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GLP-1 Receptor Agonist

Oral Semaglutide (OS) with Enhanced Lifestyle Care (organic vegetables) for Type 2 Diabetes

Phase 4
Waitlist Available
Led By David Kerr, MD
Research Sponsored by Sansum Diabetes Research Institute
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up comparison with baseline (-2 weeks) and at 50 weeks
Awards & highlights

Study Summary

This trial will help researchers learn more about how the new drug Semaglutide, affects Hispanic/Latino adults with type 2 diabetes, who eat fresh vegetables.

Eligible Conditions
  • Type 2 Diabetes
  • Diabetes Mellitus

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~data captured at baseline
This trial's timeline: 3 weeks for screening, Varies for treatment, and data captured at baseline for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
HbA1c < 7.0%
Secondary outcome measures
Additional glucose-lowering medication (rescue medication)
CGM Time In Range
Calculation of insulin resistance (HOMA-B and HOMA-IR)
+10 more

Trial Design

2Treatment groups
Active Control
Placebo Group
Group I: Oral Semaglutide (OS) with Enhanced Lifestyle Care (organic vegetables)Active Control2 Interventions
Participants will start at a 3 mg dose of OS. If this minimum dose is not tolerated, the participant will be withdrawn from the study. After 4 weeks, the OS dose will be adjusted to 7 mg. After a further 4 weeks of study and thereafter, the OS dose will be adjusted at the study physician's discretion to 14 mg. At each study visit, the current dose of OS will be maintained, unless participants report moderate-to-severe nausea or vomiting for 3 or more days in the week before the scheduled visit. If participants report moderate-to-severe nausea or vomiting, the OS dose will be maintained or decreased at the study physician's discretion. Participants will be instructed to swallow the OS tablet whole (not crushed, cut or chewed) in the morning, in a fasted state, with up to 120 mL of plain water, at least 30 minutes before any other food, beverage, or oral medication.
Group II: Oral Semaglutide (OS) Placebo with Enhanced Lifestyle Care (organic vegetables)Placebo Group1 Intervention
Participants will start at a 3 mg dose of OS matched Placebo. If this minimum dose is not tolerated, the participant will be withdrawn from the study. After 4 weeks, the Placebo will be adjusted to 7 mg. After a further 4 weeks of study and thereafter, the Placebo will be adjusted at the study physician's discretion to 14 mg. At each study visit, the current dose of Placebo will be maintained, unless participants report moderate-to-severe nausea or vomiting for 3 or more days in the week before the scheduled visit. If participants report moderate-to-severe nausea or vomiting, the Placebo will be maintained or decreased at the study physician's discretion. Participants will be instructed to swallow the matched OS Placebo whole (not crushed, cut or chewed) in the morning, in a fasted state, with up to 120 mL of plain water, at least 30 minutes before any other food, beverage, or oral medication.

Find a Location

Who is running the clinical trial?

Sansum Diabetes Research InstituteLead Sponsor
38 Previous Clinical Trials
2,266 Total Patients Enrolled
Novo Nordisk A/SIndustry Sponsor
1,514 Previous Clinical Trials
2,415,053 Total Patients Enrolled
David Kerr, MDPrincipal InvestigatorSansum Diabetes Research Institute
6 Previous Clinical Trials
1,484 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How many people are receiving treatment in this clinical trial?

"Affirmative. Clinicaltrials.gov data indicates that this clinical trial, which was created on January 29th 2022, is actively recruiting patients for participation. Approximately 100 participants will be sourced from a single location."

Answered by AI

What health issues does Oral Semaglutide (OS) with Enhanced Lifestyle Care (organic vegetables) address?

"Oral Semaglutide (OS) with Enhanced Lifestyle Care, such as consuming organic vegetables, is a popular treatment for chronic weight management. It has also been demonstrated to be efficacious in managing other health issues like reduced-calorie diet, exercise and at least one weight-related comorbid condition."

Answered by AI

Does this research endeavor have any precedential value?

"Since 2018, Novo Nordisk A/S has sponsored research on Oral Semaglutide (OS) with Enhanced Lifestyle Care (organic vegetables). After the first clinical trial in 2018 which involved 1387 participants, this drug was given its Phase 4 approval. At present time there are 58 ongoing trials for it across 55 countries and 772 cities."

Answered by AI

Is enrollment for this experiment still open to participants?

"Affirmative. Clinicaltrials.gov reveals that this investigation is currently seeking participants, with the first post date recorded as January 29th 2022 and the most recent alteration on March 7th 2022."

Answered by AI

What empirical evidence is there for the synergistic effects of OS and an organic diet?

"Currently, 58 trials investigating Oral Semaglutide (OS) paired with Enhanced Lifestyle Care (organic vegetables) are underway. Out of these, 27 have passed Phase 3 and are actively recruiting patients in 3907 locations across the United States - most notably Loma Linda, California."

Answered by AI

Has the combination of Oral Semaglutide and Enhanced Lifestyle Care (organic vegetables) been sanctioned by the U.S. Food and Drug Administration?

"Clinical trials have already established the safety of Oral Semaglutide (OS) with Enhanced Lifestyle Care (organic vegetables), allowing it to receive a score of 3."

Answered by AI

Who else is applying?

What state do they live in?
California
How old are they?
18 - 65
What portion of applicants met pre-screening criteria?
Did not meet criteria
Recent research and studies
clinicaltrials.govStudy
Comparison of Oral Semaglutide w/ Placebo- Treatment for Latino Adults w/T2 Diabetes Receiving Enhanced Lifestyle Care
Kristin Castorino, DO 2022. "Comparison of Oral Semaglutide w/ Placebo- Treatment for Latino Adults w/T2 Diabetes Receiving Enhanced Lifestyle Care". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04938388.
~4 spots leftby Apr 2025
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