Type 2 Diabetes (T2DM)Phase 4BetaNCT07325435
Beta Cell Function in Type 2 Diabetes: Differential Effects of SGLT2 Inhibitors and GLIP-Receptor Agonists
A Phase 4 study testing SGLT-2 inhibitor and GLP1-RA in people with Type 2 Diabetes (T2DM), run by MaryAnn Banerji at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 24 to 80 years
- Conditions the study is for
- Type 2 Diabetes (T2DM)
- What is being tested?
- SGLT-2 inhibitor and GLP1-RA
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- 21 Dec 2024to 30 Jun 2028
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 24 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Agrees to participate (signs and dates the informed consent) and agrees to all study procedures and conditions of the protocol.
- Black (self-identified) patients with relatively recent onset (< 15 years) DM2
- aged >= 24 years of age (adults < age 24 years old need additional resources to consistently participate, and may have different metabolism)
- HbA1c between 6.9% and 10%, inclusive
- BMI > 23 and < 45 kg/m2, and stable body weight over 2 months
- In good general health, as evidenced by medical history and physical examination. And not having any of the specific items of the exclusion criteria.
Show all 10Show fewer
- Currently taking no diabetes medication or on stable doses (2 months) of metformin or metformin plus sulfonylureas without additional diabetes medication(s).
- Ability to take and agree to taking oral medication and to self-inject
- 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.
- Agreement to adhere to Lifestyle Considerations (see section 5.3) throughout the study, including following a diabetic diet and maintaining a physical activity program
Who cannot join
- 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.
- Current regular use of DDP-4 inhibitors, insulin or GLP-1 RA or SGLT2-inhibitors
- Currently pregnant, planned pregnancy in the next 7 months or nursing/lactating.
- Known allergic reactions to either the study medication
- 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
- Planned major surgery
Show all 11Show fewer
- Recent (within 6 months): MI, Stroke, Cerebrovascular accident or unstable angina or revascularization procedures, grade 3 or 4 heart failure
- Use of weight loss medication, weight loss surgery.
- Use of glucocorticoids for chronic illness within 8 weeks prior to screening or likely to begin glucocorticoids during study period
- Study doctor considers subject a poor study candidate
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
SUNY Downstate Health Sciences University
Brooklyn, New York, 11203
About this study
Official title: Beta Cell Function in Type 2 Diabetes in Black Patients: Differential Effects of SGLT2 Inhibitors and GLIP-Receptor Agonists
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.
Read the detailed description
Approximately 200 black people with DM2 will be screened, then stabilized on diet and exercise alone, metformin alone or metformin plus a sulfonylurea. Following stabilization, those meeting study entry criteria will be offered the treatment study with 60 randomized to 4 months of treatment with GLP-1 RA or a SGLT-2i administered according to FDA approved guidelines. After an overnight fast, an oral glucose tolerance test (OGTT) will be completed prior to randomization and after 4 months, or at earlier study termination.
Screening Visit Screening consent, medical history and physical exam (including height and weight) will be obtained, as well as baseline blood work (complete blood count, fasting glucose, A1c, lipid profile, BUN, creatinine and thyroid panel), electrocardiogram (EKG) and pregnancy test (if capable of conception).
Post-screening Visits These will occur monthly with additional visits as needed and may be by telephone or in-person, as determined by patient and staff. Adverse events, report of finger stick glucose determinations will be obtained. If in-person, weight and blood glucose (optional) will be obtained.
Final Screening Visit (In-person) Once stabilized, participants will be evaluated for whether they meet all study Inclusion Criteria and none of the study Exclusion Criteria. Weight, finger stick report, and adverse events will be obtained. Laboratory specimens (as above), EKG and pregnancy test will also be obtained.
After explanation of the study, including its voluntary nature, those meeting study entry criteria will be asked to read and sign the study consent form and scheduled for their Randomization Visit and baseline OGTT.
Randomization Visit After an over-night fast, the study's Inclusion and Exclusion Criteria will be reassessed to confirm eligibility. The 60 eligible participants will have a standard 75 mg oral glucose tolerance test (OGTT). A catheter is inserted in the forearm for the 2-3 hours with blood withdrawn through the catheter at -10 and 0 and +10, + 20, +30, +45, +60, +90 and +120 minutes. Samples will be analyzed for glucose, insulin, and C-peptide; extra blood will be stored for possible later analyses of other blood elements, such as other hormones and metabalolomics.
