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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: Completed Phase 2 study of Hyperglycemia, sponsored by Robert R. Henry, MD.
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. According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
Change from Day 2 and Day 9 of insulin basal levels (2-step hyperglycemic clamp test with arginine stimulation)
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 |
What the finished NCT01128192 record still lists
NCT01128192 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 45 participants, a relatively small participant target, below the 878-participant average among 38 other Hyperglycemia trials with a reported enrollment target (95% lower).
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 a single indexed study location in 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.
Learn More About Clinical Trials
Similar trials for Hyperglycemia
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT01128192's enrollment target sits among peer trials
45 22nd of 38 higher than 17 of 38 other Hyperglycemia trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Hyperglycemia trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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