Trial to Assess the Mechanism(s) Responsible for the Effect of the Somatostatin Analogue SOM230 (Pasireotide) in Healthy Male Volunteers
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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 |
- 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 ]
- 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 |
Inclusion Criteria:
- Lean, healthy, non-diabetic male.
Exclusion Criteria:
- Family history of diabetes, BMI over 25.
Contacts and Locations| United States, California | |
| CMR Center for Metabolic Research VASDHS | |
| San Diego, California, United States, 92161 | |
| Principal Investigator: | Robert R Henry, MD | Veterans Medical Research Foundation |
More Information
Additional Information:
No publications provided
| 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 May 22, 2013