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Beta
Active not recruitingPhase 4Beta 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
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 23-45•HbA1c 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
Timeline
Milestones
Assets
Investigational agents
Study populations
Who this study enrolls
Eligibility
Who can enroll
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
Weight & body composition
1 endpointChange 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 endpointsChange 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
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
- The Journal of clinical endocrinology and metabolism2020 Oct 1PMID32745202doi:10.1210/clinem/dgaa494via CT.gov background
- The American journal of cardiology2019 Dec 15PMID31741440doi:10.1016/j.amjcard.2019.10.029via CT.gov background
- The Journal of clinical endocrinology and metabolism2019 Apr 1PMID30407535doi:10.1210/jc.2018-01809via CT.gov background
- Hormone and metabolic research = Hormon- und Stoffwechselforschung = Hormones et metabolisme2006 Dec (month)PMID17163361doi:10.1055/s-2006-956505via CT.gov background
- American journal of physiology. Endocrinology and metabolism2002 Dec (month)PMID12388151doi:10.1152/ajpendo.00093.2002via CT.gov background
Provenance
Sources
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.