Pasireotide in Hyperinsulinemic Hypoglycemia

Phase 2

Withdrawn

• Conditions: Congenital Hyperinsulinism; Hyperinsulinism; Insulinoma
• Interventions: Drug: Saline Solution; Drug: Pasireotide 0.6Mg Solution for Injection

• Registration Number: NCT03053284
• Lead Sponsor: Montefiore Medical Center

Brief 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.

Study Timeline

• Study First Submitted: 2017-02-09
• Study First Submitted QC: 2017-02-14
• Study First Posted: 2017-02-15
• Study Start: 2017-04
• Primary Completion: 2018-01
• Study Completion: 2018-04
• Status Verified: 2021-05
• Last Update Submitted: 2021-05-12
• Last Update Posted: 2021-05-14

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Placebo	Saline Solution	Normal saline s.c. injection once
Pasireotide	Pasireotide 0.6Mg Solution for Injection	Pasireotide 0.6mg s.c. once

Primary Outcome Measures

Name	Time	Method
Hypoglycemia	7 hours	Occurence, frequency and severity of hypoglycemia (serum glucose \< 55 mg/dL)

Secondary Outcome Measures

Name	Time	Method
Serum glucose regulators	7 hours	Insulin, GLP-1, glucagon and cortisol levels