Month 1, 2 and 3 Visits Logs of finger sticks and weight will be obtained, as well as specific queries about possible adverse events.
Final Study Visit (Month 4 or earlier for premature ending of study) Finger stick log, weight, adverse events and end-study OGTT will be obtained, as at the Randomization Visit.
- Conditions
- Type 2 Diabetes (T2DM)
- Being tested
- SGLT-2 inhibitor, GLP1-RA
- Keywords
- Beta Cell Function, Type 2 diabetes, Black African American, Diabetes metabolism, GLP-1 receptor Agonist, SGLT-2 inhibitor, medication effects in Type 2 Diabetes
- Medical subject headings
- Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SGLT-2 inhibitorDrug
Also called empagliflozin (Jardiance®), dapagliflozin (Farxiga®), canagliflozin (Invokana®), bexagliflozin (Brenzavvy®)
SGLT-2 inhibitors block the SGLT-2 receptor
GLP1-RADrug
Also called liraglutide (Victoza), semaglutide (Ozempic), dulaglutide (Trulicity)
GLP-1 RAs stimulate the GLP-1 Receptor
| Study group | Role | What they receive |
|---|---|---|
| GLP1-RA | Active comparator | 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. Receives: Drug: GLP1-RA |
| SGLT-2i | Active comparator | 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 Receives: Drug: SGLT-2 inhibitor |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
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.
Measured: Baseline, 16 weeks
Secondary outcomes (2)
1 . Title: Change in Glycemic Control Measured at Baseline and 16 Weeks of Treatment with GLP-1 receptor Agonist or SGLT-2 Inhibitors
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.
Measured: Baseline, 16 weeks
Change in Body Weight from Baseline and 16 Weeks of Treatment with GLP-1 receptor Agonist or SGLT-2 inhibitors
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
Measured: Baseline, 16 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jan 2026
- Study start21 Dec 2024
- Primary completion31 Dec 2027 (estimated)
- Study completion30 Jun 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (11)Papers the sponsor has linked to this study.
- Other trials for Type 2 Diabetes (T2DM)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants will be randomized to marketed SGLT-2 inhibitors including empafliflozin or dapagliflozin versus GLP-1 receptor agonists (semaglutide, liraglutide or dulaglutide). The specific member of the class will determined by insurance copberage, pharmacy availablility or patient preference.
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- MaryAnn Banerji
- Sponsor type
- University, hospital or other
- Collaborators
- The New York Community Trust
- Responsible party
- Sponsor-investigator, MaryAnn Banerji, State University of New York - Downstate Medical Center
- Investigators
- Mary Ann Banerji, MD, Principal investigator, SUNY DOwnstate Health Sciences Center, Brooklyn, New York 11203
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07325435
- Sponsor's protocol ID
- 1876088 SUNY Downstate Medical
- Other IDs
- New York Community Trust
- Acronym
- Beta
- Status last verified
- Jan 2026
- First submitted
- 18 Dec 2025
- Last updated
- 8 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No: IRB approval is not for data sharing.
Publications
McGill JB, Subramanian S. Safety of Sodium-Glucose Co-Transporter 2 Inhibitors. Am J Cardiol. 2019 Dec 15;124 Suppl 1:S45-S52. doi: 10.1016/j.amjcard.2019.10.029.
PubMed 31741440Ali AM, Mari A, Martinez R, Al-Jobori H, Adams J, Triplitt C, DeFronzo R, Cersosimo E, Abdul-Ghani M. Improved Beta Cell Glucose Sensitivity Plays Predominant Role in the Decrease in HbA1c with Cana and Lira in T2DM. J Clin Endocrinol Metab. 2020 Oct 1;105(10):dgaa494. doi: 10.1210/clinem/dgaa494.
PubMed 32745202Mari A, Nielsen LL, Nanayakkara N, DeFronzo RA, Ferrannini E, Halseth A. Mathematical modeling shows exenatide improved beta-cell function in patients with type 2 diabetes treated with metformin or metformin and a sulfonylurea. Horm Metab Res. 2006 Dec;38(12):838-44. doi: 10.1055/s-2006-956505.
PubMed 17163361Mari A, Schmitz O, Gastaldelli A, Oestergaard T, Nyholm B, Ferrannini E. Meal and oral glucose tests for assessment of beta -cell function: modeling analysis in normal subjects. Am J Physiol Endocrinol Metab. 2002 Dec;283(6):E1159-66. doi: 10.1152/ajpendo.00093.2002. Epub 2002 Aug 6.
