Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
ORMD-0801- 2x · 1 trial · 1 indication
Tritiated glucose infusion during procedures (Baseline and every 30 minutes during procedures) Calculated from plasma(mg/kg-minute). Averaged every 30 minutes.
| Arm | Type | Description |
|---|---|---|
| ORAMED ORMD-0801 capsules- 2x8mg 1st; 3x8mg 2nd, 1x16mg 3rd | EXPERIMENTAL | Two 8 mg ORAMED capsules containing insulin then 3X8mg ORAMED capsules containing insulin, second study then 1X16mg ORAMED capsules containing insulin, third study |
| ORAMED ORMD-0801 capsules- 3x8mg 1st, 1x16mg 2nd, 2x8mg 3rd | EXPERIMENTAL | Three 8mg ORAMED capsules containing insulin then 1X16mg ORAMED capsules containing insulin, second study then 2X8mg ORAMED capsules containing insulin, third study |
| ORAMED ORMD-0801 capsules-1x16mg 1st, 2x8mg 2nd, 3x8mg 3rd | EXPERIMENTAL | One 16mg ORAMED capsule containing insulin then 2X8mg ORAMED capsule containing insulin, second study then 3X8mg ORAMED capsule containing insulin, third study |
| Name | Type | Description |
|---|---|---|
| ORMD-0801 capsules- 2x8mg | DRUG | Participants who receive this intervention first, then receive either ORMD-0801- 3x8mg or 1x16mg dose after a 3 day to 4 week interval. Participants receiving this drug as the second drug intervention will then receive the third intervention after a 3 day to 4 week interval. ORMD-0801 capsules are an oral insulin that has shown promise in preliminary studies. Investigators will evaluate this novel insulin preparation as a potential therapeutic option in diabetic patients. |
| ORMD-0801 capsules- 3x8mg | DRUG | Participants who receive this intervention first, then receive either ORMD-0801- 2x8mg or 1x16mg dose after a 3 day to 4 week interval. Participants receiving this drug as the second drug intervention will then receive the third intervention after a 3 day to 4 week interval. ORMD-0801 capsules are an oral insulin that has shown promise in preliminary studies. Investigators will evaluate this novel insulin preparation as a potential therapeutic option in diabetic patients. |
| ORMD-0801 capsules- 1x16mg | DRUG | Participants who receive this intervention first, then receive either ORMD-0801- 2x8mg or 3x8mg dose after a 3 day to 4 week interval. Participants receiving this drug as the second drug intervention will then receive the third intervention after a 3 day to 4 week interval. ORMD-0801 capsules are an oral insulin that has shown promise in preliminary studies. Investigators will evaluate this novel insulin preparation as a potential therapeutic option in diabetic patients. |
Inclusion Criteria: * Must be between 18 and 70 years of age * Must have type 1 diabetes * Must be in good general health by routine history and physical exam * A1c \<10.0% * BMI = 18-40 kg/m2 * On no medications known to affect glucose metabolism other than insulin * Hematocrit ≥ 34 vol% * Liver F...
ORMD-0801-2x is an investigational oral insulin being developed for the treatment of Type 1 Diabetes. It is a small molecule designed to manage blood glucose levels in patients with this condition. The drug is currently in Phase 2 clinical development and has not yet been approved by regulatory authorities.
ORMD-0801-2x is an oral insulin formulation that targets the insulin receptor to help regulate glucose metabolism in patients with Type 1 Diabetes. By delivering insulin orally, it aims to replace or supplement injected insulin, potentially improving glycemic control and patient convenience.
ORMD-0801-2x is being developed by Oramed Pharmaceuticals Inc., a biopharmaceutical company listed on the NASDAQ under the ticker symbol ORMP. The company is focused on developing oral formulations of proteins and peptides, with ORMD-0801-2x being one of its lead candidates for diabetes treatment.
ORMD-0801-2x is currently in Phase 2 clinical development. It has completed one Phase 2 trial, and the drug remains investigational, meaning it has not been approved by the FDA or other regulatory bodies. Further clinical studies are required to establish its safety and efficacy.
ORMD-0801-2x has one completed clinical trial registered under NCT02535715, titled "A Euglycemic Insulin Clamp Study in Type 1 Diabetic Patients With Oral Insulin (ORAMED)." This Phase 2 study enrolled 11 participants in the United States and evaluated the drug's effects in adults aged 18 years and older.
ORMD-0801-2x is an oral insulin formulation, but it is not the same as all oral insulins. It is a specific investigational product developed by Oramed Pharmaceuticals. While it shares the mechanism of delivering insulin orally, it is a distinct drug candidate with its own clinical development program.