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NCT07325435 · ClinicalTrials.gov registry record · Phase 4
Beta Cell Function in Type 2 Diabetes: Differential Effects of SGLT2 Inhibitors and GLIP-Receptor Agonists
A Phase 4 study of Type 2 Diabetes (T2DM), sponsored by MaryAnn Banerji.
- Active
- Registry status
- Phase 4
- Development phase
- 60
- Enrollment target
- 1
- Study location
NCT07325435: Active Phase 4 study of Type 2 Diabetes (T2DM), sponsored by MaryAnn Banerji.
NCT07325435 is a Phase 4 study of Type 2 Diabetes (T2DM) that is active but no longer recruiting, run by MaryAnn Banerji. The registered enrollment target is 60 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (88% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT07325435, a Phase 4 study of Type 2 Diabetes (T2DM), is active but no longer recruiting, sponsored by MaryAnn Banerji.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 4
- Development phase
- 60 participants
- Enrollment target
- 1
- Study location
Study 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. 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.
Primary Outcome
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 calcula
Conditions Studied
Interventions
- DRUG SGLT-2 inhibitor
- DRUG GLP1-RA
Study Locations (1)
New York
- SUNY Downstate Health Sciences University - Brooklyn
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 60 participants |
| Start Date | 2024-12-21 |
| Est. Completion | 2028-06-30 |
| Phase | Phase 4 |
What the registry record for NCT07325435 still lists
NCT07325435 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 60 participants, a relatively small participant target, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (88% lower).
The record links to 1 condition, with Type 2 Diabetes (T2DM) appearing as the primary indexed condition, and to 2 interventions - of which SGLT-2 inhibitor is the first listed.
NCT07325435 reports a single indexed study location in New York.
Frequently Asked Questions
What is clinical trial NCT07325435 about?
NCT07325435 is a clinical study titled "Beta Cell Function in Type 2 Diabetes: 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...
What is the current status of trial NCT07325435?
This trial is currently active not recruiting. It is a Phase 4 study. The enrollment target is 60 participants. The study started on 2024-12-21. Estimated completion is 2028-06-30.
What conditions does trial NCT07325435 study?
This clinical trial studies the following conditions: Type 2 Diabetes (T2DM).
What interventions are being tested in trial NCT07325435?
The interventions under investigation include: SGLT-2 inhibitor (DRUG), GLP1-RA (DRUG).
Who is sponsoring clinical trial NCT07325435?
This trial is sponsored by MaryAnn Banerji, which has 1 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT07325435 being conducted?
This trial has 1 study location across New York. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT07325435's enrollment target sits among peer trials
60 1125th of 2000 higher than 800 of 2,000 other Phase 4 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 4 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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