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NCT02363335 · ClinicalTrials.gov registry record · Phase 1
The Role of Phosphodiesterase Inhibitors in Incretin Secretion
A Phase 1 study, sponsored by National Institute on Aging (NIA).
- Completed
- Registry status
- Phase 1
- Development phase
- 29
- Enrollment target
NCT02363335 is a Phase 1 study that has completed, run by National Institute on Aging (NIA). The registered enrollment target is 29 participants.
The verdict
NCT02363335, a Phase 1 study, has completed, sponsored by National Institute on Aging (NIA).
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 29 participants
- Enrollment target
Study Summary
Background: The drug Roflumilast (Daliresp) is used to treat Chronic Obstructive Pulmonary Disease (COPD). COPD is a lung disease that makes it difficult to breathe. Studies have shown that this drug decreased the blood sugar of people with type 2 diabetes. Sitagliptin (Januvia) is a medication presently used to treat diabetes. Researchers think that both of these drugs may decrease blood sugar by causing an increase in the hormone GLP-1.This hormone is secreted in the small intestines and stomach and is also known as an incretin. Researchers want to study how these drugs affect blood sugar, insulin, and other hormones in the blood. Objectives: * To study the effects of Roflumilast (Daliresp) and Sitagliptin (Januvia) on blood sugar and insulin. * To better understand GLP-1 and other gut hormones. This may lead to new treatments for type 2 diabetes. Eligibility: * Healthy volunteers age 21 55. * Body Mass Index (BMI) less than 30 Design: -This study will require one screening visit and four study visits, scheduled about 3-weeks apart. Screening visit requires participants to arrive after fasting for 10 hours and have the following: * Medical history, physical exam, height, weight, blood pressure measurements and blood and urine tests. * A 2-hour oral glucose tolerance test (OGTT). Participants will drink an orange-flavored drink containing 75 grams of sugar (300 calories). A blood sample will be taken prior to drinking the beverage and 2-hours later. * An electrocardiogram (EKG) to measure the electrical activity of the heart. * Questionnaires about risk for depression or suicide. Study visits 1to 4: * Participants will arrive the evening prior and blood work will be done to confirm eligibility. They will not eat or drink anything except water starting at 8:00 p.m. * About 6:30 a.m. the following day, an I.V. (small plastic tube) will be placed in an arm vein and used to take 20 blood samples over a period of about 11 hours. * Participants will receive on
Interventions
- OTHER Placebo
- OTHER Roflumilast/Sitagliptin
- OTHER Sitagliptin
- OTHER Roflumilast
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 29 participants |
| Start Date | 2015-02-13 |
| Est. Completion | 2016-09-19 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02363335
The ClinicalTrials.gov registry entry for NCT02363335 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 29 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is National Institute on Aging (NIA), which has 131 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 4 interventions - of which Placebo is the first listed.
NCT02363335 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT02363335 about?
NCT02363335 is a clinical study titled "The Role of Phosphodiesterase Inhibitors in Incretin Secretion". Background: The drug Roflumilast (Daliresp) is used to treat Chronic Obstructive Pulmonary Disease (COPD). COPD is a lung disease that makes it difficult to breathe. Studies have shown that this drug decreased the blood sugar of people with type 2 diabetes. Sitagliptin (Januvia) is a medication pre...
What is the current status of trial NCT02363335?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 29 participants. The study started on 2015-02-13. Estimated completion is 2016-09-19.
What interventions are being tested in trial NCT02363335?
The interventions under investigation include: Placebo (OTHER), Roflumilast/Sitagliptin (OTHER), Sitagliptin (OTHER), Roflumilast (OTHER).
Who is sponsoring clinical trial NCT02363335?
This trial is sponsored by National Institute on Aging (NIA), which has 131 total clinical trials registered on ClinicalTrials.gov.
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