PK/PD Study With G-Pump (Glucagon Infusion) in T1DM Patients
Summary
The purpose of the study is to assess the safety, speed of absorption, and onset of action of G-Pump™ (glucagon infusion) at three subcutaneous doses as compared to Novo GlucaGen®, all delivered via an OmniPod® infusion pump to patients with type 1 diabetes.
Timeline
- Start
- 2014-03
- Primary completion
- 2014-08
- Completion
- 2014-09
Outcome
Missed primary endpoint
registry analysis (superiority or other test); 0.3 μg/kg G-Pump vs 0.3μg/kg GlucaGen; p = 0.23; Point estimate ratio 2.06 (90% CI 0.74 to 5.75); Mixed Models Analysis NCT02081001 ↗
registry analysis (superiority or other test); 2.0 μg/kg G-Pump vs 2.0 μg/kg GlucaGen; p = 0.02; Point estimate ratio 1.36 (90% CI 1.11 to 1.67); Mixed Models Analysis NCT02081001 ↗
release “Failure (HAAF) program as no statistically significant differences between the treatment arms were observed based on percent change in plasma epinephrine concentration from baseline.” xerispharma.com ↗
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | G-Pump | Unknown | 0.3 ug/kg | Subcutaneous |
| Subject | G-Pump | Unknown | 1.2 ug/kg | Subcutaneous |
| Subject | G-Pump | Unknown | 2 ug/kg | Subcutaneous |
| Subject | Glucagon | Peptide | 0.3 ug/kg | Subcutaneous |
| Subject | Glucagon | Peptide | 1.2 ug/kg | Subcutaneous |
| Subject | Glucagon | Peptide | 2 ug/kg | Subcutaneous |