Clinical Research Directory

Safety and Efficacy of Canagliflozin in Patients With Locally Advanced or Advanced Solid Cancer

\*\*Revised version:\*\* Locally advanced or advanced solid tumors remain a major clinical challenge despite multimodal treatments, including surgery, radiotherapy, chemotherapy, targeted therapy, and immunotherapy. For patients with unresectable, recurrent, metastatic, or treatment-refractory disease, prognosis remains poor, and effective therapeutic strategies are still urgently needed. Immune checkpoint inhibitors (ICIs), particularly PD-1/PD-L1 blockade, have transformed the treatment landscape of multiple solid tumors by reinvigorating anti-tumor immune responses through inhibition of the PD-1/PD-L1 pathway. However, only a subset of patients derive durable benefit from immunotherapy, and primary or acquired resistance remains common, highlighting the need for rational combination strategies to enhance anti-tumor efficacy. Intriguingly, sodium-glucose cotransporter 2 inhibitors, originally developed as anti-diabetic agents, have shown emerging anti-tumor potential through metabolic regulation and modulation of the tumor microenvironment. In particular, combining SGLT-2 inhibition with immune checkpoint blockade may enhance tumor control through metabolic-immunologic crosstalk. Preclinical evidence suggests that the SGLT-2 inhibitor canagliflozin may suppress tumor growth and potentially improve the efficacy of PD-1 blockade. Based on this rationale, this phase I trial investigates the safety and efficacy of canagliflozin combined with tislelizumab in patients with locally advanced or advanced solid tumors, evaluating its impact on progression-free survival, overall survival, objective response rate, and tumor microenvironment modulation. This study aims to explore a novel metabolic-immunotherapy strategy based on dual metabolic and immune regulation, potentially providing a new therapeutic option for patients with locally advanced or advanced solid tumors.

Dapagliflozin to Reduce the Decline in Renal Function in Patients Newly Diagnosed With Lupus Nephritis

Lupus nephritis is one of the most serious complications of lupus, an autoimmune disease in which the immune system mistakenly attacks the body's own tissues. This condition causes inflammation and damage to the kidneys and is a major cause of chronic kidney disease, especially in the Latin American population. In these patients, the disease often appears at a younger age, presents with more intense inflammation, and has a more aggressive course. Although treatments exist that help control the immune response and reduce kidney damage, a significant proportion of patients do not achieve sustained kidney recovery. As a result, protein loss in the urine persists, and kidney function continues to deteriorate over time. Given this situation, new therapeutic alternatives have emerged aimed at protecting kidney function. Among them is dapagliflozin, a medication that has shown benefits in various types of chronic kidney disease by helping to lower pressure within the kidneys, reduce inflammation, and limit the formation of scar tissue. However, there is still limited information on its effectiveness in people with active lupus nephritis. The objective of this study is to evaluate the efficacy and safety of dapagliflozin in preventing the progression of chronic kidney disease in patients with lupus nephritis. The results will generate scientific evidence to help improve renal protection strategies in this population. To this end, a phase II, open-label, controlled, randomized clinical trial will be conducted in adult patients newly diagnosed with lupus nephritis treated at the Nuevo Hospital Civil de Guadalajara "Dr. Juan I. Menchaca". Participants will be randomly assigned in a one-to-one ratio to two groups: one will receive standard treatment plus dapagliflozin (10 mg daily), and the other will receive only standard treatment. For three months, the amount of protein excreted in urine, renal function, and progression to chronic kidney disease will be evaluated. In addition, potential adverse effects, changes in lupus activity, and variables related to the prevention of cardiovascular, renal, and metabolic diseases will be recorded.

Assessment of Retinal-Angio Findings In Patients With Diabetes Type II Treated With Novel Antidiabetic Therapies

ARIADNE is a prospective observational cohort study of patients with type 2 diabetes mellitus (T2DM) treated with daily metformin and scheduled to initiate treatment with newer antidiabetic agents, such as sodium-glucose cotransporter 2 inhibitors (SGLT2 inhibitors) and glucagon-like peptide-1 receptor agonists (GLP-1RAs). These newer antidiabetic agents have demonstrated significant benefits in improving glycaemic control; however, some studies suggest that their rapid glucose-lowering effects may be associated with transient worsening or progression of retinal complications. The purpose of this study is to evaluate the efficacy and safety of newer antidiabetic agents on retinal vasculature and visual acuity, and to investigate how these changes are associated with alterations in markers of peripheral endothelial and cardiovascular function.

Effect of Empagliflozin on Inflammation

Empagliflozin is a drug given to lower glucose. It is used in the treatment of diabetes. However, it was shown to improve symptoms and survival of patients who are suffering from heart failure. The exact mechanism of this effect is currently not clearly understood. He hypothesize that empagliflozin has other properties than glucose lowering, that can explain its efficacy. One of these properties, is an anti-inflammatory effect. To document this, we are using a model of inflammation following percutaneous coronary scenting. We know that patients who get a stent will develop inflammation following stenting. This is documenting by a higher level of C-Reactive Protein 24 hours after the procedure. Patients who will participate in the study, will receive empagliflozin or a placebo tablet for 3 days prior to the revascularisation procedure. CRP and other inflammatory markers will be measured before intervention and 24 hours later. The goal is to demonstrate a lower rise in CRP following intervention in patients treated with empagliflozin vs. those who have received a placebo.

Efficacy and Safety of Dapagliflozin in Children With Proteinuria

This interventional study investigates the efficacy of dapagliflozin, a sodium-glucose co-transporter 2 (SGLT2) inhibitor, in pediatric patients with renal disease. The primary outcomes include changes in 24-hour proteinuria indexed to body surface area (mg/m²/day) and glomerular filtration rate (GFR) before and after dapagliflozin administration. By closely monitoring these parameters, the study aims to assess the renal protective potential of dapagliflozin in children and adolescents.

Effect of Sodium Glucose Co-transporter 2 Inhibitors on Left Atrial Remodeling in Diabetic Patients

To evaluate and follow-up left atrial volume, diastolic function by 2D echocardiography and left atrial strain parameters using speckle-tracking echocardiography in patients with type 2 diabetes mellitus (T2DM) before and after treatment with SGLT2 inhibitors