Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
ORMD-0801 · 6 trials · 5 indications
Change from baseline (Visit 1) in A1C at 26 weeks (Visit 6).
| Arm | Type | Description |
|---|---|---|
| ORMD-0801 8 mg once-daily at night - QD | ACTIVE_COMPARATOR | Double-Dummy; the subject receives both experimental drug and placebo. 1 x 8 mg capsule between 8 PM to 12 Midnight and no sooner than 1 hour after dinner and 2 placebo capsules (1 in the morning and 1 at night). |
| ORMD-0801 8 mg twice daily - BID | ACTIVE_COMPARATOR | Double-Dummy; the subject receives both experimental drug and placebo. 1 x 8 mg capsule each morning approximately 45 minutes (±15 minutes) prior to breakfast and 1 x 8 mg capsule each night prior to bedtime (between 8 PM to 12 Midnight and no sooner than 1 hour after dinner) and 1 placebo capsule at night. |
| ORMD-0801 16 mg once-daily at night - QD | ACTIVE_COMPARATOR | Double-Dummy; the subject receives both experimental drug and placebo. 2 x 8 mg capsules between 8 PM to 12 Midnight and no sooner than 1 hour after dinner and 1 placebo capsule in the morning. |
| Placebo | PLACEBO_COMPARATOR | The subject receives 3 placebo capsules. |
| Name | Type | Description |
|---|---|---|
| ORMD-0801 8 mg | DRUG | 1 x 8 mg capsule between 8 PM to 12 Midnight and no sooner than 1 hour after dinner and 2 placebo capsules (1 in the morning and 1 at night). |
| Placebo capsule | OTHER | Placebo capsule |
| ORMD-0801 16 mg | DRUG | 2 x 8 mg capsules between 8 PM to 12 Midnight and no sooner than 1 hour after dinner and 1 placebo capsule in the morning. |
| ORMD-0801 QD | DRUG | 16 mg, QD, two capsules, 8 mg each. |
| ORMD-0801 | DRUG | 8 mg capsules of ORMD-0801 (Oral Insulin) |
| Placebo | OTHER | Placebo capsule (Fish Oil) |
| ORMD-0801 (qd) | DRUG | Dose 1 = ORMD-0801 (qd) |
| ORMD-0801 (bid) | DRUG | Dose 2 = ORMD-0801 (bid) |
| ORMD-0801 (tid) | DRUG | Dose 3 = ORMD-0801 (tid) |
| Placebo Comparator | DRUG | Placebo |
| ORMD-0801 Capsules | BIOLOGICAL | API (recombinant human insulin USP), in Oramed's proprietary formulation in capsules. |
Inclusion Criteria: * Male and female subjects aged ≥ 50 years. * Established diagnosis of T2DM for at least 6 months prior to Screening AND an A1C ≥ 7.2% but ≤ 10.0% at Screening. * On a stable dose of at least one and up to three of the following glucose-lowering agents: Metformin, sulfonylurea, ...