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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT03738865 | G-Pen Compared to Glucagen Hypokit for Severe Hypoglycemia Rescue in Adults With Type 1 Diabetes | PHASE3 | COMPLETED | 132 | — | — | Sep 27, 2018 | Apr 2, 2019 | May 22, 2020 | 7 | United States, Austria +1 |
| NCT03439072 | G-Pen™ Compared to Lilly Glucagon for Hypoglycemia Rescue in Adults With Type 1 Diabetes | PHASE3 | COMPLETED | 81 | — | — | Jan 23, 2018 | May 3, 2018 | Feb 17, 2020 | 6 | United States, Canada |
Number of subjects with an increase in plasma glucose concentration from below 54 mg/dL (3 mmol/L) to greater than 70 mg/dL (3.89 mmol/L) or an increase in plasma glucose concentration \> 20 mg/dL (\> 1.11 mmol/L) within 30 minutes after administration of glucagon
Increase in plasma glucose concentration from below 50.0 mg/dL to greater than 70.0 mg/dL within 30 minutes after receiving glucagon
| Arm | Type | Description |
|---|---|---|
| G-Pen followed by Novo Glucagon | EXPERIMENTAL | 1 mg G-Pen at the first treatment visit followed by 1 mg Novo Glucagon at the second treatment visit |
| Novo Glucagon followed by G-Pen | ACTIVE_COMPARATOR | 1 mg Novo Glucagon at the first treatment visit followed by 1 mg G-Pen at the second treatment visit |
| G-Pen followed by Lilly Glucagon | OTHER | 1 mg G-Pen at the first treatment visit followed by 1 mg Lilly Glucagon at the second treatment visit |
| Lilly Glucagon followed by G-Pen | OTHER | 1 mg Lilly Glucagon at the first treatment visit followed by 1 mg G-Pen at the second treatment visit |
| Name | Type | Description |
|---|---|---|
| G-Pen | DRUG | 1 mg subcutaneous injection of G-Pen (glucagon injection) administered via auto-injector |
| Novo Glucagon | DRUG | 1 mg subcutaneous injection of Novo Glucagon (glucagon injection) |
| Lilly Glucagon | DRUG | 1 mg subcutaneous injection of Lilly Glucagon (glucagon injection \[RNDA Origin\]) |
Inclusion Criteria: 1. Males and non-pregnant females diagnosed with type 1 diabetes (T1D) for at least 24 months. 2. Current usage of daily insulin treatment that includes having an assigned "correction factor" for managing hyperglycemia. 3. Age 18 to 75 years, inclusive. 4. Random serum C-peptide...