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...
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ORMD-0801- 2x is an oral insulin product candidate developed by Oramed Pharmaceuticals Inc. (ticker ORMP) for the treatment of Type 1 Diabetes. It is a small molecule formulation being studied in clinical development. The 2x designation refers to a specific dose strength of the ORMD-0801 capsule program.
ORMD-0801- 2x is being developed for use in Type 1 Diabetes. It is an oral insulin candidate intended to provide insulin via the oral route. The completed Phase 2 trial enrolled adults with Type 1 Diabetes in the United States. It is investigational and has not been approved for commercial use.
ORMD-0801- 2x is made by Oramed Pharmaceuticals Inc., which trades under the ticker ORMP. Oramed is the developer of the ORMD-0801 oral insulin program, including the 2x8mg capsule strength referenced in the alternative name ORMD-0801 capsules- 2x8mg.
ORMD-0801- 2x is in Phase 2 clinical development. One Phase 2 trial has been completed, and no active trials are currently listed for this asset. It is an investigational product and has not been approved by the FDA or any regulatory authority.
ORMD-0801- 2x has been studied in one completed Phase 2 trial, NCT02535715, titled A Euglycemic Insulin Clamp Study in Type 1 Diabetic Patients With Oral Insulin (ORAMED). The trial enrolled 11 participants in the United States and included adults aged 18 years and older. It used a controlled design.