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

NCT04938388 | Terminated Phase 4 FDA Drug

• 1 other identifier: U1111-1238-3149
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

Brief 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)

Keywords

Minority Health; Plants, Edible

Outcome Measures

Primary Outcomes (1)

• HbA1c < 7.0%

  proportion of participants achieving an HbA1c \< 7.0% at 50 weeks post-baseline in both groups (OS versus Placebo) with both groups receiving enhanced lifestyle care.

  At 50 weeks

Secondary Outcomes (13)

• HbA1c

  At 50 weeks

• Weight

  At 50 weeks

• Waist circumference

  At 50 weeks

• Lying and standing blood pressure

  At 50 weeks

• Fasting glucose levels

  At 50 weeks

Study Arms (2)

Oral Semaglutide (OS) with Enhanced Lifestyle Care (organic vegetables)

ACTIVE COMPARATOR

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.

Drug: Semaglutide Pill; Dietary Supplement: Fresh organic vegetables

Oral Semaglutide (OS) Placebo with Enhanced Lifestyle Care (organic vegetables)

PLACEBO COMPARATOR

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.

Dietary Supplement: Fresh organic vegetables

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.

Also known as: Semaglutide 3 mg, Semaglutide 7 mg, Semaglutide 14 mg

Oral Semaglutide (OS) with Enhanced Lifestyle Care (organic vegetables)

Fresh organic vegetables DIETARY_SUPPLEMENT

Prescriptions of organic vegetables

Oral Semaglutide (OS) Placebo with Enhanced Lifestyle Care (organic vegetables); Oral Semaglutide (OS) with Enhanced Lifestyle Care (organic vegetables)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Sansum Diabetes Research Institute: lead
• Novo Nordisk A/S: collaborator

Study Sites (1)

Sansum Diabetes Research Institute

Santa Barbara, California, 93105, United States

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2; Glucose Metabolism Disorders

Interventions

semaglutide

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Officials

• David Kerr, MD

  Sansum Diabetes Research Institute

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Senior Research Physician

Model Details: Single center, 56-week, randomized controlled, parallel group, double blind study comparing OS (active group) with Placebo (control group) in adult Latinos with established type 2 diabetes treated with usual diet/exercise modification alone and/or Metformin at randomization, with both groups under the supervision of the licensed SDRI study physician/Co-Investigator and also receiving enhanced lifestyle care.

Study Record Dates

• First Submitted: June 15, 2021
• First Posted: June 24, 2021
• Study Start: January 29, 2022
• Primary Completion: February 16, 2023
• Study Completion: February 16, 2023
• Last Updated: May 25, 2023

Record last verified: 2023-05

Locations

US (1)