Clinical Trial Details
— Status: Terminated
Administrative data
| NCT number |
NCT04938388 |
| Other study ID # |
U1111-1238-3149 |
| Secondary ID |
|
| Status |
Terminated |
| Phase |
Phase 4
|
| First received |
|
| Last updated |
|
| Start date |
January 29, 2022 |
| Est. completion date |
February 16, 2023 |
Study information
| Verified date |
May 2023 |
| Source |
Sansum Diabetes Research Institute |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical 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. 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.
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.
