drugset / Trial / NCT01128192

Somatostatin Analogue SOM230 (Pasireotide) in Healthy Male Volunteers

Phase 2 Completed 45 enrolled Robert R. Henry, MD Veterans Medical Research Foundation · collab

RandomizedParallel-groupDouble-blindTreatment

Summary

This clinical study will attempt to find out why in early studies in healthy volunteers, injections under the skin of pasireotide were associated with temporary increases in both fasting and post-meal glucose levels, along with possible increases in insulin and glucagon levels. Glucose refers to the amount of sugar in your blood and insulin and glucagon levels are amounts of hormones that lower and raise blood sugar. The purpose of the study is to evaluate the effects of pasireotide on insulin resistance and secretion. Insulin is a natural hormone made by the pancreas (a gland inside the abdomen) that controls the level of sugar in the blood. Insulin permits cells to use sugar for energy. Insulin resistance is the condition in which higher than normal amounts of insulin are necessary to allow the sugar to enter the cells. Insulin secretion refers to the amount of insulin produced by the body and released in the blood. Glucagon is a hormone (chemical substance produced by the pancreas gland in the body) which increases blood glucose.

Timeline

Start: 2009-08
Primary completion: 2010-04
Completion: 2010-04

Outcome

Mixed primary results

paper RESULTS: Pasireotide treatment resulted in significant decreases in insulin AUC0-180 min during both the hyperglycemic clamp test (-77.5%; P < .001 in both dose groups) PMID 23733372 ↗

registry analysis (superiority or other test); Pasireotide 600 µg sc Bid; p <0.001; ANOVA; note: Two sided P value. NCT01128192 ↗

registry analysis (superiority or other test); Pasireotide 600 µg sc Bid; p = 0.608; ANOVA; note: Two sided P value. NCT01128192 ↗

registry analysis (superiority or other test); Pasireotide 600 µg sc Bid; p = 0.178; ANOVA; note: Two sided P value. NCT01128192 ↗

paper No significant changes in hepatic or peripheral insulin sensitivity were found during the hyperinsulinemic-euglycemic clamp test. PMID 23733372 ↗

Publications

Results Henry RR, Ciaraldi TP, Armstrong D, Burke P, Ligueros-Saylan M, Mudaliar S. Hyperglycemia associated with pasireotide: results from a mechanistic study in healthy volunteers. J Clin Endocrinol Metab. 2013 Aug;98(8):3446-53. doi: 10.1210/jc.2013-1771. Epub 2013 Jun 3.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Pasireotide	Other / unclassified	600 ug	Subcutaneous
Subject	Pasireotide	Other / unclassified	900 ug	Subcutaneous
Subject	Pasireotide	Other / unclassified	1200 ug	Subcutaneous