Somatostatin Analogue SOM230 (Pasireotide) in Healthy Male Volunteers

NCT01128192 | Completed Phase 2 Results

• 1 other identifier: SOM230Novartis/VMRF
• Study Type: interventional
• Target: 45
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Hyperglycemia

Outcome Measures

Primary Outcomes (7)

• Change in Insulin Basal Level

  Change from Day 2 and Day 9 of insulin basal levels (2-step hyperglycemic clamp test with arginine stimulation)

  -30 min and -15 min on Day 2 and Day 9

• Change in Area Under the Curve (AUC) of Plasma Insulin Level 0-10mins, 10-180mins, 0-180mins During Hyperglycemic Clamp

  Blood samples were taken at -30 min, -15 min, 0 min, 15 min, 30 min, 45 min, 60 min, 75 min, 90 min, 105 min, 120 min, 135 min, 150 min, 165 min, 180 min to assess the plasma insulin levels during Hyperglycemic Clamp (2-step hyperglycemic clamp test with arginine stimulation). The mean change in plasma insulin levels from Day 2 to Day 9 were calculated as Values on Day 9 - Values on Day 2.

  0-10 mins, 10-180 mins, 0-180 mins (Day 2 and Day 9)

• Change in Basal Endogenous Glucose Production (EGP)

  Change from Day 3 and Day 10 of Basal EGP (Hyperinsulinemic-Euglycemic Clamp)

  Day 3 and Day 10

• Change in Low Dose % Endogenous Glucose Production (EGP) Inhibition

  Change from Day 3 and Day 10 of low dose % EGP Inhibition (Hyperinsulinemic-Euglycemic Clamp)

  Day 3 and Day 10

• Change in High Dose % Endogenous Glucose Production (EGP) Inhibition

  Change from Day 3 and Day 10 of high dose % EGP Inhibition (Hyperinsulinemic-Euglycemic Clamp)

  Day 3 and Day 10

• Change in Low-Dose Glucose Disposal Rate (GDR)

  Change from Day 3 and Day 10 in Low-Dose Glucose Disposal Rate (GDR) during Hyperinsulinemic-Euglycemic Clamp.

  Day 3 and Day 10

• Change in High-Dose Glucose Disposal Rate (GDR)

  Change from Day 3 and Day 10 in High-Dose Glucose Disposal Rate (GDR) during Hyperinsulinemic-Euglycemic Clamp.

  Day 3 and Day 10

Secondary Outcomes (4)

• Change in Fasting Plasma Glucose Level

  -30 minutes on Day 1 and -30 minutes on Day 8

• Change in Area Under the Curve (AUC) of Plasma Glucose 0-30mins, 30-180mins, 0-180mins During Oral Glucose Tolerance Test (OGTT)

  0-30 mins, 30-180 mins, 0-180 mins (Day 1 and Day 8)

• Change Fasting Plasma Insulin Level

  -30 minutes on Day 1 and -30 minutes on Day 8

• Change in Area Under the Curve (AUC) of Plasma Insulin 0-30mins, 30-180mins, 0-180mins During Oral Glucose Tolerance Test (OGTT)

  0-30 mins, 30-180 mins, 0-180 mins (Day 1 and Day 8)

Study Arms (3)

Pasireotide 600 µg sc bid

EXPERIMENTAL

n=19. Pasireotide 600 µg sc bid

Drug: pasireotide

Pasireotide 900 µg sc bid

EXPERIMENTAL

n=19. Pasireotide 900 µg sc bid

Drug: pasireotide

Pasireotide 1200 µg sc bid

EXPERIMENTAL

n=7. Due to increased severity of gastro-intestinal side effects, this arm was discontinued. These participants were only included in the safety analysis.

Drug: pasireotide

Interventions

pasireotide DRUG

Pasireotide 600 μg (batch number Y050DE) or 900 μg bid (batch number Y1270908) for subcutaneous injection. Placebo (batch number Y069HC) for subcutaneous injection.

Also known as: SOM230

Pasireotide 1200 µg sc bid; Pasireotide 600 µg sc bid; Pasireotide 900 µg sc bid

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Lean, healthy, non-diabetic male.

You may not qualify if:

• Family history of diabetes, BMI over 25.

Sponsors & Collaborators

• Robert R. Henry, MD: lead
• Veterans Medical Research Foundation: collaborator

Study Sites (1)

CMR Center for Metabolic Research VASDHS

San Diego, California, 92161, United States

Location

Related Publications (1)

• 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.

  PMID: 23733372 RESULT

Related Links

• Study site Web site

MeSH Terms

Conditions

Hyperglycemia

Interventions

pasireotide

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Results Point of Contact

• Title: Principal Investigator
• Organization: Veterans Medical Research Foundation

rrhenry@ucsd.edu

858-552-8585

Study Officials

• Robert R Henry, MD

  Veterans Medical Research Foundation

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Study Principal Investigator

Study Record Dates

• First Submitted: September 15, 2009
• First Posted: May 21, 2010
• Study Start: August 1, 2009
• Primary Completion: April 1, 2010
• Study Completion: April 1, 2010
• Last Updated: December 25, 2014
• Results First Posted: December 25, 2014

Record last verified: 2014-12

Locations

US (1)