PubMed 12388151Mari A, Tura A, Gastaldelli A, Ferrannini E. Assessing insulin secretion by modeling in multiple-meal tests: role of potentiation. Diabetes. 2002 Feb;51 Suppl 1:S221-6. doi: 10.2337/diabetes.51.2007.s221.
PubMed 11815483Rasouli N, Younes N, Utzschneider KM, Inzucchi SE, Balasubramanyam A, Cherrington AL, Ismail-Beigi F, Cohen RM, Olson DE, DeFronzo RA, Herman WH, Lachin JM, Kahn SE; GRADE Research Group. Association of Baseline Characteristics With Insulin Sensitivity and beta-Cell Function in the Glycemia Reduction Approaches in Diabetes: A Comparative Effectiveness (GRADE) Study Cohort. Diabetes Care. 2021 Feb;44(2):340-349. doi: 10.2337/dc20-1787. Epub 2020 Dec 17.
PubMed 33334808Defronzo RA. Banting Lecture. From the triumvirate to the ominous octet: a new paradigm for the treatment of type 2 diabetes mellitus. Diabetes. 2009 Apr;58(4):773-95. doi: 10.2337/db09-9028. No abstract available.
PubMed 19336687Banerji MA, Chaiken RL, Huey H, Tuomi T, Norin AJ, Mackay IR, Rowley MJ, Zimmet PZ, Lebovitz HE. GAD antibody negative NIDDM in adult black subjects with diabetic ketoacidosis and increased frequency of human leukocyte antigen DR3 and DR4. Flatbush diabetes. Diabetes. 1994 Jun;43(6):741-5. doi: 10.2337/diab.43.6.741.
PubMed 8194658Banerji MA, Chaiken RL, Lebovitz HE. Long-term normoglycemic remission in black newly diagnosed NIDDM subjects. Diabetes. 1996 Mar;45(3):337-41. doi: 10.2337/diab.45.3.337.
PubMed 8593939Hakim O, Bonadonna RC, Mohandas C, Billoo Z, Sunderland A, Boselli L, Alberti KGMM, Peacock JL, Umpleby AM, Charles-Edwards G, Amiel SA, Goff LM. Associations Between Pancreatic Lipids and beta-Cell Function in Black African and White European Men With Type 2 Diabetes. J Clin Endocrinol Metab. 2019 Apr 1;104(4):1201-1210. doi: 10.1210/jc.2018-01809.
PubMed 30407535Banerji MA, Chaiken RL, Gordon D, Kral JG, Lebovitz HE. Does intra-abdominal adipose tissue in black men determine whether NIDDM is insulin-resistant or insulin-sensitive? Diabetes. 1995 Feb;44(2):141-6. doi: 10.2337/diab.44.2.141.
PubMed 7859931
Study at a glance
From the registry record, last updated by the sponsor on 8 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Beta Cell Function in Type 2 Diabetes in Black Patients: Differential Effects of SGLT2 Inhibitors and GLIP-Receptor Agonists
- ClinicalTrials.gov ID
- NCT07325435
- Acronym / sponsor ID
- Beta / 1876088 SUNY Downstate Medical
- Conditions
- Type 2 Diabetes (T2DM)
- Keywords
- Beta Cell Function, Type 2 diabetes, Black African American, Diabetes metabolism, GLP-1 receptor Agonist, SGLT-2 inhibitor, medication effects in Type 2 Diabetes
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- MaryAnn BanerjiUniversity, hospital or other
- Collaborators
- The New York Community Trust
- Study start
- 21 Dec 2024 (actual)
- Primary completion
- 31 Dec 2027 (estimated)
- Study completion
- 30 Jun 2028 (estimated)
- First posted
- 8 Jan 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Approximately 200 black people with DM2 will be screened, then stabilized on diet and exercise alone, metformin alone or metformin plus a sulfonylurea. Following stabilization, those meeting study entry criteria will be offered the treatment study with 60 randomized to 4 months of treatment with GLP-1 RA or a SGLT-2i administered according to FDA approved guidelines. After an overnight fast, an oral glucose tolerance test (OGTT) will be completed prior to randomization and after 4 months, or at earlier study termination.
Screening Visit Screening consent, medical history and physical exam (including height and weight) will be obtained, as well as baseline blood work (complete blood count, fasting glucose, A1c, lipid profile, BUN, creatinine and thyroid panel), electrocardiogram (EKG) and pregnancy test (if capable of conception).
