NCT03053284

Pasireotide in Hyperinsulinemic Hypoglycemia

Pasireotide for Prevention of Hypoglycemia in Patients With Hyperinsulinemic Hypoglycemia

• Status: Withdrawn
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Montefiore Medical Center · Academic / Other
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

This is a small controlled pilot study to assess the effect of subcutaneous pasireotide on preventing hypoglycemia due to hyperinsulinism, including congenital hyperinsulinism and insulinoma.

Detailed description

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. Pasireotide is also known to decrease glucagon-like peptide 1 (GLP-1) and gastric inhibitory polypeptide (GIP) secretion. Hyperglycemia is a well-documented adverse effect of pasireotide in its approved indications for treatment of Cushing's disease and acromegaly. In light of this, the investigators hypothesize that pasireotide may be an effective therapy for hypoglycemia due to hyperinsulinism. Therefore a small controlled pilot study to assess the effect of subcutaneous (s.c.) pasireotide on preventing hypoglycemia due to hyperinsulinism over 7 hours of observation in both fasting and fed states is proposed.

Conditions

• Congenital Hyperinsulinism
• Insulinoma
• Hyperinsulinism

Interventions

Type	Name	Description
DRUG	Pasireotide 0.6Mg Solution for Injection	Pasireotide 0.6Mg Solution for Injection will be given once per study visit
DRUG	Saline Solution	Saline Solution injection will be given once per study visit

Timeline

• Start date: 2017-04-01
• Primary completion: 2018-01-01
• Completion: 2018-04-01
• First posted: 2017-02-15
• Last updated: 2021-05-14

Regulatory

• FDA-regulated drug study