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

What this study is testing ClinicalTrials.gov NCT04938388 ↗

Description as written by the study sponsor.

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.

Treatments tested

• Semaglutide Pill also known as Semaglutide 3 mg, Semaglutide 7 mg, Semaglutide 14 mg 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 If this minimum dose is not tolerated, the participant will be withdrawn from the study.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