Trial to Assess the Mechanism(s) Responsible for the Effect of the Somatostatin Analogue SOM230 (Pasireotide) in Healthy Male Volunteers

This study has been completed.
Sponsor:
Information provided by:
Veterans Medical Research Foundation
ClinicalTrials.gov Identifier:
NCT01128192
First received: September 15, 2009
Last updated: July 13, 2010
Last verified: July 2010
  Purpose

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.


Condition Intervention Phase
Hyperglycemia
Drug: pasireotide
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Double Blind (Subject, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Phase 2, Double-Blind, Randomized, Single Center Trial to Assess the Mechanism(s) Responsible for the Effect of the Somatostatin Analogue SOM230 (Pasireotide) in Healthy Male Volunteers. Version #2 05/09/2009

Resource links provided by NLM:


Further study details as provided by Veterans Medical Research Foundation:

Primary Outcome Measures:
  • To evaluate the effect of 3 dose levels of SOM230 Pasireotide (600 µg, 900 µg or 1200 µg given bid sc for 8 days) on insulin secretion, on hepatic insulin sensitivity and on peripheral insulin sensitivity in healthy non-diabetic subjects. [ Time Frame: 5 days ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • To evaluate the effect of 3 dose levels of SOM230 Pasireotide (600 µg, 900 µg or 1200 µg given bid sc for 8 days) on oral glucose absorption in healthy non-diabetic subjects. [ Time Frame: 5 days ] [ Designated as safety issue: No ]

Enrollment: 45
Study Start Date: August 2009
Study Completion Date: April 2010
Primary Completion Date: April 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: pasireotide Drug: pasireotide
600mg/900mg/1200mg double blinded BID x 5 days
Other Name: SOM230

  Eligibility

Ages Eligible for Study:   18 Years to 50 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Lean, healthy, non-diabetic male.

Exclusion Criteria:

  • Family history of diabetes, BMI over 25.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01128192

Locations
United States, California
CMR Center for Metabolic Research VASDHS
San Diego, California, United States, 92161
Sponsors and Collaborators
Veterans Medical Research Foundation
Investigators
Principal Investigator: Robert R Henry, MD Veterans Medical Research Foundation
  More Information

Additional Information:
No publications provided by Veterans Medical Research Foundation

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Robert R. Henry, M.D., Veterans Medical Research Foundation
ClinicalTrials.gov Identifier: NCT01128192     History of Changes
Other Study ID Numbers: SOM230Novartis/VMRF
Study First Received: September 15, 2009
Last Updated: July 13, 2010
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Hyperglycemia
Glucose Metabolism Disorders
Metabolic Diseases
Somatostatin
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on September 16, 2014