Clinical Trial: Association between HDL Cholesterol Efflux Capacity, HDL Subclass Fractionation, and Anti-VEGF Treatment Responsiveness with SGLT2 Inhibitors in Patients with Type 2 Diabetes and Diabetic Macular Edema: An Exploratory Study Using Stored Samples from the COMET Trial (Japan)

Tokyo, Aug. 11 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000062509) titled 'Association between HDL Cholesterol Efflux Capacity, HDL Subclass Fractionation, and Anti-VEGF Treatment Responsiveness with SGLT2 Inhibitors in Patients with Type 2 Diabetes and Diabetic Macular Edema: An Exploratory Study Using Stored Samples from the COMET Trial' on Aug. 7.

Study Type: Observational

Primary Sponsor: Institute - Chiba University

Condition: Condition - Type 2 Diabetes and Diabetic Macular Edema Classification by malignancy - Others Genomic information - NO

Objective: Narrative objectives1 - In a post-hoc analysis of the COMET trial (luseogliflozin vs. glimepiride in patients with type 2 diabetes and diabetic macular edema [DME] treated with intravitreal ranibizumab [1 + PRN]), we found that patients with higher baseline serum HDL-cholesterol (HDL-C) concentrations experienced a greater reduction in the number of anti-VEGF injections required with SGLT2 inhibitor treatment (treatment x HDL-C interaction hazard ratio: approximately 0.50).

In this study, by utilizing stored samples from the COMET trial, we directly measure HDL function (cholesterol efflux capacity) and subclass fractionation--rather than relying solely on HDL-C concentration--to elucidate whether the key driver modifying responsiveness to SGLT2 inhibitor therapy lies in its quantity (concentration) or its quality (function/subclasses). Basic objectives2 - Efficacy

Eligibility: Age-lower limit - 20 years-old = Gender - Male and Female Key inclusion criteria - Participants in the COMET trial Key exclusion criteria - Patients who withdrew consent via the opt-out procedure Target Size - 59

Recruitment Status: Recruitment status - No longer recruiting Date of protocol fixation - 2026 Year 06 Month 30 Day Date of IRB - 2026 Year 07 Month 30 Day Anticipated trial start date - 2026 Year 08 Month 08 Day Last follow-up date - 2026 Year 08 Month 08 Day

To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000071559

Disclaimer: Curated by HT Syndication.