Clinical Trial: Pasireotide in Hyperinsulinemic Hypoglycemia

Study Status: Not yet recruiting
Recruit Status: Not yet recruiting
Study Type: Interventional

Official Title: Pasireotide for Prevention of Hypoglycemia in Patients With Hyperinsulinemic Hypoglycemia

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 Summary:

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.


Sponsor: Montefiore Medical Center

Current Primary Outcome: Hypoglycemia [ Time Frame: 7 hours ]

Occurence, frequency and severity of hypoglycemia (serum glucose < 55 mg/dL)


Original Primary Outcome: Same as current

Current Secondary Outcome: Serum glucose regulators [ Time Frame: 7 hours ]

Insulin, GLP-1, glucagon and cortisol levels


Original Secondary Outcome: Same as current

Information By: Montefiore Medical Center

Dates:
Date Received: February 9, 2017
Date Started: April 2017
Date Completion: April 2018
Last Updated: February 14, 2017
Last Verified: November 2016