Approval Probability
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Also known as G-Pen Mini™ (glucagon injection)
G-Pen Mini · 3 trials · 2 indications
Comparison of glycemic response (from blood glucose) during exercise and early recovery between each exercise strategy.
Number of serious adverse events (SAEs) per treatment
| Arm | Type | Description |
|---|---|---|
| G-Pen Mini™ (glucagon injection) | EXPERIMENTAL | Participants are to check blood glucose (BG) with study meter once their continuous glucose monitor (CGM) reads \<70 mg/dl or they experience symptoms. Participants will be instructed to treat using mini-dose glucagon for certain phases/periods when BG is 40 to 69 mg/dl (considered a non-severe hypoglycemic event). For every event, participant will check BG with meter 3 times and treat according to protocol instructions based on BG measurement. |
| Glucose Tabs | ACTIVE_COMPARATOR | Participants are to check their blood glucose (BG) with study meter once their continuous glucose meter reads \<70 mg/dl or they experience symptoms. Participants will be instructed to treat using oral glucose tablets for certain phases/periods when BG is 40 to 69 mg/dl (considered a non-severe hypoglycemic event). For every event, participant will check BG with meter 3 times and treat according to protocol instructions based on BG measurement. |
| Control | NO_INTERVENTION | No basal insulin adjustment, no carbohydrate intake (until glucose drops \<70 mg/dL). |
| Basal insulin reduction | ACTIVE_COMPARATOR | Basal insulin reduction to 50% five minutes before the start of exercise. |
| G-Pen Mini™ (glucagon injection) 75 ug | EXPERIMENTAL | G-Pen Mini™ (glucagon injection), two 75 microgram subcutaneous injections given approximately 4-5 hours apart |
| G-Pen Mini™ (glucagon injection) 150 ug | EXPERIMENTAL | G-Pen Mini™ (glucagon injection), two 150 microgram subcutaneous injections given approximately 4-5 hours apart |
| G-Pen Mini™ (glucagon injection) 300 ug | EXPERIMENTAL | G-Pen Mini™ (glucagon injection), two 300 microgram subcutaneous injections given approximately 4-5 hours apart |
| Name | Type | Description |
|---|---|---|
| G-Pen Mini™ (glucagon injection) | DRUG | 1st BG check, 1st treatment 1. BG is 50-69 mg/dl, treatment is 150 µg of glucagon 2. BG is 40-49 mg/dl, treatment is 300 µg of glucagon 15 min later, 2nd BG check, 2nd treatment 1. BG is 60-69 mg/dl, no treatment 2. BG is 50-59 mg/dl, treatment is 150 µg of glucagon 3. BG is \<50 mg/dl, treatment is participant's preferred oral carbohydrate and not mini-dose glucagon 30 minutes later, 3rd BG check, 3rd treatment 1. BG is \>=70, no treatment 2. BG is \<70 mg/dl, treatment is participant's preferred oral carbohydrate and not mini-dose glucagon (150 µg of glucagon per syringe) |
| Glucose Tablets | OTHER | 1st BG check, 1st treatment 1. BG is 50-69 mg/dl, treatment is 15 grams of carbohydrates 2. BG is 40-49 mg/dl, treatment is 30 grams of carbohydrates 15 min later, 2nd BG check, 2nd treatment 1. BG is 60-69 mg/dl, no treatment 2. BG is 50-59 mg/dl, treatment is 15 grams of carbohydrates 3. BG is \<50 mg/dl, treatment is participant's preferred oral carbohydrate and not mini-dose glucagon 30 minutes later, 3rd BG check, 3rd treatment 1. BG is \>=70, no treatment 2. BG is \<70 mg/dl, treatment is participant's preferred oral carbohydrate and not mini-dose glucagon (5 grams of fast-acting carbohydrates (D-Glucose) per tablet) |
| Glucose Tabs | OTHER | Dextrose tabs orally (20 grams) 5 minutes before the start of exercise and at 30 minutes of exercise (total 40 grams). |
| Basal Insulin Reduction | OTHER | Basal insulin reduction to 50% 5 minutes before the start of exercise. |
Inclusion Criteria: 1. Clinical diagnosis of presumed autoimmune T1D and receiving daily insulin 2. Age: 18.0 to \< 65.0 years 3. Duration of T1D: ≥2.0 years 4. Body mass index 20.0 to \<35.0 kg/m2 and weight 110 to \<250 lbs 5. HbA1c \<8.5% (point of care or local lab, within past month) 6. Using ...
G-Pen Mini is an investigational glucagon injection developed by Xeris Biopharma Holdings, Inc. for use in type 1 diabetes and hypoglycemia. It is a small molecule product studied in Phase 2 clinical trials in the United States. It is designed for mini-dose use rather than the standard full rescue dose of glucagon.
G-Pen Mini is being studied for the prevention and treatment of hypoglycemia in people with type 1 diabetes. Its Phase 2 trials examined mini-dose glucagon to prevent exercise-induced hypoglycemia and to treat non-severe hypoglycemia. It is investigational and has not been approved for commercial use.
G-Pen Mini is developed by Xeris Biopharma Holdings, Inc., which trades on the Nasdaq under the ticker XERS. Xeris is the sponsor behind the Phase 2 clinical program evaluating mini-dose glucagon in type 1 diabetes and hypoglycemia.
G-Pen Mini is in Phase 2 development. All three of its listed clinical trials are Phase 2 studies, and all are completed, with no active trials currently recruiting. It remains an investigational product and is not FDA approved.
G-Pen Mini has been studied in three completed Phase 2 trials: NCT02660242, which tested mini-dose glucagon to prevent exercise-induced hypoglycemia in type 1 diabetes; NCT02411578, which evaluated mini-dose glucagon for non-severe hypoglycemia; and NCT02081014, a safety and efficacy study in patients with type 1 diabetes.
G-Pen Mini is also known as G-Pen Mini (glucagon injection). It is a mini-dose glucagon formulation, meaning it delivers smaller amounts of glucagon than standard emergency glucagon rescue products. The name G-Pen Mini refers to the same Xeris Biopharma Phase 2 asset.