UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000062509 |
|---|---|
| Receipt number | R000071559 |
| Scientific Title | 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 |
| Date of disclosure of the study information | 2026/08/07 |
| Last modified on | 2026/08/07 13:57:09 |
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Basic information
Public title
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
Acronym
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
Scientific Title
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
Scientific Title:Acronym
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
Region
| Japan |
Condition
Condition
Type 2 Diabetes and Diabetic Macular Edema
Classification by specialty
| Endocrinology and Metabolism | Ophthalmology |
Classification by malignancy
Others
Genomic information
NO
Objectives
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
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Interaction (effect modification) between baseline (Week 0) HDL functional parameters (CEC/CUC) and HDL subclass fractionation, and the cumulative number of anti-VEGF injections up to Week 48 under SGLT2 inhibitor therapy
Key secondary outcomes
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 20 | years-old | <= |
Age-upper limit
| 80 | 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 sample size
59
Research contact person
Name of lead principal investigator
| 1st name | Ryoichi |
| Middle name | |
| Last name | Ishibashi |
Organization
Chiba University Graduate School of Medicine
Division name
Department of Endocrinology and Gerontology
Zip code
260-8677
Address
1-8-1 Inohana, Chuo-ku, Chiba
TEL
043-222-7171
ishibashi-cib@umin.net
Public contact
Name of contact person
| 1st name | Ryoichi |
| Middle name | |
| Last name | Ishibashi |
Organization
Chiba University Graduate School of Medicine
Division name
Department of Endocrinology and Gerontology
Zip code
260-8677
Address
1-8-1 Inohana, Chuo-ku, Chiba
TEL
043-222-7171
Homepage URL
ishibashi-cib@umin.net
Sponsor or person
Institute
Chiba University
Institute
Department
Personal name
Funding Source
Organization
not yet fixed
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Chiba University Hospital Observational Research Ethics Committee
Address
1-8-1 Inohana, Chuo-ku, Chiba
Tel
043-222-7171
hsp-kansaturinri@chiba-u.jp
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2026 | Year | 08 | Month | 07 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Preinitiation
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 |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
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).
Management information
Registered date
| 2026 | Year | 08 | Month | 07 | Day |
Last modified on
| 2026 | Year | 08 | Month | 07 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000071559