Post-screening Visits These will occur monthly with additional visits as needed and may be by telephone or in-person, as determined by patient and staff. Adverse events, report of finger stick glucose determinations will be obtained. If in-person, weight and blood glucose (optional) will be obtained.
Final Screening Visit (In-person) Once stabilized, participants will be evaluated for whether they meet all study Inclusion Criteria and none of the study Exclusion Criteria. Weight, finger stick report, and adverse events will be obtained. Laboratory specimens (as above), EKG and pregnancy test will also be obtained.
After explanation of the study, including its voluntary nature, those meeting study entry criteria will be asked to read and sign the study consent form and scheduled for their Randomization Visit and baseline OGTT.
Randomization Visit After an over-night fast, the study's Inclusion and Exclusion Criteria will be reassessed to confirm eligibility. The 60 eligible participants will have a standard 75 mg oral glucose tolerance test (OGTT). A catheter is inserted in the forearm for the 2-3 hours with blood withdrawn through the catheter at -10 and 0 and +10, + 20, +30, +45, +60, +90 and +120 minutes. Samples will be analyzed for glucose, insulin, and C-peptide; extra blood will be stored for possible later analyses of other blood elements, such as other hormones and metabalolomics.
Month 1, 2 and 3 Visits Logs of finger sticks and weight will be obtained, as well as specific queries about possible adverse events.
Final Study Visit (Month 4 or earlier for premature ending of study) Finger stick log, weight, adverse events and end-study OGTT will be obtained, as at the Randomization Visit.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Participants will be randomized to marketed SGLT-2 inhibitors including empafliflozin or dapagliflozin versus GLP-1 receptor agonists (semaglutide, liraglutide or dulaglutide). The specific member of the class will determined by insurance copberage, pharmacy availablility or patient preference.
| Arm | Type | Receives |
|---|---|---|
| GLP1-RA | Active comparator | Drug: GLP1-RAWe 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. |
| SGLT-2i | Active comparator | Drug: SGLT-2 inhibitorWe will examine the effect of SGLT-2i on pancreatic beta cell function as measured by insulin, C-peptide and glucose serum concentrations during OGTT |
Who may qualify
- Ages
- 24 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Agrees to participate (signs and dates the informed consent) and agrees to all study procedures and conditions of the protocol.
- Black (self-identified) patients with relatively recent onset (< 15 years) DM2
- aged >= 24 years of age (adults < age 24 years old need additional resources to consistently participate, and may have different metabolism)
- HbA1c between 6.9% and 10%, inclusive
- BMI > 23 and < 45 kg/m2, and stable body weight over 2 months
Key exclusion criteria (11 listed)
- 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.
- Current regular use of DDP-4 inhibitors, insulin or GLP-1 RA or SGLT2-inhibitors
- Currently pregnant, planned pregnancy in the next 7 months or nursing/lactating.
- Known allergic reactions to either the study medication
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SGLT-2 inhibitorAlso: empagliflozin (Jardiance®), dapagliflozin (Farxiga®), canagliflozin (Invokana®), bexagliflozin (Brenzavvy®)SGLT-2 inhibitors block the SGLT-2 receptor | Drug | SGLT-2i |
| GLP1-RAAlso: liraglutide (Victoza), semaglutide (Ozempic), dulaglutide (Trulicity)GLP-1 RAs stimulate the GLP-1 Receptor | Drug | GLP1-RA |
Primary outcome
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
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.
2 secondary outcomes
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
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jan 2026.
- Background: PubMed 31741440McGill JB, Subramanian S. Safety of Sodium-Glucose Co-Transporter 2 Inhibitors. Am J Cardiol. 2019 Dec 15;124 Suppl 1:S45-S52. doi: 10.1016/j.amjcard.2019.10.029.
- Background: PubMed 32745202Ali AM, Mari A, Martinez R, Al-Jobori H, Adams J, Triplitt C, DeFronzo R, Cersosimo E, Abdul-Ghani M. Improved Beta Cell Glucose Sensitivity Plays Predominant Role in the Decrease in HbA1c with Cana and Lira in T2DM. J Clin Endocrinol Metab. 2020 Oct 1;105(10):dgaa494. doi: 10.1210/clinem/dgaa494.
- Background: PubMed 17163361Mari A, Nielsen LL, Nanayakkara N, DeFronzo RA, Ferrannini E, Halseth A. Mathematical modeling shows exenatide improved beta-cell function in patients with type 2 diabetes treated with metformin or metformin and a sulfonylurea. Horm Metab Res. 2006 Dec;38(12):838-44. doi: 10.1055/s-2006-956505.
