Mini-Dose Glucagon to Treat Non-Severe Hypoglycemia

What Was Tested

This registered phase 2 trial tested Glucagon.

It had two arms (groups): G-Pen Mini™ (glucagon injection) (experimental) and Glucose Tabs (active comparator).

The registry classes the interventions as drug and other.

More on the Plan

There are three phases included in this study: (1) Pre-crossover Trial Run-in Phase, (2) Randomized Clinical Trial (RCT) Crossover Trial Phase, and (3) Post-Crossover Trial Extension Phase. 1.

Run-in Phase: Prior to commencing the crossover trial, study enrollment will begin with a 2 week run-in phase to assess hypoglycemia eligibility and compliance. 2.

Crossover Trial Phase: The Crossover Trial Phase will consist of two (3-week) periods.

The Crossover Trial Phase will include up to 24 participants who complete these study periods.

Who Took Part

26 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 T1D and receiving daily insulin. Age: 18.0 to \< 65.0 years. Duration of T1D: ≥2.0 years. Body mass index 20.0 to \<35.0 kg/m2 and weight 110 to \<250 lbs. Using continuous glucose monitor ≥6 days/week in the last 4 weeks, with no plans to discontinue continuous glucose monitor use during the study.

The full record lists 15 inclusion and 17 exclusion criteria; among the exclusions: more than 1 severe hypoglycemic episode in the past 12 months (as defined by an episode that required third party assistance for treatment); known presence of hereditary problems of glycogen storage disease, galactose and/or lactose intolerance; use of non-insulin anti-diabetic medications.

How the Study Was Run

The set-up was randomized, crossover and open-label.

Because people in this Glucagon study were split into groups at random, differences between the groups are less likely to reflect who happened to join each one.

Each person switched between Glucagon and the comparison at some point, usually with a gap in between.

Everyone knew when Glucagon was being given (open label), which is simpler to run but leaves more room for expectations to affect what is reported.

It started in 2015-09 with completion listed for 2016-04.

It ran at 5 sites in United States (5).

Its stated primary purpose is treatment.

What Was Measured

Primary outcome: Number of Hypoglycemic Events ≥[amount hidden]/dl 15 Minutes AND ≥ [amount hidden]/dl 30 Minutes After Initial Treatment.

It also tracked 14 secondary outcomes, for example Continuous Glucose Monitor (CGM) Minimum Glucose, Event Level, CGM Maximum Glucose, Event Level, CGM Mean Glucose, Event Level, CGM Time in Range, Event Level, CGM Minimum Glucose, Event Level and CGM Maximum Glucose, Event Level.

What This Means in Plain Language

Put simply, this is a phase 2, randomized trial of Glucagon in 26 people.

Its size is small, so on its own it can only give an early look.

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.