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

What Was Tested

This registered phase 2 trial tested Glucagon.

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.

It had five arms (groups): one (experimental), one (placebo comparator), one (experimental), one (placebo comparator) and one (experimental).

The registry classes the interventions as drug and other.

More on the Plan

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.

Who Took Part

48 actual participants took part.

It was open to people of any sex aged from 18 years up to 64 years.

Healthy volunteers were not accepted; participants needed the condition being studied.

Examples of who could join: 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. Using insulin therapy by continuous subcutaneous insulin infusion pump for at least 6 months. History of exercise-related hypoglycemia.

The full record lists 10 inclusion and 27 exclusion criteria; among the exclusions: frequently experience hyperglycemia with exercise, in the clinical judgement of the investigator; one or more severe hypoglycemic episodes in the past 12 months (as defined by an episode that required third party assistance for treatment); uses inhaled insulin.

How the Study Was Run

Design: randomized, sequential and quadruple-blind.

Random assignment meant chance, not the researchers, decided who got Glucagon and who got the comparison, which limits bias.

Blinding on both sides kept the participants and researchers unaware of who received Glucagon.

Those kept unaware of assignments: participant, care provider, investigator and outcomes assessor.

It started in 2019-08-22 with completion listed for 2020-04-02.

It ran at 1 site in Canada.

Its stated primary purpose is treatment.

What Was Measured

Primary outcome: Outpatient Phase: Incidence Rate of Hypoglycemia During and After Moderate to High Intensity Aerobic Exercise. Outpatient Phase: Mean Number of Hypoglycemic Events. Outpatient Phase: Mean Number of Qualified High Intensity Aerobic Exercise Sessions (time frame: Daily; During the 12-week Outpatient Phase the occurrence of qualified exercise sessions were assessed daily).

It also tracked 6 secondary outcomes, for example CRC Phase: Interstitial Glucose Below Target Range, Outpatient Phase: Interstitial Glucose Levels Below Target Range, Outpatient Phase: Insulin Use Change From Baseline, Outpatient Phase: Barriers to Physical Activity Diabetes (Type 1): BAPAD-1 Change From Baseline, Outpatient Phase: HFS-II Overall Score Change From Baseline and Outpatient Phase: Hypoglycemic Confidence Scale (HCS) Change From Baseline.

What This Means in Plain Language

Put simply, this is a phase 2, randomized trial of Glucagon in 48 people.

The trial is marked completed; results are posted on the registry, and this page does not restate them.

More context: the Glucagon compound page, all human trials.