Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
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 |
|---|---|---|
| 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. |
| Glucose Tabs | ACTIVE_COMPARATOR | Dextrose tabs orally (20 grams) five minutes before the start of exercise and at 30 minutes of exercise (total 40 grams). |
| G-Pen Mini™ (glucagon injection) | EXPERIMENTAL | Glucagon (150 µg) five minutes before the start of exercise (SQ-abdomen). |
| 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 | Glucagon (150 µg) 5 minutes before the start of exercise (SQ-abdomen). |
| 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. |
| 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) |
Inclusion Criteria: 1. Clinical diagnosis of presumed autoimmune type 1 diabetes, receiving daily insulin 2. Age 18-\<65 years 3. Duration of T1D ≥ 2 years 4. Random C-peptide \< 0.6 ng/ml 5. Using continuous subcutaneous insulin infusion (CSII; insulin pump) for at least 6 months, with no plans to...
G-Pen Mini is an investigational mini-dose glucagon product being studied for the treatment of hypoglycemia and Type 1 Diabetes Mellitus. It is designed to deliver small doses of glucagon to manage low blood sugar episodes. The drug is currently in Phase 2 clinical development and is not yet approved by regulatory authorities.
G-Pen Mini is being developed by Xeris Biopharma Holdings, Inc., a biopharmaceutical company traded on NASDAQ under the ticker symbol XERS. The company is conducting clinical trials to evaluate the safety and efficacy of this mini-dose glucagon product for managing hypoglycemia in patients with Type 1 Diabetes.
G-Pen Mini is in Phase 2 clinical development. It has completed two Phase 2 trials with a total enrollment of 42 participants. The drug is investigational and has not received FDA approval. All completed trials were active-controlled and randomized, though they were not double-blinded.
G-Pen Mini has completed three Phase 2 trials. NCT02081014 studied mini-dose glucagon in 13 patients with hypoglycemia. NCT02411578 evaluated mini-dose glucagon for non-severe hypoglycemia in 26 patients with Type 1 Diabetes. NCT02660242 examined mini-dose glucagon to prevent exercise-induced hypoglycemia in 16 patients with Type 1 Diabetes.
G-Pen Mini is a small molecule formulation of glucagon, a hormone that raises blood glucose levels. It is designed to deliver mini-doses of glucagon to treat or prevent hypoglycemia. The mechanism involves glucagon stimulating the liver to release stored glucose into the bloodstream, counteracting low blood sugar.
G-Pen Mini is a proprietary mini-dose formulation of glucagon developed by Xeris Biopharma. While it contains glucagon as the active ingredient, it is specifically designed for mini-dose delivery to manage hypoglycemia. It is not the same as standard glucagon rescue products used for severe hypoglycemia.