Diabetes Mellitus, Type 2Phase 4NCT04938388
Comparison of Oral Semaglutide w/ Placebo- Treatment for Latino Adults w/T2 Diabetes Receiving Enhanced Lifestyle Care
A Phase 4 study testing Semaglutide Pill and Fresh organic vegetables in people with Diabetes Mellitus, Type 2 and Glucose Metabolism Disorders (Including Diabetes Mellitus), run by Sansum Diabetes Research Institute at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diabetes Mellitus, Type 2, Glucose Metabolism Disorders (Including Diabetes Mellitus)
- What is being tested?
- Semaglutide Pill and Fresh organic vegetables
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 12 participants
- Where
- 1 siteUnited States
- Study dates
- 29 Jan 2022to 16 Feb 2023
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Show all 15Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Sansum Diabetes Research Institute
Santa Barbara, California, 93105
About this study
Official title: Comparison of Oral Semaglutide With Matched Oral Semaglutide Placebo as an Early Treatment for Latino Adults With Type 2 Diabetes Receiving Enhanced Lifestyle Care
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.
Read the detailed description
Oral Semaglutide is the first oral formulation of a glucagon-like peptide-1 (GLP-1) receptor agonist developed for the treatment of type 2 diabetes (T2D). Monotherapy with once-daily oral Semaglutide has been shown to provide superior and dose-dependent decreases in HbA1c compared with placebo, and superior decreases in bodyweight in patients with T2D whose glycaemia was insufficiently controlled on diet and exercise. Recently, in patients with T2D and chronic kidney disease, Semaglutide was also effective in improving glycemic control and bodyweight with a low risk of hypoglycemia compared to placebo. Oral Semaglutide has also been shown to be superior to Sitagliptin. Results from the PIONEER 6 trial showed that no increased risk for major cardiovascular events was observed with oral Semaglutide in patients with T2D at high cardiovascular (CV) risk. In that study, Semaglutide reduced CV death and all- cause mortality by nearly 50% versus placebo after a median follow-up of 15.9 months. Therefore based on the evidence from the PIONEER trials, oral Semaglutide is likely to offer significant benefits for adults with T2D.
However in the United States (US), members of racial and ethnic minority groups are disproportionally affected by T2D and there is a paucity of information on what the potential impact of novel therapies such as oral Semaglutide might be for these populations. For example, the prevalence of both diagnosed and undiagnosed T2D is nearly twice as high among Mexican- origin Hispanic/Latino (hereafter Latino) adults compared to non-Latino whites. Likewise, rates of diabetes-related complications (including premature death from diabetes, acute stroke and end- stage renal disease) are also higher among Latino adults compared to their non-Latino white counterparts. For Latinos and other US minorities, beyond genetics and biological factors, it is recognized that sociocultural influences are also important factors in determining an individual's response to a therapy. In addition, self-identified race correlates with ancestry, which determines genomic variation, but this does not necessarily predict the response to a particular drug, nor can it be assumed that responses are similar between different races. As a corollary, being uninsured or a Medicaid recipient presents formidable challenges to improving cost-effective outcomes for people with diabetes. Currently, in the US, more than 29 million people are uninsured, with substantial inequalities in access to health care along economic, gender, racial, and ethnic lines. Racial and ethnic minority groups in the US also receive lower quality of health care compared with their white counterparts and disparities exist in the burden and cost of diabetes care for Medicare recipients. Identifying sub-groups with especially high risk of complications early in the course of T2D will also help clinicians to offer more cost-effective therapies. In addition, regulatory and policy decisions are increasingly based on a continuum of data from intensively monitored randomized clinical trials (RCTs) to real-world evidence (RWE), i.e., from tightly controlled, homogeneous populations to broader ones seen in usual clinical practice.
US minorities commonly live in "poorer" neighborhood environments with respect to access to healthy food sources, places to exercise or safety from crime. Plant-based dietary foods have the potential to help manage several major chronic diseases, including T2D. For underserved populations with T2D, food insecurity and low socioeconomic status are frequent barriers to nutrition-based self-management.
As a consequence, Sansum Diabetes Research Institute (SDRI) has recently created Farming for Life, which provides medically prescribed produce to Latino adults with non-insulin treated T2D. Farming for Life uses prescriptions of predominantly organic vegetable produce, as studies have shown that organic crops have higher concentrations of antioxidants and a lower incidence of pesticide residues than non-organic crops. There is growing evidence of an association between pesticide exposure and T2D risk.
