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

Part of paid clinical trials in Santa Barbara, California.

Sponsor
Sansum Diabetes Research Institute
Study ID
NCT04938388
Phase
PHASE4
Status
Terminated

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Semaglutide Pill — DRUG
    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 If this minimum dose is not tolerated, the participant will be withdrawn from the study.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.
  • Fresh organic vegetables — DIETARY_SUPPLEMENT
    Prescriptions of organic vegetables

Study Details

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.

Key Dates

Start date
Jan 29, 2022
Status verified
May 2023
Primary completion
Feb 16, 2023
Completion
Feb 16, 2023

Study Design

Enrollment
12 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE

Arms

  • Active Comparator: Oral Semaglutide (OS) with Enhanced Lifestyle Care (organic vegetables)
    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.
  • Placebo Comparator: Oral Semaglutide (OS) Placebo with Enhanced Lifestyle Care (organic vegetables)
    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.

Primary Outcome Measure

HbA1c < 7.0% [ Time Frame: At 50 weeks ]

Locations (1)

FacilityCityStateZIPSite coordinators
Sansum Diabetes Research InstituteSanta BarbaraCalifornia93105-

Find similar trials in Santa Barbara, CA

By condition
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By specialty
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By research site
Sansum Diabetes Research Institute· Santa Barbara, CA

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