Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Also known as G-Pen (glucagon injection), glucagon
G-Pen · 8 trials · 7 indications
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
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.
Number of subjects with an increase in plasma glucose concentration from below 50 mg/dL to greater than 70 mg/dL within 30 minutes after administration of glucagon
Number of subjects with an increase in plasma glucose concentration from below 50 mg/dL to greater than 70 mg/dL within 30 minutes after administration of glucagon
Number of subjects with either an increase in plasma glucose concentration from below 50 mg/dL to greater than 70 mg/dL or an increase in from baseline in plasma glucose concentration of at least 20 mg/dL within 30 minutes after administration of glucagon
Change from baseline in glucose infusion rate (GIR) will be determined for each subject at 24 and 48 hours from the start of blinded treatment. Subjects with a decrease in GIR ≥ 20% at 24 hours, and ≥ 33% at 48 hours will be considered to have had a clinically meaningful treatment response.
For 90 minutes following treatment, plasma glucose was measured every 5 minutes, with an increase in plasma glucose to \>70 mg/dL within 30 minutes of treatment being considered a positive response.
Number of serious adverse events (SAEs) per treatment group
A primary endpoint for this study is the prevention of meal provoked hypoglycemia, defined as sensor glucose levels below \<65 mg/dl, comparing study drug to control.
A primary endpoint for this study is prevention of meal provoked hypoglycemia, defined as plasma glucose levels below \<65 mg/dl, comparing study drug to control
| 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 |
| 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) |
| G-Pen first, then Lilly Glucagon | OTHER | A single 1 mg subcutaneous (SC) injection of G-Pen (glucagon injection) with a 7-28 day wash-out, followed by a single 1 mg SC injection of Lilly Glucagon (glucagon injection \[rDNA origin\]) |
| Lilly Glucagon first, then G-Pen | OTHER | A single 1 mg SC injection of Lilly Glucagon (glucagon injection \[rDNA origin\]) with a 7-28 day wash-out, followed by a single 1 mg SC injection of G-Pen (glucagon injection) |
| CSI-Glucagon (Double-Blind Phase - 2 days) | EXPERIMENTAL | Glucagon solution delivered as a continuous subcutaneous infusion via a patch pump at a starting dosage of 5 mcg/kg/hr. |
| Placebo (Double-Blind Phase - 2 days) | PLACEBO_COMPARATOR | Vehicle solution delivered as a 24-hour continuous subcutaneous infusion via a patch pump. |
| CSI-Glucagon (Open-label Phase - Up to 28 days) | EXPERIMENTAL | Glucagon solution delivered as a continuous subcutaneous infusion via a patch pump at a starting dosage of 5 mcg/kg/hr. |
| Glucagon | EXPERIMENTAL | 1 mg G-Pen™ (glucagon injection) first, followed by 0.5 mg |
| G-Pen(TM) 1 mg | EXPERIMENTAL | G-Pen(TM) (glucagon injection), single 1 mg subcutaneous (SC) injection |
| G-Pen(TM) 0.5 mg | EXPERIMENTAL | G-Pen(TM) (glucagon injection), single 0.5 mg SC injection |
| Lilly Glucagon(TM) 1 mg | ACTIVE_COMPARATOR | Lilly Glucagon(TM) \[glucagon for injection (rDNA origin)\], single 1 mg SC injection |
| Study drug (glucagon) first, placebo second | OTHER | Each subject will have two mixed meal tolerance tests performed. Each will be randomized to receive either glucagon or matched placebo during the first testing session. A participant could receive 2 doses of the study drug or placebo at each study visit. The opposite treatment will be given during the second testing session after a 1-2 week washout period. Both participants and the study team will be blinded to the intervention being used during each session. |
| Placebo first, study drug (glucagon) second | OTHER | Each subject will have two mixed meal tolerance tests performed. Each will be randomized to receive either glucagon or matched placebo during the first testing session. A participant could receive 2 doses of the study drug or placebo at each study visit. The opposite treatment will be given during the second testing session after a 1-2 week washout period. Both participants and the study team will be blinded to the intervention being used during each session. |
| 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 \[RNDA Origin\]) |
| Glucagon | DRUG | 0.5 or 1.0 mg of pre-mixed liquid Xeris glucagon delivered via auto-injector |
| G-Pen (glucagon injection) | DRUG | 1 mg of pre-mixed liquid Xeris glucagon delivered via auto-injector |
| Lilly Glucagon (glucagon injection [rDNA origin]) | DRUG | 1 mg of Lilly glucagon reconstituted from lyophilized powder |
| Placebo | OTHER | Isotonic saline |
| G-Pen(TM) 1 mg | DRUG | - |
| Lilly Glucagon(TM) 1 mg | DRUG | - |
| G-Pen(TM) 0.5 mg | DRUG | - |
| Closed loop glucagon pump | DEVICE | a novel closed-loop glucagon system (CLG) incorporating a novel, stable non-aqueous glucagon formulation together with an infusion pump system (Omnipod) guided by real-time continuous glucose monitoring (Dexcom) that is triggered by a hypoglycemia alert algorithm. |
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...
G-Pen is an investigational glucagon injection developed by Xeris Biopharma Holdings, Inc. for the rescue treatment of severe hypoglycemia, including insulin hypoglycemia, in adults with type 1 diabetes. It is a small molecule therapy administered as an injection to raise blood glucose during a low blood sugar emergency.
G-Pen is being developed for hypoglycemia rescue, specifically severe insulin hypoglycemia in adults with type 1 diabetes. The clinical program evaluated G-Pen as a ready-to-use glucagon injection for emergency treatment of low blood sugar, compared against standard glucagon rescue kits.
G-Pen is developed by Xeris Biopharma Holdings, Inc., which trades on the Nasdaq under the ticker XERS. Xeris is the sponsor of the clinical program evaluating G-Pen for hypoglycemia rescue.
G-Pen is in Phase 3 clinical development. It is investigational and has not been approved by the FDA. Xeris Biopharma conducted Phase 3 trials comparing G-Pen to standard glucagon rescue products in adults with type 1 diabetes, and the program also includes an earlier Phase 2 study.
G-Pen has been studied in completed trials including NCT03738865, which compared G-Pen to Glucagen Hypokit in 132 adults, and NCT03439072, which compared G-Pen to Lilly glucagon in 81 adults. Both were Phase 3, randomized, double-blind, active-controlled studies in type 1 diabetes.