Pasireotide in Hyperinsulinemic Hypoglycemia

What Was Tested

The trial (phase 2) is built around Pasireotide.

It had two arms (groups): Placebo (placebo comparator) and Pasireotide (experimental).

Normal saline s.c. injection once.

The registry classes the interventions as drug.

More on the Plan

Pasireotide is a somatostatin analog with affinity for several somatostatin receptors including those on pancreatic beta cells; when activated these receptors affect the secretion of glucagon and insulin.

Hyperglycemia is a well-documented adverse effect of pasireotide in its approved indications for treatment of Cushing's disease and acromegaly.

Who Took Part

It was open to people of any sex aged from 18 years up to 70 years.

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

Examples of who could join: Male or female patients aged 18 to 70 years old. Patients with hyperinsulinemic hypoglycemia due to either congenital hyperinsulinemic hypoglycemia or insulinoma, as determined by an endocrinologist. If no prior diagnosis of either insulinoma or congenital hyperinsulinemic hypoglycemia by an endocrinologist, the participant must meet the following criteria:. Written informed consent obtained prior to treatment to be consistent with local regulatory requirements. Serum total bilirubin \< 2 x ULN.

The full record lists 16 inclusion and 18 exclusion criteria; among the exclusions: age \<18, age \>70 (for both insulinoma and congenital hyperinsulinism); known hypersensitivity to somatostatin or analogues; patients who are hypothyroid and not on adequate replacement therapy.

How the Study Was Run

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

In the crossover set-up each of the participants took both Pasireotide and the comparison in turn, acting as their own control.

In this single-blind Pasireotide study one party knew the assignments and the other did not.

Those kept unaware of assignments: participant.

It started in 2017-04 with completion listed for 2018-01.

Its stated primary purpose is treatment.

What Was Measured

Primary outcome: Hypoglycemia (time frame: 7 hours).

It also tracked 1 secondary outcome, for example Serum glucose regulators.

What This Means in Plain Language

Put simply, this is a phase 2, non-randomized trial of Pasireotide in people.

It was withdrawn before enrolling anyone; no results are posted to the registry yet, so nothing here describes outcomes.

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