Comparison of Oral Semaglutide w/ Placebo- Treatment for Latino Adults w/T2 Diabetes Receiving Enhanced Lifestyle Care
Diabetes Mellitus, Type 2, Glucose Metabolism Disorders (Including Diabetes Mellitus)
About this trial
This is an interventional basic science trial for Diabetes Mellitus, Type 2 focused on measuring Minority Health, Plants, Edible
Eligibility Criteria
Inclusion Criteria:
- Individuals ≥ 18 years of age at enrollment.
- Self-reported Hispanic/Latino heritage.
- Established diagnosis of T2D for at least 3 months prior to enrollment date.
- HbA1c > 7.5% and ≤ 10.0% (58-86 mmol/mol) within the previous 6 months.
- T2D treated with lifestyle alone or lifestyle + Metformin within the past 6 months prior to screening.
- Ability to provide informed consent before any trial-related activities. Trial-related activities are any procedure that would not have been performed during normal management of the subject.
- Based on the research staff's judgment, participant or participant's representative must have a good understanding, ability, and willingness to adhere to the protocol, including performance of self-monitored data collection during the wearable device portion of the study.
Exclusion Criteria:
- Type 1 diabetes or a history of diabetic ketoacidosis.
- T2D treated with oral medicines other than Metformin or any injectable GLP-1 receptor agonist or insulin within the past 6 months prior to screening.
- Life expectancy < 12 months.
- Any active clinically significant physical or mental disease or disorder which, in the investigator's opinion, could interfere with the participation in the study.
- History of major surgical procedures involving the stomach potentially affecting absorption of trial product (e.g., subtotal and total gastrectomy, sleeve gastrectomy, gastric bypass surgery).
- Untreated pre-proliferative or proliferative retinopathy or maculopathy due to diabetes.
- Renal impairment, defined as estimated glomerular filtration rate <30 mL/min/1.73 m2.
- Personal or family history of medullary thyroid carcinoma or Multiple Endocrine Neoplasia syndrome type 2.
- Language barriers precluding comprehension of study activities and informed consent.
- Participation in other research studies involving medication or device within 1 month prior to enrollment.
- Known or suspected abuse of alcohol, narcotics, or illicit drugs.
- Known or suspected allergy to OS, excipients, or related products.
- Previous participation in this trial whether screened or randomized.
- Pregnant, breast-feeding or the intention of becoming pregnant or not using adequate contraceptive measures.
- The receipt of any investigational drug (within 12 months) prior to this trial.
Sites / Locations
- Sansum Diabetes Research Institute
Arms of the Study
Arm 1
Arm 2
Active Comparator
Placebo Comparator
Oral Semaglutide (OS) with Enhanced Lifestyle Care (organic vegetables)
Oral Semaglutide (OS) Placebo 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.
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.