SGLT-2 Inhibitors + GLP1-Receptor Agonists for Type 2 Diabetes

(Beta Trial)

Age: 18+

Sex: Any

Trial Phase: Phase 4

Sponsor: MaryAnn Banerji

Must not be taking: DDP-4 inhibitors, Insulin

Disqualifiers: Poor health, Cardiovascular, Liver, Renal, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 1

Duration: 16 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

Minorities have higher rates of diabetes, poorer glucose control, and higher complications and mortality rates than white people. Several recently approved diabetes medicines improve cardiovascular and renal outcomes through two different mechanisms. This study will explore key determinants of blood glucose levels namely beta cell function after short-term randomized, parallel group treatment with FDA approved Glucagon-Like Peptide-1 Receptor Agonists¬ (GLP-1 RA), or FDA approved Sodium-Glucose co-Transporter-2 Inhibitor (SGLT-2i). Because diabetes in black people shows a unique ability to recover pancreatic insulin secretion, it is important to determine whether the effects of these drug classes differentially improve pancreatic beta cell function.

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

I agree to participate and follow all study rules.

My BMI is between 23 and 45, and my weight has been stable for 2 months.

My HbA1c level is between 6.9% and 10%.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

1 visit (in-person)

Stabilization

Participants are stabilized on diet and exercise alone, metformin alone, or metformin plus a sulfonylurea

4 weeks

Monthly visits (in-person or telephone)

Treatment

Participants receive randomized treatment with GLP-1 RA or SGLT-2i for 4 months

16 weeks

Monthly visits (in-person or telephone)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

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?

Group I: SGLT-2i Active Control 1 Intervention

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

Group II: GLP1-RA Active Control 1 Intervention

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.

Who Is Running the Clinical Trial?

MaryAnn Banerji

Lead Sponsor

The New York Community Trust

Collaborator

Trials

7

Recruited

1,200+