Treatment Plan for an Individual Patient With Pasireotide for Hyperinsulinemic Hypoglycemia

What Was Tested

In this phase 1 trial, researchers set out to test Pasireotide.

Somatostatin analogues are a last resort for medical intervention in hyperinsulinemic hypoglycemia (HH).

The hypoglycemia is very debilitating and can be even life threatening.

There is limited experience with pasireotide in hyperinsulinemic hypoglycemia (only one publication); there is more experience with octreotide, both in adults and children successful interventions with octreotide in hyperinsulinemic hypoglycemia have been published.

It had 1 arm (groups): pasireotide (experimental).

The registry classes the interventions as drug.

More on the Plan

Hyperinsulinemic hypoglycemia as a complication of gastric bypass surgery has been reported to occur between 6 months to 8-10 years after gastric bypass surgery.

Although reported as a rare complication from surgery, the incidence is likely higher due to the condition being missed in many patients or being misdiagnosed as dumping syndrome.

Calcium stimulation testing often localizes the area of the pancreas where hyperinsulinemia is occurring due to islet cell dysfunction.

The pathophysiology of islet cell hypertrophy with Nesidioblastosis is poorly understood.

Who Took Part

The registry lists 1 actual participants took part.

It was open to people of any sex aged from 18 years with no upper age limit.

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

Examples of who could join: Male or female patients aged 18 years or older. Patients with a confirmed diagnosis of hyperinsulinemic hypoglycemia, if possible by genetic testing. Patients not controlled by medical therapies (e.g. diazoxide or octreotide) and/or pancreatic surgery or patients not eligible for surgery. WHO/ ECOG Performance Status of 0-2. Life expectancy ≥12 weeks.

The full record lists 17 inclusion and 38 exclusion criteria; among the exclusions: patients with a known hypersensitivity to somatostatin analogs or any component of the pasireotide lar or s.c. formulations; patients currently using warfarin / warfarin derivatives; patients with symptomatic cholelithiasis.

How the Study Was Run

Design: single-group and open-label.

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

Everyone received the same intervention, so there was no separate comparison group inside the trial.

It started in 2017-03-22 with completion listed for 2017-12-22.

It ran at 1 site in United States.

Its stated primary purpose is treatment.

What Was Measured

Researchers chose this as the main measure: Recording of Hypoglycemic events (time frame: Up to 2 years).

What This Means in Plain Language

Put simply, this is a phase 1 trial of Pasireotide in 1 people.

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

The trial is marked completed; no results are posted to the registry yet, so nothing here describes outcomes.

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