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

• Status: Not yet recruiting
• Trial end date: 2023-03-14
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Sansum Diabetes Research Institute
• Collaborator: Novo Nordisk A/S

Criteria

Inclusion Criteria:

1. Individuals ≥ 18 years of age at enrollment.

2. Self-reported Hispanic/Latino heritage.

3. Established diagnosis of T2D for at least 3 months prior to enrollment date.

4. HbA1c > 7.5% and ≤ 10.0% (58-86 mmol/mol) within the previous 6 months.

5. T2D treated with lifestyle alone or lifestyle + Metformin within the past 6 months prior to screening.

6. 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.

7. 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:

1. Type 1 diabetes or a history of diabetic ketoacidosis.

2. 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.

3. Life expectancy < 12 months.

4. Any active clinically significant physical or mental disease or disorder which, in the investigator's opinion, could interfere with the participation in the study.

5. 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).

6. Untreated pre-proliferative or proliferative retinopathy or maculopathy due to diabetes.

7. Renal impairment, defined as estimated glomerular filtration rate <30 mL/min/1.73 m2.

8. Personal or family history of medullary thyroid carcinoma or Multiple Endocrine Neoplasia syndrome type 2.

9. Language barriers precluding comprehension of study activities and informed consent.

10. Participation in other research studies involving medication or device within 1 month prior to enrollment.

11. Known or suspected abuse of alcohol, narcotics, or illicit drugs.

12. Known or suspected allergy to OS, excipients, or related products.

13. Previous participation in this trial whether screened or randomized.

14. Pregnant, breast-feeding or the intention of becoming pregnant or not using adequate contraceptive measures.

15. The receipt of any investigational drug (within 12 months) prior to this trial.