2 | Completed | The University of Texas Health Science Center at San Antonio | 11 | 2015-01-01 | 2019-03-21 |
| A Prospective, Randomized, Double-blind, Placebo Controlled Study to Assess the Impact of ORMD-0801 (Insulin Capsules) on the Exogenous Insulin Requirements of Type 1 Diabetics ORMD-0801 Capsules, Placebo - Diabetes Mellitus Type 1 | Phase 2 | Completed | Oramed, Ltd. | 25 | 2014-03-01 | 2017-07-06 |
| Safety, Pharmacokinetics (PK) and Pharmacodynamics (PD) of Multiple Oral Bedtime Doses of ORMD-0801 in Adult Patients With Type 2 Diabetes Mellitus (T2DM) ORMD-0801 Dose # 1, ORMD-0801 Dose # 2, Placebo - Diabetes Mellitus Type 2 | Phase 2 | Completed | Oramed, Ltd. | 30 | 2013-06-01 | 2015-04-16 |
Diabetes Mellitus, Type 2 (10) · Diabetes Mellitus, Type 1 (3) · Non-alcoholic Fatty Liver Disease (3)
Insulin (14) · ORMD-0801 (8) · Fish Oils (7) · BID protein, human (1) · Capsules (1) · Edetic Acid (1) · Polysorbates (1) · Silicon Dioxide (1)
United States (12) · Israel (2) · Belgium (1)
Joel M Neutel, M. D. (5) · Miriam Kidron, PhD (4) · Miriam Kidron, Ph.D. (3) · Dr. Dalal Alromaihi (1) · Ele Ferrannini, M. D. (1) · Joel M Neutel, M.D. (1) · Ralph A DeFronzo, MD (1) · Rifaat Safadi, M.D. (1)