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NCT02683187 · ClinicalTrials.gov registry record · Phase 1
DPP4 Inhibition & Beta Cell Function
A Phase 1 study, sponsored by David D'Alessio, M.D..
- Completed
- Registry status
- Phase 1
- Development phase
- 40
- Enrollment target
NCT02683187: Completed Phase 1 study, sponsored by David D'Alessio, M.D..
NCT02683187 is a Phase 1 study that has completed, run by David D'Alessio, M.D.. The registered enrollment target is 40 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (33% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02683187, a Phase 1 study, has completed, sponsored by David D'Alessio, M.D..
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 40 participants
- Enrollment target
Study Summary
This study is being done to determine the role of a hormone, glucagon-like peptide 1 (GLP-1), on insulin secretion and to study how GLP-1 works in in diabetic individuals as compared to non-diabetic individuals, under fasting conditions. GLP-1 is a naturally occurring hormone made in the intestines. It is released into the circulating blood after eating and helps to control the blood glucose levels by increasing insulin secretion by cells in the pancreas. However, the exact method by which GLP-1 causes insulin secretion and how GLP-1 activity is changed in diabetic persons remain unclear. This research is being done to address these questions and better understand the function of GLP-1. In this research, the investigators will use a synthetic form of Exendin-9 to determine the effects of GLP-1 on insulin secretion in diabetic and non-diabetic persons. Exendin-9 acts as a blocker of GLP-1 action, allowing us to study the specific effects of the GLP-1 hormone. Exendin-9 is an investigational compound, which means it is still being tested in research studies and is not approved by the U.S. Food and Drug Administration (FDA). In this study, the investigators will also use the drug Sitagliptin, which is an FDA-approved drug for the treatment of type 2 diabetes mellitus. In this study, use of Sitagliptin is considered investigational since it is not being used for treatment of diabetes but is instead being used to understand how GLP-1 works and to better understand how medications like Sitagliptin work in patients with type 2 diabetes mellitus.
Primary Outcome
The investigators will use the mean increment of insulin secretion rate above baseline in the 30 minutes after Arginine stimulation to integrate insulin secretion, the primary outcome measure, and 2-way ANOVA with and without Sitagliptin and Ex-9/saline at the two factors.
Interventions
- DRUG Active Comparator: Sitagliptin
- DRUG Placebo Comparator - No Sitagliptin
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 40 participants |
| Start Date | 2017-03-01 |
| Est. Completion | 2018-03-16 |
| Phase | Phase 1 |
What the finished NCT02683187 record still lists
NCT02683187 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 40 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (33% lower).
The record links to 0 conditions, and to 2 interventions - of which Active Comparator: Sitagliptin is the first listed.
NCT02683187 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02683187 about?
NCT02683187 is a clinical study titled "DPP4 Inhibition & Beta Cell Function". This study is being done to determine the role of a hormone, glucagon-like peptide 1 (GLP-1), on insulin secretion and to study how GLP-1 works in in diabetic individuals as compared to non-diabetic individuals, under fasting conditions. GLP-1 is a naturally occurring hormone made in the intestines...
What is the current status of trial NCT02683187?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 40 participants. The study started on 2017-03-01. Estimated completion is 2018-03-16.
What interventions are being tested in trial NCT02683187?
The interventions under investigation include: Active Comparator: Sitagliptin (DRUG), Placebo Comparator - No Sitagliptin (DRUG).
Who is sponsoring clinical trial NCT02683187?
This trial is sponsored by David D'Alessio, M.D., which has 4 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02683187's enrollment target sits among peer trials
40 1130th of 2000 higher than 810 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 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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