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Comparison of Oral Semaglutide w/ Placebo- Treatment for Latino Adults w/T2 Diabetes Receiving Enhanced Lifestyle Care

NCT04938388 · Status: TERMINATED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 12

Last updated 2023-05-25

No results posted yet for this 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.

Conditions

  • Diabetes Mellitus, Type 2
  • Glucose Metabolism Disorders (Including Diabetes Mellitus)

Interventions

DRUG

Semaglutide Pill

All participants will start at a 3 mg dose of OS or matched Placebo. If this minimum dose is not tolerated, the participant will be withdrawn from the study. After 4 weeks, the OS dose (or Placebo) will be adjusted to 7 mg. After a further 4 weeks of study and thereafter, the OS dose (or Placebo) will be adjusted at the study physician's discretion to 14 mg. At each study visit, the current dose of OS (or 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.

DIETARY_SUPPLEMENT

Fresh organic vegetables

Prescriptions of organic vegetables

Sponsors & Collaborators

  • Novo Nordisk A/S

    collaborator INDUSTRY

  • Sansum Diabetes Research Institute

    lead OTHER

Principal Investigators

  • David Kerr, MD · Sansum Diabetes Research Institute

Study Design

Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-01-29
Primary Completion
2023-02-16
Completion
2023-02-16
FDA Drug
Yes

Countries

  • United States

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04938388 on ClinicalTrials.gov