Glucagon Ready-to-Use (RTU) for Prevention of Exercise-Induced Hypoglycemia During Aerobic Exerci… (NCT03841526) | Clinical Trial Compass
CompletedPhase 2
Glucagon Ready-to-Use (RTU) for Prevention of Exercise-Induced Hypoglycemia During Aerobic Exercise in Adults With T1D
Canada48 participantsStarted 2019-08-22
Plain-language 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.
Who can participate
Age range18 Years – 64 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
✓. Clinical diagnosis of presumed autoimmune type 1 diabetes, receiving daily insulin via continuous subcutaneous insulin infusion.
✓. Age 18 to \< 65 years.
✓. Duration of type 1 diabetes ≥ 2 years.
✓. Random C-peptide \< 0.6 ng/mL (\<198 pmol/L).
✓. Using insulin therapy by continuous subcutaneous insulin infusion pump for at least 6 months.
✓. History of exercise-related hypoglycemia.
✓. Performs aerobic exercise regularly (2-3 times per week), and desires to exercise per American Diabetes Association guidelines (150 minutes per week). Examples of aerobic exercise include: power walking, hiking, running/jogging, cycling, swimming, cross country skiing, and aerobic fitness classes.
✓. Will abstain from the use of non-insulin diabetes therapies such as sodium glucose co-transporter 2, glucagon like peptide-1, and metformin for the duration of the study.
Exclusion criteria
What they're measuring
1
Outpatient Phase: Incidence Rate of Hypoglycemia During and After Moderate to High Intensity Aerobic Exercise.
Timeframe: Daily; During the 12-week Outpatient Phase qualified exercise sessions were assessed daily and associated hypoglycemia events were assessed continuously during and within the 30 (+2) minute period following a qualified exercise session.
2
Outpatient Phase: Mean Number of Hypoglycemic Events
Timeframe: Daily; During the 12-week Outpatient Phase qualified exercise sessions were assessed daily and associated hypoglycemia events were assessed continuously throughout the 30 (+2) minute period following a qualified exercise session.
3
Outpatient Phase: Mean Number of Qualified High Intensity Aerobic Exercise Sessions
Timeframe: Daily; During the 12-week Outpatient Phase the occurrence of qualified exercise sessions were assessed daily.
. Frequently experience hyperglycemia with exercise, in the clinical judgement of the investigator.
✕. Pregnant and/ or Nursing: For female subjects of childbearing potential, there is a requirement for a negative urine pregnancy test and for agreement to use contraception and to refrain from breast feeding during the study, and for at least 1 week after the last dose of study drug. Acceptable contraception includes birth control pill / patch / vaginal ring, Depo-Provera, Norplant, an intra-uterine device, the double barrier method (the woman uses a diaphragm and spermicide and the man uses a condom), or abstinence.
✕. One or more severe hypoglycemic episodes in the past 12 months (as defined by an episode that required third party assistance for treatment).
✕. Serum alanine aminotransferase or aspartate aminotransferase equal to or greater than 3 times the upper limit of normal.
✕. Hepatic synthetic insufficiency as defined as a serum albumin of less than 3 mg/dL (0.17 mmol/L); or serum bilirubin greater than 2 mg/dL (0.11 mmol/L).