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EX1000 · 1 trial · 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 |
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...
EX1000 is an investigational small molecule developed by Novo Nordisk A/S for the treatment of diabetes. It is a metabolic therapy that has been studied in a Phase 2 clinical trial in patients with type 2 diabetes. EX1000 is not approved and remains in clinical development.
EX1000 is being developed for the treatment of diabetes, specifically type 2 diabetes. It was evaluated in a Phase 2 study comparing it with biphasic human insulin in adults with type 2 diabetes. EX1000 is investigational and has not been approved for any indication.
EX1000 is developed by Novo Nordisk A/S, the Danish pharmaceutical company whose shares trade under the ticker NVO. Novo Nordisk sponsored the Phase 2 clinical trial of EX1000 in type 2 diabetes. The company is the sole developer named for this asset.
EX1000 is in Phase 2 development. One Phase 2 trial has been completed, and no active trials are currently listed. The study enrolled 397 participants with type 2 diabetes. EX1000 is investigational and has not received regulatory approval.
EX1000 has been studied in one completed Phase 2 trial, NCT00698802, titled Safety and Efficacy of Biphasic Human Insulin Compared to EX1000 in Type 2 Diabetes. The trial enrolled 397 adults aged 18 and older across India, South Africa, and the United Arab Emirates and used an active-controlled, randomized design.
EX1000 is not approved. It is an investigational small molecule that has completed a Phase 2 clinical trial in type 2 diabetes and remains in clinical development. No regulatory approval has been granted for EX1000 in diabetes or any other indication.