SGLT-2 Inhibitors + GLP1-Receptor Agonists for Type 2 Diabetes
(Beta Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial explores how two FDA-approved diabetes medications, SGLT-2 inhibitors and GLP1-receptor agonists, affect blood sugar control in people with type 2 diabetes. The focus is on their ability to improve the function of insulin-producing cells in the pancreas. The study particularly examines how these treatments might work differently in black patients, who often face unique challenges in diabetes management. Eligible participants are black individuals who have lived with type 2 diabetes for less than 15 years, have specific blood sugar levels, and manage their condition without advanced medications. As a Phase 4 trial, this research aims to understand how these effective treatments can benefit more patients.
Will I have to stop taking my current medications?
If you are currently taking DDP-4 inhibitors, insulin, GLP-1 RA, or SGLT2-inhibitors, you will need to stop as these are not allowed in the trial. However, if you are on stable doses of metformin or metformin plus sulfonylureas, you can continue taking them.
What is the safety track record for these treatments?
Research has shown that both SGLT-2 inhibitors and GLP-1 receptor agonists are generally safe and well-tolerated for people with type 2 diabetes.
SGLT-2 inhibitors lower the risk of heart and kidney problems. For instance, they can reduce the risk of dying from heart issues by 33% and decrease the chance of kidney damage by 23%. However, they might cause problems when taken with certain other medications, so discussing them with a doctor is important.
GLP-1 receptor agonists also offer benefits. They aid in weight loss and reduce the risk of heart and kidney problems. Some studies indicate that these medications are less likely to cause low blood sugar compared to older diabetes drugs.
Both treatments have FDA approval for managing type 2 diabetes, indicating they are considered safe for this condition. Always discuss any concerns with a healthcare provider, especially regarding potential interactions with other treatments.12345Why are researchers enthusiastic about this study treatment?
Researchers are excited about SGLT-2 inhibitors and GLP1-receptor agonists for Type 2 Diabetes because they offer a dual approach that targets both blood sugar control and weight management. Unlike traditional treatments that focus primarily on lowering blood glucose levels, SGLT-2 inhibitors work by preventing glucose reabsorption in the kidneys, leading to excess glucose being excreted in urine. On the other hand, GLP1-receptor agonists mimic a hormone that increases insulin secretion and reduces appetite, which can aid in weight loss. This combination could potentially offer a more comprehensive solution to managing Type 2 Diabetes compared to existing options like metformin or sulfonylureas, which primarily target only blood sugar levels.
What evidence suggests that this trial's treatments could be effective for Type 2 Diabetes?
This trial will compare the effects of SGLT-2 inhibitors and GLP-1 receptor agonists on pancreatic beta cell function in people with type 2 diabetes. Studies have shown that SGLT-2 inhibitors greatly improve health for people with type 2 diabetes by lowering blood sugar and reducing the risk of heart-related hospital visits and deaths. Research also shows that they aid in weight loss and reduce the need for insulin. Similarly, GLP-1 receptor agonists improve blood sugar control and assist with weight loss. They also lower heart-related risks, making them a safe option for treating type 2 diabetes. Both treatments are already approved and have strong evidence supporting their effectiveness in managing diabetes.23467
Who Is on the Research Team?
Mary Ann Banerji, MD
Principal Investigator
SUNY DOwnstate Health Sciences Center, Brooklyn, New York 11203
Are You a Good Fit for This Trial?
This trial is for self-identified Black adults with recent-onset Type 2 Diabetes (diagnosed within the last 15 years), aged 24 or older, having an HbA1c level between 6.9% and 10%, a BMI greater than 23 but less than 45 kg/m2, and stable body weight over the past two months. Participants must be in good health overall.Inclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Stabilization
Participants are stabilized on diet and exercise alone, metformin alone, or metformin plus a sulfonylurea
Treatment
Participants receive randomized treatment with GLP-1 RA or SGLT-2i for 4 months
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- GLP1-RA
- SGLT-2 Inhibitor
Trial Overview
The study compares the effects of two FDA-approved diabetes medications on beta cell function: SGLT-2 inhibitors and GLP1-Receptor Agonists. It's designed to see if these drugs can differently improve insulin secretion from the pancreas, especially in Black individuals with Type 2 Diabetes.
How Is the Trial Designed?
2
Treatment groups
Active Control
We will examine the effect of SGLT-2i on pancreatic beta cell function as measured by insulin, C-peptide and glucose serum concentrations during OGTT
We will examine the effect of GLP-1 RA on pancreatic beta cell function as measured by insulin, C-peptide and glucose serum concentrations during OGTT.
Find a Clinic Near You
Who Is Running the Clinical Trial?
MaryAnn Banerji
Lead Sponsor
The New York Community Trust
Collaborator
Citations
Effectiveness and Safety of GLP-1 Receptor Agonists in ...
Conclusions: Overall, significant improvements in glycemic control, weight loss, and insulin requirements were observed with the use of GLP-1RA ...
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diabetesjournals.org
diabetesjournals.org/care/article/47/11/1873/156807/Efficacy-and-Safety-of-GLP-1-Medicines-for-Type-2Efficacy and Safety of GLP-1 Medicines for Type 2 Diabetes ...
The safety of multiple GLP-1 medicines in type 2 diabetes was studied in eight cardiovascular outcome trials, revealing a reduction in rates of ...
Comparative effectiveness of GLP-1 receptor agonists on ...
Among GLP-1RAs, semaglutide and liraglutide were associated with the greatest cardiovascular risk reduction in patients with T2D at moderate ...
GLP‐1 Receptor Agonist Therapy and Cardiorenal Outcomes ...
This study supports the use of GLP-1 RAs as a safe, effective therapeutic option for older adults with Type 2 diabetes, addressing a gap in ...
Glucagon-like receptor agonists and next-generation ...
GLP-1 receptor agonists were initially developed to treat type 2 diabetes and have had a transformative effect on its therapy, ...
GLP-1 Receptor Agonist Outcomes, Safety, and Body Mass ...
Conclusions: GLP-1 RA use in patients with type 2 diabetes on dialysis was associated with weight loss, reduced mortality risk, and increased ...
Efficacy and safety of GLP-1 agonists in the treatment ...
For hypoglycemia, liraglutide and lixisenatide significantly reduced the risk of hypoglycemia compared to traditional antidiabetic drugs (S15 ...
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