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Trial · Interventional

Active, not recruitingPhase 4Registry data

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

Short name Beta

NCTNCT07325435 (opens ClinicalTrials.gov in a new tab)Other id1876088 SUNY Downstate MedicalOther idNew York Community Trust

Overview

Status
Active, not recruiting
Phase
Phase 4
Enrollment
60 participants (estimated)
Sponsor
MaryAnn Banerji · Other
Design
Randomized · Open label (no masking)
Countries
1 country

United States

Start
21 Dec 2024
Primary completion
31 Dec 2027 (estimated)
Completion
30 Jun 2028 (estimated)
First posted
8 Jan 2026
Last update posted
8 Jan 2026
Conditions
Type 2 Diabetes (T2DM)

Timeline

1 trial · 1 ongoing

  • Completed
  • Ongoing
  • Not yet recruiting
  • Stopped
  • Estimated dates (est.)
  • Results posted
202420252026202720282029
  1. Ph 4

    Beta

    NCT07325435

    21 Dec 2024 to est. 30 Jun 2028

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

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.

Interventions

  • SGLT-2 inhibitorDrug
  • GLP1-RADrug

Arms2

  • Active comparator

    GLP1-RA

    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.

  • Active comparator

    SGLT-2i

    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

Primary outcomes1

Outcomes the sponsor listed as primary.

  1. 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

    Registry description

    Primary Outcome Measure: The stimulated c-peptide index a primary outcome measure and is measured at baseline and 16 weeks. Change in the stimulated c-peptide index is the 16 week value minus the baseline. Higher numbers of the c-peptide index indicate better beta cell function while lower numbers indicated worse beta cell function. The stimulated c-peptide index is a calculated ratio of the c-peptide (ng/ml) to glucose levels (mg/dl) used to assess pancreatic beta cell function. It is calculated as the incremental area under the curve (AUC) of plasma C-peptide divided by the incremental AUC of plasma glucose (∆C-peptide 0-120/∆ Glucose 0-120). The outcome measure of plasma c-peptide (ng/ml) and plasma glucose (mg/dl), during the OGTT (after an overnight fast) at -15, 0, 10, 30, 45, 60, 90 and 120 minutes are combined into one primary outcome variable.

Secondary outcomes(2)
  1. 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

    Registry description

    Description: The outcome measure for glycemic control is hemoglobin A1c (%) measured at baseline and at 16 weeks. Change in hemoglobin A1c is the 16 week value minus the baseline. A negative change in hemoglobin A1c is an improvement in glucose control while a positive change suggests worsening outcomes.

  2. 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

    Registry description

    The outcome measure of body weight in Kg will be measured at baseline and 16 weeks. Change in body weight is the value at 16 weeks minus the baseline. A negative change in body weight is an improvement in weight while a positive change may suggest worsening body weight

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

No results are posted for this trial.

A trial that is still running, or that stopped early, may post results later.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies2

Studies that cite this trial.

Studies with results

2 studies on this page

Indexing hint: Randomized controlled trial · 2020

12 results

Improved Beta Cell Glucose Sensitivity Plays Predominant Role in the Decrease in HbA1c with Cana and Lira in T2DM.

Ali et al. 2020The Journal of clinical endocrinology and metabolismcited by 10

PMID 32745202DOI 10.1210/clinem/dgaa494PUB-32745202

Rights unknown12 results

Indexing hint: Randomized controlled trial · 2006

6 results

Mathematical modeling shows exenatide improved beta-cell function in patients with type 2 diabetes treated with metformin or metformin and a sulfonylurea.

Mari et al. 2006Hormone and metabolic research = Hormon- und Stoffwechselforschung = Hormones et metabolismecited by 55

PMID 17163361DOI 10.1055/s-2006-956505PUB-17163361

Full text at the publisher6 results

Eligibility

Who could join, as posted.

Sex
All
Age
from 24 Years up to 80 Years
Healthy volunteers
Not accepted
Inclusion and exclusion criteria, as posted
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.

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