Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT00773279 | Efficacy, Safety and Preference Study of a Insulin Pen PDS290 vs. a Novo Nordisk Marketed Insulin Pen in Diabetics | PHASE3 | COMPLETED | 242 | — | — | Sep 1, 2008 | Jun 1, 2009 | Mar 27, 2017 | 65 | United States |
| NCT00127296 | Reliability of Dosing With NovoLog® Mix 70/30 FlexPen® Compared With Vial and Syringe | PHASE1 | COMPLETED | 60 | — | — | Jul 1, 2005 | Sep 1, 2005 | Jan 6, 2017 | 1 | United States |
| 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...