Treatment of Low Blood Sugar With Glucagon Among Patients With Type 1 Diabetes

What Was Tested

The trial (phase 4) is built around Glucagon.

Background: Patients with type 1 diabetes (T1D) need a lifelong supply of external insulin and are advised to aim for near-normalization of blood glucose levels through intensive insulin therapy.

Aim: The purpose of this clinical study is to investigate the glycemic response to subcutaneous glucagon administration during mild hypoglycemia in T1D patients treated with insulin pump.

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

Isotonic Saline.

The registry classes the interventions as drug and other.

Who Took Part

8 planned participants were the target.

It was open to people of any sex aged from 18 years up to 65 years.

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

Examples of who could join: Males and females aged 18-65 years. Diagnosed with type 1 diabetes \> 3 years. No appearance of autonome neuropathy. Body mass index (BMI) between 20-25 kg/m2. Remained hypoglycemic awareness.

The full record lists 7 inclusion and 4 exclusion criteria; among the exclusions: allergic to glucagon or lactose; pregnancy, breast-feeding, intention of becoming pregnant, or not using adequate contraception; any disease or condition which would interfere with the subject's safety.

How the Study Was Run

The set-up was randomized, crossover and single-blind.

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.

Only one side, usually the participants, was kept unaware of whether Glucagon was given.

Those kept unaware of assignments: participant.

It started in 2014-09 with completion listed for 2015-01.

It ran at 1 site in Denmark.

Its stated primary purpose is basic science.

What Was Measured

Primary outcome: Maximum plasma glucose response (time frame: Plasma glucose measured every five minutes after administration).

It also tracked 1 secondary outcome, for example Duration of hyperglycemic effect of glucagon.

What This Means in Plain Language

Put simply, this is a phase 4, randomized trial of Glucagon in 8 people.

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

Its status is unknown; no results are posted to the registry yet, so nothing here describes outcomes.

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