NCT03841526

Glucagon Ready-to-Use (RTU) for Prevention of Exercise-Induced Hypoglycemia During Aerobic Exercise in Adults With T1D

Phase 2 Randomized Placebo-Controlled Double-Blind Parallel Study to Evaluate Glucagon RTU (Glucagon Injection) Compared to Standard of Care for Prevention of Exercise-Induced Hypoglycemia During Regular Aerobic Exercise in Adults With T1D

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 48 (actual)
• Sponsor: Xeris Pharmaceuticals · Industry
• Sex: All
• Age: 18 Years – 64 Years
• Healthy volunteers: Not accepted

Summary

This study is a randomized, placebo-controlled, double-blind, 2-treatment, 2-period, crossover comparison in a clinical research center (CRC) setting, followed by a randomized, placebo-controlled, double-blinded, 2-arm parallel comparison with a third open-label arm in an outpatient setting. The purpose of the study is to evaluate the preliminary efficacy and safety of Glucagon Ready-to-Use \[RTU\] to prevent exercise-induced hypoglycemia (EIH) in adults with Type 1 diabetes mellitus (T1D), who perform regular, moderate-to-high intensity aerobic exercise.

Detailed description

There were 2 phases of this study: CRC and Outpatient. The initial posting of this study reflected the 3 treatment arms included in the Outpatient Phase of the study, without including the CRC and Outpatient Phases separately. CRC Phase: The CRC Phase was comprised of 2 visits that included daytime exercise sessions at the CRC or a comparable setting. Subjects were randomized to receive their first treatment at Visit 3 and crossed over (2 to 28 day washout) to their second treatment at Visit 4. The treatments were a single treatment with 30 microliters of either Glucagon RTU (0.15 mg) or placebo with a 50% insulin pump reduction. Blood glucose was assessed 15 minutes prior to the start of exercise, at the start of exercise, and then 15, 30, 45, 60, and 75 minutes from the start of exercise. Outpatient Phase: After completion of the CRC Phase, subjects entered the 12-week Outpatient Phase. Subjects were to maintain a weekly exercise average of 2 to 3 sessions of at least 30 minutes duration. Subjects were assigned randomly in 1:1:1 ratio to administer 30 microliters of one of the following prior to the exercise sessions: Glucagon RTU (0.15 mg) with a 50% insulin pump reduction, placebo with a 50% pump reduction or Glucagon RTU (0.15 mg) without an insulin pump reduction. Blood glucose was assessed 15 minutes prior to the start of exercise, just before exercise, after 30 minutes of exercise, at the end of exercise (if longer than 30 minutes), and 30 minutes post-exercise.

Conditions

• Hypoglycemia

Interventions

Type	Name	Description
DRUG	Glucagon RTU Injection With Insulin Pump Reduction	0.15 mg injection with 50% pump reduction
OTHER	Vehicle for Glucagon RTU Injection With Insulin Pump Reduction	vehicle injection with 50% pump reduction
DRUG	Glugaon RTU Injection Without Insulin Pump Reduction	0.15 mg injection without pump reduction

Timeline

• Start date: 2019-08-22
• Primary completion: 2020-04-02
• Completion: 2020-04-02
• First posted: 2019-02-15
• Last updated: 2025-08-22
• Results posted: 2023-08-25

Locations

1 site across 1 country: Canada

Regulatory

• FDA-regulated drug study