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NCT01128192 · ClinicalTrials.gov registry record · Phase 2
Somatostatin Analogue SOM230 (Pasireotide) in Healthy Male Volunteers
A Phase 2 study of Hyperglycemia, sponsored by Robert R. Henry, MD.
- Completed
- Registry status
- Phase 2
- Development phase
- 45
- Enrollment target
- 1
- Study location
NCT01128192 is a Phase 2 study of Hyperglycemia that has completed, run by Robert R. Henry, MD. The registered enrollment target is 45 participants, below the 878-participant average among 38 other Hyperglycemia trials with a reported enrollment target (95% lower). The trial reports 1 study location across 1 state.
The verdict
NCT01128192, a Phase 2 study of Hyperglycemia, has completed, sponsored by Robert R. Henry, MD.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 45 participants
- Enrollment target
- 1
- Study location
Study 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 Studied
Interventions
- DRUG pasireotide
Study Locations (1)
California
- CMR Center for Metabolic Research VASDHS - San Diego
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 45 participants |
| Start Date | 2009-08 |
| Est. Completion | 2010-04 |
| Phase | Phase 2 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01128192
The ClinicalTrials.gov registry entry for NCT01128192 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 45 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 878-participant average among 38 other Hyperglycemia trials with a reported enrollment target (95% lower). The listed sponsor is Robert R. Henry, MD, which has 1 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Hyperglycemia appearing as the primary indexed condition, and to 1 intervention - of which pasireotide is the first listed.
NCT01128192 reports 1 study location spanning 1 distinct geographic area - top geographies include California.
Frequently Asked Questions
What is clinical trial NCT01128192 about?
NCT01128192 is a clinical study titled "Somatostatin Analogue SOM230 (Pasireotide) in Healthy Male Volunteers". 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...
What is the current status of trial NCT01128192?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 45 participants. The study started on 2009-08. Estimated completion is 2010-04.
What conditions does trial NCT01128192 study?
This clinical trial studies the following conditions: Hyperglycemia.
What interventions are being tested in trial NCT01128192?
The interventions under investigation include: pasireotide (DRUG).
Who is sponsoring clinical trial NCT01128192?
This trial is sponsored by Robert R. Henry, MD, which has 1 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01128192 being conducted?
This trial has 1 study location across California. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Related
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