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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT03091673 | Glucose Response of G-Pen (Glucagon Injection) in Pediatric T1D Patients | PHASE3 | COMPLETED | 31 | — | — | Mar 27, 2017 | Sep 27, 2017 | Dec 11, 2018 | 7 | United States |
The primary endpoint for this study is an evaluation of change in plasma glucose following treatment with G-Pen, with an emphasis on the increase from baseline to 30 minutes post-dosing.
| Arm | Type | Description |
|---|---|---|
| G-Pen (glucagon injection) 0.5 mg | EXPERIMENTAL | A single 0.5 mg subcutaneous (SC) injection of G-Pen (glucagon injection) |
| G-Pen (glucagon injection) 1.0 mg | EXPERIMENTAL | A single 1.0 mg subcutaneous (SC) injection of G-Pen (glucagon injection) |
| Name | Type | Description |
|---|---|---|
| Glucagon | DRUG | 0.5 or 1.0 mg of pre-mixed liquid Xeris glucagon delivered via auto-injector |
Inclusion Criteria: * diagnosed with T1D for at least 6 months at Screening. * current usage of daily insulin treatment. Exclusion Criteria: * pregnant or nursing * renal insufficiency * hepatic synthetic insufficiency * aspartate or alanine aminotransferase \> 3 times the upper limit of normal *...