- Being tested
- Semaglutide Pill, Fresh organic vegetables
- Keywords
- Minority Health, Plants, Edible
- Medical subject headings
- Diabetes Mellitus, Type 2, Glucose Metabolism Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Semaglutide PillDrug
Also called Semaglutide 3 mg, Semaglutide 7 mg, Semaglutide 14 mg
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 vegetablesDietary supplement
Prescriptions of organic vegetables
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Dietary Supplement: Fresh organic vegetables |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: At 50 weeks
Secondary outcomes (13)
HbA1c
Comparison with baseline (-2 weeks)
Measured: At 50 weeks
Weight
Comparison with baseline (-2 weeks)
Measured: At 50 weeks
Waist circumference
Comparison with baseline (-2 weeks)
Measured: At 50 weeks
Lying and standing blood pressure
Comparison with baseline (-2 weeks)
Measured: At 50 weeks
Fasting glucose levels
Comparison with baseline (-2 weeks)
Measured: At 50 weeks
Fasting insulin levels
Comparison with baseline (-2 weeks)
Measured: At 50 weeks
Calculation of insulin resistance (HOMA-B and HOMA-IR)
Comparison with baseline (-2 weeks)
Measured: At 50 weeks
Lipid Levels
Lipid levels- (total cholesterol, HDL-cholesterol, LDL-cholesterol and triglycerides)
Measured: Comparison with baseline (-2 weeks) and at 50 weeks
Liver Function Test
Liver Function Test (AST, ALT, Albumin)
Measured: Comparison with baseline (-2 weeks) and at 50 weeks
CGM Time In Range
Comparison of Continuous Glucose Monitoring data collected over weeks 48-49 with baseline of time in range (70-180 mg/dl) using continuous glucose monitoring
Measured: Weeks 48-49
Number of Pill Counts
Adherence to prescribed medicines- Number of Pill Counts
Measured: Comparison at 4, 8, 22, 34, and 48 weeks
Additional glucose-lowering medication (rescue medication)
The need for additional glucose-lowering medication (rescue medication) initiated by the study physician with recording of additional medication by medication name
Measured: Comparison at 4, 8, 22, 34, and 48 weeks
Number of participants with treatment-related adverse events assessed by research physician classified according to Good Clinical Practice guidelines
Participants unable to tolerate the treatment medication
Measured: Data captured at baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jun 2021
- Study start29 Jan 2022
- Primary completion16 Feb 2023
- Study completion16 Feb 2023
Why it stopped: Principal Investigator no longer at study site.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetes Mellitus, Type 2Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sansum Diabetes Research Institute
- Sponsor type
- University, hospital or other
- Collaborators
- Novo Nordisk A/S
- Responsible party
- Principal investigator, Kristin Castorino, DO, Sansum Diabetes Research Institute
- Investigators
- David Kerr, MD, Principal investigator, Sansum Diabetes Research Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04938388
- Sponsor's protocol ID
- U1111-1238-3149
- Status last verified
- May 2023
- First submitted
- 15 Jun 2021
- Last updated
- 25 May 2023
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Oral Semaglutide With Matched Oral Semaglutide Placebo as an Early Treatment for Latino Adults With Type 2 Diabetes Receiving Enhanced Lifestyle Care
- ClinicalTrials.gov ID
- NCT04938388
- Acronym / sponsor ID
- U1111-1238-3149
- Keywords
- Minority Health, Plants, Edible
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Principal Investigator no longer at study site.
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Sansum Diabetes Research InstituteUniversity, hospital or other
- Collaborators
- Novo Nordisk A/S
- Study start
- 29 Jan 2022 (actual)
- Primary completion
- 16 Feb 2023 (actual)
- Study completion
- 16 Feb 2023 (actual)
- First posted
- 24 Jun 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Oral Semaglutide is the first oral formulation of a glucagon-like peptide-1 (GLP-1) receptor agonist developed for the treatment of type 2 diabetes (T2D). Monotherapy with once-daily oral Semaglutide has been shown to provide superior and dose-dependent decreases in HbA1c compared with placebo, and superior decreases in bodyweight in patients with T2D whose glycaemia was insufficiently controlled on diet and exercise. Recently, in patients with T2D and chronic kidney disease, Semaglutide was also effective in improving glycemic control and bodyweight with a low risk of hypoglycemia compared to placebo. Oral Semaglutide has also been shown to be superior to Sitagliptin. Results from the PIONEER 6 trial showed that no increased risk for major cardiovascular events was observed with oral Semaglutide in patients with T2D at high cardiovascular (CV) risk. In that study, Semaglutide reduced CV death and all- cause mortality by nearly 50% versus placebo after a median follow-up of 15.9 months. Therefore based on the evidence from the PIONEER trials, oral Semaglutide is likely to offer significant benefits for adults with T2D.
