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NCT04938388 · ClinicalTrials.gov registry record · Phase 4
Comparison of Oral Semaglutide w/ Placebo- Treatment for Latino Adults w/T2 Diabetes Receiving Enhanced Lifestyle Care
A Phase 4 study, sponsored by Sansum Diabetes Research Institute.
- Terminated
- Registry status
- Phase 4
- Development phase
- 12
- Enrollment target
NCT04938388: Clinical Trial Phase 4 study, sponsored by Sansum Diabetes Research Institute.
NCT04938388 is a Phase 4 study that was terminated before completion, run by Sansum Diabetes Research Institute. The registered enrollment target is 12 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (98% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04938388, a Phase 4 study, was terminated before completion, sponsored by Sansum Diabetes Research Institute.
- TERMINATED
- Registry status
- Phase 4
- Development phase
- 12 participants
- Enrollment target
Study Summary
Researchers at Sansum Diabetes Research Institute want to learn more about how taking a new approved drug called oral Semaglutide, while eating fresh vegetables, impacts health in Hispanic/Latino adults with type 2 diabetes. This study drug is approved by the United States Food and Drug Administration and may be available by prescription for type 2 diabetes. To do this, 100 Hispanic/Latino adults who have type 2 diabetes will be split into two groups. Over one year, one group will take Semaglutide pills and the other group will take a placebo (a dummy pill that looks just like the real Semaglutide pill but does not contain the active drug). Neither the participants nor the study investigator nor the study doctor will know who is taking the real pill and who is taking the placebo. In case of an emergency, however, the study investigator and doctor can get this information. All participants will receive pills and vegetables every two weeks, have their health assessed by study staff, and meet with the study doctor six times over the course of the study. Participant weight, height, waist circumference, blood pressure, and blood glucose levels will be measured. Participants will also wear monitors to measure blood glucose, physical activity and sleep. Study staff will also ask questions about participant health, medications, mood, sleep, pain, exercise, diet, acculturation, household, language, and trust in doctors.
Primary Outcome
proportion of participants achieving an HbA1c \< 7.0% at 50 weeks post-baseline in both groups (OS versus Placebo) with both groups receiving enhanced lifestyle care.
Interventions
- DIETARY_SUPPLEMENT Fresh organic vegetables
- DRUG Semaglutide Pill
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 12 participants |
| Start Date | 2022-01-29 |
| Est. Completion | 2023-02-16 |
| Phase | Phase 4 |
Why NCT04938388 stopped before completion
NCT04938388 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 12 participants, a relatively small participant target, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (98% lower).
The record links to 0 conditions, and to 2 interventions - of which Fresh organic vegetables is the first listed.
NCT04938388 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04938388 about?
NCT04938388 is a clinical study titled "Comparison of Oral Semaglutide w/ Placebo- Treatment for Latino Adults w/T2 Diabetes Receiving Enhanced Lifestyle Care". Researchers at Sansum Diabetes Research Institute want to learn more about how taking a new approved drug called oral Semaglutide, while eating fresh vegetables, impacts health in Hispanic/Latino adults with type 2 diabetes. This study drug is approved by the United States Food and Drug Administrati...
What is the current status of trial NCT04938388?
This trial is currently terminated. It is a Phase 4 study. The enrollment target is 12 participants. The study started on 2022-01-29. Estimated completion is 2023-02-16.
What interventions are being tested in trial NCT04938388?
The interventions under investigation include: Fresh organic vegetables (DIETARY_SUPPLEMENT), Semaglutide Pill (DRUG).
Who is sponsoring clinical trial NCT04938388?
This trial is sponsored by Sansum Diabetes Research Institute, which has 33 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04938388's enrollment target sits among peer trials
12 1913th of 2000 higher than 70 of 2,000 other Phase 4 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 4 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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