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FlexPen, vial and syringe · 2 trials · 4 indications
| Arm | Type | Description |
|---|---|---|
| PDS290 --> FlexPen® | EXPERIMENTAL | Subjects will receive trial drug with PDS290 for 12 weeks (treatment sequence 1) followed by FlexPen® for 12 weeks (treatment sequence 2) |
| FlexPen® --> PDS290 | EXPERIMENTAL | Subjects will receive trial drug with FlexPen® for 12 weeks (treatment sequence 1) followed by PDS290 for 12 weeks (treatment sequence 2) |
| Name | Type | Description |
|---|---|---|
| FlexTouch® | DEVICE | All subjects to receive insulin detemir treatment (and if relevant insulin aspart) with either a insulin pen PDS290 (FlexTouch®) or a Novo Nordisk marketed insulin pen (FlexPen®) for 12 weeks. After 12 weeks, all subjects will continue their insulin treatment with the other injection device. |
| FlexPen® | DEVICE | All subjects to receive insulin detemir treatment (and if relevant insulin aspart) with either a insulin pen PDS290 (FlexTouch®) or a Novo Nordisk marketed insulin pen (FlexPen®) for 12 weeks. After 12 weeks, all subjects will continue their insulin treatment with the other injection device. |
| vial and syringe | DEVICE | - |
Inclusion Criteria: * Informed consent obtained before any trial-related activities * Subjects diagnosed with type 1 or type 2 diabetes. If type 2 diabetics, treatment with or without oral anti diabetic medication is allowed * Current users of vial/syringe (pen naïve) treated with short-acting insu...
| 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 |
FlexPen, vial and syringe is a delivery system used in diabetes, including type 1 and type 2 diabetes mellitus. It is developed by Novo Nordisk A/S and is currently in Phase 3 clinical development. The product is designed for insulin delivery, though the specific insulin formulation is not detailed.
FlexPen, vial and syringe is developed by Novo Nordisk A/S, a pharmaceutical company traded on the NYSE under the ticker NVO. The product is in Phase 3 clinical development for diabetes, including type 1 and type 2 diabetes mellitus.
FlexPen, vial and syringe is in Phase 3 clinical development. It is an investigational product and has not been approved by regulatory authorities. Two clinical trials have been completed, including one Phase 3 study, with a total enrollment of 302 participants.
FlexPen, vial and syringe has two completed clinical trials. NCT00127296 is a Phase 1 study on dosing reliability with NovoLog Mix 70/30 FlexPen compared with vial and syringe, enrolling 60 participants. NCT00773279 is a Phase 3 study on efficacy, safety, and preference of an insulin pen, enrolling 242 participants.
FlexPen, vial and syringe is a delivery system that includes the FlexPen device and traditional vial and syringe. In clinical trial NCT00127296, the FlexPen is used with NovoLog Mix 70/30, a specific insulin formulation. The product name refers to the delivery method rather than a specific insulin.