drugset / Trial / NCT01972152
Safety, Tolerability, Pharmacokinetic (PK) and Pharmacodynamic (PD) Study of G-Pen(TM) (Glucagon Injection) to Treat Severe Hypoglycemia
Phase 2
Completed
30 enrolled
Xeris Pharmaceuticals
Emissary International LLC · collabNational Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) · collab
RandomizedCrossoverDouble-blindTreatment
Summary
The purpose of this study is to demonstrate that G-Pen(TM) glucagon is comparable to Lilly Glucagon(TM) in terms of safety and efficacy, as a treatment for severe hypoglycemia, a complication of diabetes.
Timeline
- Start
- 2013-10
- Primary completion
- 2014-02
- Completion
- 2014-02
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | G-Pen | Unknown | 0.5 mg | Subcutaneous |
| Subject | G-Pen | Unknown | 1 mg | Subcutaneous |
| Subject | Lilly Glucagon | Unknown | 1 mg | Subcutaneous |