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Beta

Active not recruitingPhase 4

Beta Cell Function in Type 2 Diabetes: Differential Effects of SGLT2 Inhibitors and GLIP-Receptor Agonists

Beta Cell Function in Type 2 Diabetes in Black Patients: Differential Effects of SGLT2 Inhibitors and GLIP-Receptor Agonists

Lead sponsor

MaryAnn Banerji

Assets

Dulaglutide / GLP-1 / incretin class catch-all / Liraglutide / Semaglutide

Listed sites

1

Recruiting sites

Enrollment

60

estimated

Study population

Type 2 diabetes

Key I/E criteria

BMI 23-45HbA1c 6.9-10%

Primary endpoint

Stimulated C-peptide Index during an Oral Glucose Tolerance Test is a measure

Footprint

Where this trial recruits

Site locations as reported to ClinicalTrials.gov. Site count is not enrollment count; per-site enrollment is not available from source.

Identifiers

Registered as

NCT IDNCT07325435
Org study ID1876088 SUNY Downstate Medical
Secondary IDNew York Community TrustNew York Community Trust

Timeline

Milestones

Study start2024-12-21actual
Study first posted2026-01-08actual
Last update posted2026-01-08actual
Primary completion2027-12-31estimated
Study completion2028-06-30estimated

Assets

Investigational agents

Study populations

Who this study enrolls

Type 2 diabetes

Eligibility

Who can enroll

Minimum age24 Years
Maximum age80 Years
SexAll
Healthy volunteersNot accepted

Inclusion criteria

1. Agrees to participate (signs and dates the informed consent) and agrees to all study procedures and conditions of the protocol.

2. Black (self-identified) patients with relatively recent onset (< 15 years) DM2

3. aged >= 24 years of age (adults < age 24 years old need additional resources to consistently participate, and may have different metabolism)

4. HbA1c between 6.9% and 10%, inclusive

5. BMI > 23 and < 45 kg/m2, and stable body weight over 2 months

6. In good general health, as evidenced by medical history and physical examination. And not having any of the specific items of the exclusion criteria.

7. Currently taking no diabetes medication or on stable doses (2 months) of metformin or metformin plus sulfonylureas without additional diabetes medication(s).

8. Ability to take and agree to taking oral medication and to self-inject

9. For persons of reproductive potential: negative pregnancy test, use of effective contraception for at least 1 month prior to screening, and agreement to use such a method during study participation, and for an additional 4 weeks after completing the use of the study drug. They will be counseled that if they wish to become pregnant, they should follow the standard practice of optimizing their blood glucose in preparation for pregnancy. Use of these study drugs are not considered standard of care for diabetes during pregnancy. Effective contraception includes tubal ligation, hysterectomy, oral, implanted or injected contraceptives, mechanical (IUD) and barriers (diaphragm, condoms, spermicides) methods.

10. Agreement to adhere to Lifestyle Considerations (see section 5.3) throughout the study, including following a diabetic diet and maintaining a physical activity program

Exclusion criteria

1. Poor general health, low kidney function (eGFR < 45), abnormal liver blood tests (AST and ALT > 3 times the ULN, Bilirubin 2 x ULN), serious cardiovascular, liver or renal disease, known proliferative retinopathy, type 1 diabetes, pancreatitis or pancreas cancer, medullary thyroid cancer, MEN2 (or family history of MEN2), current low hematocrit (< 35% for men and 33% for women, frailty, at risk for falls, current (past six months) alcohol or substance use disorder, history of a non-traumatic bone fracture, amputation, organ transplant, HIV or COVID, or if the patient cannot complete study activities.

2. Current regular use of DDP-4 inhibitors, insulin or GLP-1 RA or SGLT2-inhibitors

3. Currently pregnant, planned pregnancy in the next 7 months or nursing/lactating.

4. Known allergic reactions to either the study medication

5. Treatment with another investigational drug or other intervention within 4 months, or plan to enroll in another interventional study during their participation in this study

6. Planned major surgery

7. Recent (within 6 months): MI, Stroke, Cerebrovascular accident or unstable angina or revascularization procedures, grade 3 or 4 heart failure

8. Use of weight loss medication, weight loss surgery.

9. Use of glucocorticoids for chronic illness within 8 weeks prior to screening or likely to begin glucocorticoids during study period

10. Study doctor considers subject a poor study candidate

11. Cancer - History of active or untreated malignancy or in remission from a clinically significant malignancy for < 5 years; exception: basal cell carcinoma of the skin.

Endpoints (3)

What's being measured

Protocol endpoints and posted registry outcome measures, grouped into outcome categories. Composite endpoints show their component event types. Standard codes (LOINC, SNOMED CT) are shown where available.

Coverage by outcome category

Glycemic / diabetes
2
Weight & body composition
1

Weight & body composition

1 endpoint
Secondary/protocol endpoint

Change in Body Weight from Baseline and 16 Weeks of Treatment with GLP-1 receptor Agonist or SGLT-2 inhibitors

Time frame:Baseline, 16 weeks

Body weight, absolute change (kg)

change from baseline, improvement

Glycemic / diabetes

2 endpoints
Primary/protocol endpoint

Change in Stimulated C-peptide Index during an Oral Glucose Tolerance Test is a measure of Beta Cell Function and will be measuresd at baseline and at 16 weeks after treatment with GLP-1 Receptor Agonist or SGLT2-Inhibitor

Time frame:Baseline, 16 weeks

change from baseline, improvement

Secondary/protocol endpoint

1 . Title: Change in Glycemic Control Measured at Baseline and 16 Weeks of Treatment with GLP-1 receptor Agonist or SGLT-2 Inhibitors

Time frame:Baseline, 16 weeks

HbA1c, change

change from baseline, improvement

LOINC 4548-4

Publications (11)

Bibliography

Records linked to this trial through ClinicalTrials.gov references, PubMed NCT search, and curated study seeds. 'Canonical' marks design/result papers; others are registry references or candidates.

Registry references + supporting bibliography

Provenance

Sources

Trial identity, design, statusClinicalTrials.gov API v2
Snapshot dateJuly 1, 2026
Endpoint classificationDelfa endpoint taxonomy v2 (May 13, 2026)
Results tableno registry results posted yet

Trial facts come from public ClinicalTrials.gov records. Endpoint categories are Delfa's classification of those records, not a ClinicalTrials.gov field. All figures reflect the July 1, 2026 snapshot.