Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Glucagon RTU With Insulin Pump Reduction · 1 trial · 1 indication
Mean incidence rate of hypoglycemia during and after sessions of moderate to high intensity aerobic exercise in 12-week Outpatient Phase. Incidence rate is defined as the number of hypoglycemic events divided by the total number of qualified exercise sessions, assessed at group level. Qualified exercise session is: (1) confirmed blood glucose of 100-180 mg/dL prior to start of exercise, (2) self-administered study drug no more than 10 min prior to exercise (5 min target), (3) conducted a protocol allowed exercise of moderate to high intensity for at least 30 min and no longer than 75 min, and (4) achieved a target heart rate of 80% of maximum calculated heart rate at least once during session. Exercise sessions were to occur at least 2-3 times per week. Only 1 qualified exercise session/subject/day was included in the analysis (the first if \>1). Hypoglycemic event defined as any hypoglycemic event occurring within 30 (+2) min after completion of a qualified exercise session.
Outpatient Phase: Mean number of hypoglycemic events associated with the qualified exercise sessions, assessed at group level. A qualified exercise session was defined as one were (1) a confirmed blood glucose value of 100-180 mg/dL prior to start of exercise, (2) self-administered the study drug no more than 10 minutes prior to exercise (5 minutes was the target), (3) conducted a protocol allowed exercise for moderate to high intensity for at least 30 minutes and no longer than 75 minutes, and (4) achieved a target heart rate of 80% of maximum calculated heart rate at least once during the session. A hypoglycemic event was defined as any hypoglycemic event occurring during or within 30 (+2) minutes after completion of a qualified exercise session. Exercise sessions were expected to occur at least 2 to 3 times per week. Only 1 qualified exercise session per subject per day was included in the analysis (the first if \>1).
Outpatient Phase: Mean number of qualified exercise sessions, assessed at group level. A qualified exercise session was defined as one were (1) a confirmed blood glucose value of 100-180 mg/dL prior to start of exercise, (2) self-administered the study drug no more than 10 minutes prior to exercise (5 minutes was the target), (3) conducted a protocol allowed exercise for moderate to high intensity for at least 30 minutes and no longer than 75 minutes, and (4) achieved a target heart rate of 80% of maximum calculated heart rate at least once during the session. Exercise sessions were expected to occur at least 2 to 3 times per week. Only 1 qualified exercise session per subject per day was included in the analysis (the first if \>1).
| Arm | Type | Description |
|---|---|---|
| CRC Phase: Glucagon RTU With Insulin Pump Reduction | EXPERIMENTAL | CRC Phase: 2-arm randomized double-blind crossover, Glucagon RTU Injection 30 microliters of 0.15 mg injection with 50% reduction in the insulin pump |
| CRC Phase: Vehicle for Glucagon RTU With Insulin Pump Reduction | PLACEBO_COMPARATOR | CRC Phase: 2-arm randomized double-blind crossover, Vehicle for Glucagon RTU Injection 30 microliters vehicle with 50% reduction in the insulin pump |
| Outpatient Phase: Glucagon RTU With Insulin Pump Reduction | EXPERIMENTAL | Outpatient Phase: 3-arm randomized comparison (2-arm double-blind, 1-arm open-label), Glucagon RTU Injection 30 microliters of 0.15 mg injection with 50% reduction in the insulin pump (double-blind arm) |
| Outpatient Phase: Vehicle for Glucagon RTU With Insulin Pump Reduction | PLACEBO_COMPARATOR | Outpatient Phase: 3-arm randomized comparison (2-arm double-blind, 1-arm open-label), Vehicle for Glucagon RTU Injection 30 microliters vehicle with 50% reduction in the insulin pump (double-blind arm) |
| Outpatient Phase: Glucagon RTU Without Insulin Pump Reduction | EXPERIMENTAL | Outpatient Phase: 3-arm randomized comparison (2-arm double-blind, 1-arm open-label), Glucagon RTU Injection 30 microliters of 0.15 mg injection without a reduction in the insulin pump (open-label arm) |
| Name | Type | Description |
|---|---|---|
| Glucagon RTU Injection With Insulin Pump Reduction | DRUG | 0.15 mg injection with 50% pump reduction |
| Vehicle for Glucagon RTU Injection With Insulin Pump Reduction | OTHER | vehicle injection with 50% pump reduction |
| Glugaon RTU Injection Without Insulin Pump Reduction | DRUG | 0.15 mg injection without pump reduction |
Inclusion Criteria: 1. Clinical diagnosis of presumed autoimmune type 1 diabetes, receiving daily insulin via continuous subcutaneous insulin infusion. 2. Age 18 to \< 65 years. 3. Duration of type 1 diabetes ≥ 2 years. 4. Random C-peptide \< 0.6 ng/mL (\<198 pmol/L). 5. Using insulin therapy by co...
Glucagon RTU is an investigational ready-to-use glucagon formulation being studied for hyperinsulinemic hypoglycemia and hypoglycemia. It is being evaluated for use in patients with hyperinsulinemic hypoglycemia after bariatric surgery and for prevention of exercise-induced hypoglycemia in adults with type 1 diabetes.
Glucagon RTU is being developed by Xeris Biopharma Holdings, Inc., a company traded on the stock exchange under the ticker XERS. The company is conducting clinical trials to evaluate the drug's safety and efficacy in metabolic conditions.
Glucagon RTU is in Phase 2 clinical development. It is an investigational drug, meaning it has not been approved by regulatory authorities and is still undergoing clinical trials to assess its safety and effectiveness for treating hypoglycemia-related conditions.
Glucagon RTU has been studied in two completed Phase 2 trials. NCT03770637 evaluated the drug in patients with hyperinsulinemic hypoglycemia after bariatric surgery in the United States. NCT03841526 assessed its use for preventing exercise-induced hypoglycemia in adults with type 1 diabetes in Canada.
Glucagon RTU is a ready-to-use formulation of glucagon, a hormone that raises blood sugar. Unlike traditional glucagon emergency kits that require mixing before injection, this formulation is designed to be used directly without reconstitution, potentially offering greater convenience for managing hypoglycemia.