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Glucagon · 4 trials · 4 indications
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.
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.
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 (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) |
| 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 |
| 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 |
|---|---|---|
| Glucagon | DRUG | 0.5 or 1.0 mg of pre-mixed liquid Xeris glucagon delivered via auto-injector |
| Placebo | OTHER | Isotonic saline |
| 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: * diagnosed with T1D for at least 6 months at Screening. * current usage of daily insulin treatment. Exclusion Criteria: * pregnant or nursing * renal insufficiency * hepatic synthetic insufficiency * aspartate or alanine aminotransferase \> 3 times the upper limit of normal *...
Glucagon is a small molecule being developed by Xeris Biopharma Holdings, Inc. for the treatment of hypoglycemia, congenital hyperinsulinism, post-bariatric hypoglycemia, and type 1 diabetes mellitus. It is an investigational drug in clinical development, not yet approved by the FDA.
Xeris Biopharma Holdings, Inc. (NASDAQ: XERS) is developing Glucagon. The company is conducting clinical trials to evaluate its use in conditions such as hypoglycemia and type 1 diabetes.
Glucagon is in Phase 2 clinical development. It has completed trials in Phase 1, Phase 2, and Phase 3, but the most advanced completed trial is Phase 3. The drug remains investigational and is not FDA approved.
Glucagon has completed four clinical trials, including NCT02423980 for hypoglycemia rescue in type 1 diabetes patients, NCT02937558 for congenital hyperinsulinism in children, NCT03091673 for pediatric type 1 diabetes, and NCT03255629 for post-bariatric hypoglycemia. All trials were conducted in the United States.
Glucagon is also known as G-Pen in clinical trials. The G-Pen is a glucagon injection device studied in trials NCT02423980 and NCT03091673 for hypoglycemia rescue in type 1 diabetes patients.