- Background: PubMed 12388151Mari A, Schmitz O, Gastaldelli A, Oestergaard T, Nyholm B, Ferrannini E. Meal and oral glucose tests for assessment of beta -cell function: modeling analysis in normal subjects. Am J Physiol Endocrinol Metab. 2002 Dec;283(6):E1159-66. doi: 10.1152/ajpendo.00093.2002. Epub 2002 Aug 6.
- Background: PubMed 11815483Mari A, Tura A, Gastaldelli A, Ferrannini E. Assessing insulin secretion by modeling in multiple-meal tests: role of potentiation. Diabetes. 2002 Feb;51 Suppl 1:S221-6. doi: 10.2337/diabetes.51.2007.s221.
- Background: PubMed 33334808Rasouli N, Younes N, Utzschneider KM, Inzucchi SE, Balasubramanyam A, Cherrington AL, Ismail-Beigi F, Cohen RM, Olson DE, DeFronzo RA, Herman WH, Lachin JM, Kahn SE; GRADE Research Group. Association of Baseline Characteristics With Insulin Sensitivity and beta-Cell Function in the Glycemia Reduction Approaches in Diabetes: A Comparative Effectiveness (GRADE) Study Cohort. Diabetes Care. 2021 Feb;44(2):340-349. doi: 10.2337/dc20-1787. Epub 2020 Dec 17.
- Background: PubMed 19336687Defronzo RA. Banting Lecture. From the triumvirate to the ominous octet: a new paradigm for the treatment of type 2 diabetes mellitus. Diabetes. 2009 Apr;58(4):773-95. doi: 10.2337/db09-9028. No abstract available.
- Background: PubMed 8194658Banerji MA, Chaiken RL, Huey H, Tuomi T, Norin AJ, Mackay IR, Rowley MJ, Zimmet PZ, Lebovitz HE. GAD antibody negative NIDDM in adult black subjects with diabetic ketoacidosis and increased frequency of human leukocyte antigen DR3 and DR4. Flatbush diabetes. Diabetes. 1994 Jun;43(6):741-5. doi: 10.2337/diab.43.6.741.
- Background: PubMed 8593939Banerji MA, Chaiken RL, Lebovitz HE. Long-term normoglycemic remission in black newly diagnosed NIDDM subjects. Diabetes. 1996 Mar;45(3):337-41. doi: 10.2337/diab.45.3.337.
- Background: PubMed 30407535Hakim O, Bonadonna RC, Mohandas C, Billoo Z, Sunderland A, Boselli L, Alberti KGMM, Peacock JL, Umpleby AM, Charles-Edwards G, Amiel SA, Goff LM. Associations Between Pancreatic Lipids and beta-Cell Function in Black African and White European Men With Type 2 Diabetes. J Clin Endocrinol Metab. 2019 Apr 1;104(4):1201-1210. doi: 10.1210/jc.2018-01809.
- Background: PubMed 7859931Banerji MA, Chaiken RL, Gordon D, Kral JG, Lebovitz HE. Does intra-abdominal adipose tissue in black men determine whether NIDDM is insulin-resistant or insulin-sensitive? Diabetes. 1995 Feb;44(2):141-6. doi: 10.2337/diab.44.2.141.
- accessdataFDA.gov ( PDRs) of the medicine EmpagliflozinLink provided by the sponsor.
- accessdataFDA.gov ( PDRs) of the medicine liraglutide.Link provided by the sponsor.
- accessdataFDA.gov ( PDRs) of the medicine semaglutide.Link provided by the sponsor.
- Individual participant dataSharing planned: No. IRB approval is not for data sharing.
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A Study to Evaluate ALN-4324 in Overweight to Obese Healthy Volunteers and in Overweight to Obese Patients With T2DM
Obese or Overweight Healthy Volunteers, Type 2 Diabetes Mellitus (T2DM)
Active, not recruiting
The GRoceries Aimed at Increasing Nutrition Study
Type 2 Diabetes, Type II Diabetes Mellitus
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mary Ann Banerji, MD principal investigator
SUNY DOwnstate Health Sciences Center, Brooklyn, New York 11203
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing SGLT-2 inhibitor and GLP1-RA in people with Type 2 Diabetes (T2DM), run by MaryAnn Banerji at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 8 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07325435, which also lists 11 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Jan 2026.