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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT02081001 | PK/PD Study With G-Pump (Glucagon Infusion) in T1DM Patients | PHASE2 | COMPLETED | 19 | — | — | Mar 1, 2014 | Sep 1, 2014 | Apr 6, 2018 | 1 | United States |
The onset of action was assessed by determining the time in minutes required to achieve 50% of the maximum plasma concentration of glucose following each dose of glucagon.
The speed of absorption was assessed by determining the time in minutes required to achieve 50% of the maximum plasma concentration of glucagon following each dose of glucagon.
| Arm | Type | Description |
|---|---|---|
| G-Pump™ (glucagon infusion) | EXPERIMENTAL | G-Pump™ (glucagon infusion); single subcutaneous infusion doses at 0.3 μg/kg, 1.2 μg/kg and 2.0 μg/kg |
| Novo Nordisk GlucaGen® | ACTIVE_COMPARATOR | Novo Nordisk GlucaGen®; single subcutaneous infusion doses 0.3 μg/kg, 1.2 μg/kg and 2.0 μg/kg |
| Name | Type | Description |
|---|---|---|
| Novo Nordisk GlucaGen® | DRUG | single subcutaneous infusion doses at 0.3 μg/kg, 1.2 μg/kg and 2.0 μg/kg |
| G-Pump™ (glucagon infusion) | DRUG | single subcutaneous infusion doses at 0.3 μg/kg, 1.2 μg/kg and 2.0 μg/kg |
Inclusion Criteria: * Males or females diagnosed with type 1 diabetes mellitus for at least 24 months * Current usage of subcutaneous insulin pump treatment * Age 18-65 years * C-peptide level \< 0.5 ng/ml * Willingness to follow all study procedures, including attending all clinic visits * Subject...