Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
EX1000 · 2 trials · 2 indications
| Arm | Type | Description |
|---|---|---|
| A | EXPERIMENTAL | - |
| B | ACTIVE_COMPARATOR | - |
| Name | Type | Description |
|---|---|---|
| EX1000 | DRUG | Treat-to-target titration scheme, s.c. injection |
| biphasic human insulin | DRUG | Treat-to-target titration scheme, s.c. injection |
| insulin NPH | DRUG | "Soft-treat-to-target" dose titration scheme, injection s.c. |
Inclusion Criteria: * Type 2 diabetes for at least 12 months * Current biphasic human insulin (BHI) for at least 3 months - as monotherapy or as the only insulin in combination with OADs * Body Mass Index (BMI) less than or equal to 40.0 kg/m2 * HbA1c less than or equal to 9.5% * FPG (SMPG) less th...
| 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 |
EX1000 is an investigational small molecule being developed for the treatment of diabetes, specifically type 2 diabetes mellitus. It is currently in Phase 2 clinical development and has been studied in completed trials enrolling adults aged 18 years and older.
EX1000 is being developed by Novo Nordisk A/S, a pharmaceutical company listed on the stock exchange under the ticker symbol NVO. The company is conducting clinical trials to evaluate the safety and efficacy of this investigational drug in patients with type 2 diabetes.
EX1000 is in Phase 2 clinical development. Two Phase 2 trials have been completed, with a total enrollment of 799 participants. The drug is investigational and has not been approved by regulatory authorities, as it is still undergoing clinical evaluation.
EX1000 has been studied in two completed Phase 2 trials. NCT00660374 evaluated the safety and efficacy of insulin NPH compared to a new insulin formulation in 402 subjects with type 2 diabetes in Brazil. NCT00698802 compared biphasic human insulin to EX1000 in 397 subjects across India, South Africa, and the United Arab Emirates.
EX1000 is a distinct investigational drug being compared against insulin NPH and biphasic human insulin in clinical trials. It is not the same as these comparators, as the trials are designed to evaluate its safety and efficacy relative to these established insulin formulations.