However in the United States (US), members of racial and ethnic minority groups are disproportionally affected by T2D and there is a paucity of information on what the potential impact of novel therapies such as oral Semaglutide might be for these populations. For example, the prevalence of both diagnosed and undiagnosed T2D is nearly twice as high among Mexican- origin Hispanic/Latino (hereafter Latino) adults compared to non-Latino whites. Likewise, rates of diabetes-related complications (including premature death from diabetes, acute stroke and end- stage renal disease) are also higher among Latino adults compared to their non-Latino white counterparts. For Latinos and other US minorities, beyond genetics and biological factors, it is recognized that sociocultural influences are also important factors in determining an individual's response to a therapy. In addition, self-identified race correlates with ancestry, which determines genomic variation, but this does not necessarily predict the response to a particular drug, nor can it be assumed that responses are similar between different races. As a corollary, being uninsured or a Medicaid recipient presents formidable challenges to improving cost-effective outcomes for people with diabetes. Currently, in the US, more than 29 million people are uninsured, with substantial inequalities in access to health care along economic, gender, racial, and ethnic lines. Racial and ethnic minority groups in the US also receive lower quality of health care compared with their white counterparts and disparities exist in the burden and cost of diabetes care for Medicare recipients. Identifying sub-groups with especially high risk of complications early in the course of T2D will also help clinicians to offer more cost-effective therapies. In addition, regulatory and policy decisions are increasingly based on a continuum of data from intensively monitored randomized clinical trials (RCTs) to real-world evidence (RWE), i.e., from tightly controlled, homogeneous populations to broader ones seen in usual clinical practice.
US minorities commonly live in "poorer" neighborhood environments with respect to access to healthy food sources, places to exercise or safety from crime. Plant-based dietary foods have the potential to help manage several major chronic diseases, including T2D. For underserved populations with T2D, food insecurity and low socioeconomic status are frequent barriers to nutrition-based self-management.
As a consequence, Sansum Diabetes Research Institute (SDRI) has recently created Farming for Life, which provides medically prescribed produce to Latino adults with non-insulin treated T2D. Farming for Life uses prescriptions of predominantly organic vegetable produce, as studies have shown that organic crops have higher concentrations of antioxidants and a lower incidence of pesticide residues than non-organic crops. There is growing evidence of an association between pesticide exposure and T2D risk.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Oral Semaglutide (OS) with Enhanced Lifestyle Care (organic vegetables) | Active comparator | Drug: Semaglutide Pill, Dietary Supplement: Fresh organic vegetablesParticipants 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. |
| Oral Semaglutide (OS) Placebo with Enhanced Lifestyle Care (organic vegetables) | Placebo comparator | Dietary Supplement: Fresh organic vegetablesParticipants 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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.
Key exclusion criteria (15 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Semaglutide PillAlso: Semaglutide 3 mg, Semaglutide 7 mg, Semaglutide 14 mgAll 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. | Drug | Oral Semaglutide (OS) with Enhanced Lifestyle Care (organic vegetables) |
| Fresh organic vegetablesPrescriptions of organic vegetables | Dietary supplement | Oral Semaglutide (OS) Placebo with Enhanced Lifestyle Care (organic vegetables), Oral Semaglutide (OS) with Enhanced Lifestyle Care (organic vegetables) |
Primary outcome
HbA1c < 7.0%
Time frame: At 50 weeks
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.
13 secondary outcomes
HbA1c
Time frame: At 50 weeks
Weight
Time frame: At 50 weeks
Waist circumference
Time frame: At 50 weeks
Lying and standing blood pressure
Time frame: At 50 weeks
Fasting glucose levels
Time frame: At 50 weeks
Fasting insulin levels
Time frame: At 50 weeks
Calculation of insulin resistance (HOMA-B and HOMA-IR)
Time frame: At 50 weeks
Lipid Levels
Time frame: Comparison with baseline (-2 weeks) and at 50 weeks
Liver Function Test
Time frame: Comparison with baseline (-2 weeks) and at 50 weeks
CGM Time In Range
Time frame: Weeks 48-49
Number of Pill Counts
Time frame: Comparison at 4, 8, 22, 34, and 48 weeks
Additional glucose-lowering medication (rescue medication)
Time frame: Comparison at 4, 8, 22, 34, and 48 weeks
Number of participants with treatment-related adverse events assessed by research physician classified according to Good Clinical Practice guidelines
Time frame: Data captured at baseline
Results and safety
The study was stopped early (reason given: Principal Investigator no longer at study site.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 May 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
David Kerr, MD principal investigator
Sansum Diabetes Research Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Semaglutide Pill and Fresh organic vegetables in people with Diabetes Mellitus, Type 2 and Glucose Metabolism Disorders (Including Diabetes Mellitus), run by Sansum Diabetes Research Institute at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 25 May 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: Principal Investigator no longer at study site.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
HbA1c < 7.0% (time frame: At 50 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 May 2023.