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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, diabetes mellitus, and type 1 diabetes. It is currently in Phase 2 clinical development for these endocrine conditions.
Glucagon is a small molecule that works by raising blood glucose levels. It is being studied for its ability to treat hypoglycemia and related conditions, including congenital hyperinsulinism and post-bariatric hypoglycemia.
Glucagon is being developed by Xeris Biopharma Holdings, Inc., a company traded on the stock exchange under the ticker symbol XERS. The company is conducting clinical trials to evaluate the drug's safety and efficacy.
Glucagon is currently in Phase 2 clinical development. It has completed one Phase 2 trial and one Phase 3 trial, but it is not yet approved by the FDA and remains an investigational drug.
Glucagon has been studied in several 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 are completed.
Glucagon is also known as G-Pen, as seen in the clinical trial titles for NCT02423980 and NCT03091673. These names refer to the same drug product being developed by Xeris Biopharma.