Glucagon Ready-to-Use (RTU) for Prevention of Exercise-Induced Hypoglycemia During Aerobic Exercise in Adults With T1D
Condition: Hypoglycemia
MeSH terms: Hypoglycemia
Study type: Interventional
Phase: Phase 2

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.
    

Intervention name(s): Glucagon RTU Injection With Insulin Pump Reduction; Vehicle for Glucagon RTU Injection With Insulin Pump Reduction; Glugaon RTU Injection Without Insulin Pump Reduction
Intervention type(s): Drug; Other; Drug
Intervention description(s): 0.15 mg injection with 50% pump reduction; vehicle injection with 50% pump reduction; 0.15 mg injection without pump reduction
Other intervention name(s): XP-3994; Placebo; XP-3994
Intervention MeSH terms: Insulin; Insulin, Globin Zinc; Glucagon; Glucagon-Like Peptide 1
Allocation: Randomized
Intervention model: Sequential Assignment
Intervention model description: CRC Phase: randomized, placebo-controlled, double-blind, two-treatment, two-period, crossover comparison in a clinical research center (CRC) setting. The subjects were re-randomized into the Outpatient Phase: randomized, placebo-controlled, partially double-blind, 3-arm parallel comparison in an outpatient setting.
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Exercise; Glucagon; Insulin