Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Also known as insulin 338 (GIPET I)
insulin 338 · 5 trials · 4 indications
| Arm | Type | Description |
|---|---|---|
| Oral insulin 338 and subcutaneous placebo | EXPERIMENTAL | - |
| Subcutaneous insulin glargine and oral placebo | ACTIVE_COMPARATOR | - |
| Eating meal immediately after dosing | EXPERIMENTAL | - |
| Eating meal 30 min after dosing | EXPERIMENTAL | - |
| Eating meal 1 hour after dosing | EXPERIMENTAL | - |
| Eating meal 6 hour after dosing | EXPERIMENTAL | - |
| Part 1 insulin 338 | EXPERIMENTAL | - |
| Part 1 placebo | PLACEBO_COMPARATOR | - |
| Part 2 insulin 338 | EXPERIMENTAL | - |
| Part 2 insulin glargine | ACTIVE_COMPARATOR | - |
| Coating A | EXPERIMENTAL | Each subject will in random order be allocated to three single-dose administrations of insulin 338 in a GIPET® I tablet with 3 different coatings, respectively, on three separate dosing visits (Visits 2, 3 and 4). Each of the three dosing days will be separated by a 3-week wash-out period (ranging from 20 to 28 days) |
| Coating B | EXPERIMENTAL | Each subject will in random order be allocated to three single-dose administrations of insulin 338 in a GIPET® I tablet with 3 different coatings, respectively, on three separate dosing visits (Visits 2, 3 and 4). Each of the three dosing days will be separated by a 3-week wash-out period (ranging from 20 to 28 days) |
| Coating C | EXPERIMENTAL | Each subject will in random order be allocated to three single-dose administrations of insulin 338 in a GIPET® I tablet with 3 different coatings, respectively, on three separate dosing visits (Visits 2, 3 and 4). Each of the three dosing days will be separated by a 3-week wash-out period (ranging from 20 to 28 days) |
| Insulin 338 + placebo | EXPERIMENTAL | - |
| Insulin glargine + placebo | ACTIVE_COMPARATOR | - |
| Name | Type | Description |
|---|---|---|
| insulin 338 (GIPET I) | DRUG | Oral administered once daily in combination with metformin with or without DPP-4 inhibitor |
| insulin glargine | DRUG | Injected s.c./subcutaneously (under the skin) once daily in combination with metformin with or without DPP-4 inhibitor |
| placebo | DRUG | Administered once daily |
| Insulin 338 | DRUG | Healthy subjects will receive a single dose of insulin 338 in ascending doses. Injected subcutaneously (under the skin). |
Inclusion Criteria: * Age of 18-70 years (both inclusive) at the time of signing informed consent * Body mass index of 25.0-40.0 kg/m\^2 (both inclusive) * Subject diagnosed (clinically) with type 2 diabetes mellitus for at least 180 days prior to the day of screening * Insulin naïve subject; howev...
| Company | Ticker | Trials | Lead Phase | Drugs |
|---|---|---|---|---|
| FibroBiologics, Inc. | FBLG | 1 | PHASE1 | Undisclosed |
| MiMedx Group, Inc. | MDXG | 2 | N/A | Undisclosed |
| Integra LifeSciences Holdings Corporation | IART | 1 | N/A | Undisclosed |
| Organogenesis Holdings, Inc. Class A | ORGO | 1 | N/A | Undisclosed |
| Healthcare Services Group, Inc. | HCSG | 1 | N/A | Undisclosed |