UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000057674 |
|---|---|
| Receipt number | R000065901 |
| Scientific Title | Subgroup Analyses of the COMET trial: "Effectiveness and safety of Combination therapy of anti-VEGF treatment and SGLT2i in type 2 diabetes with diabetic Macular Edema, a parallel group comparison with the standard Treatment controlled by Glimepiride, multicenter, randomized, open-label trial" |
| Date of disclosure of the study information | 2025/04/25 |
| Last modified on | 2025/04/21 22:13:02 |
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Basic information
Public title
Subgroup Analyses of the COMET trial: "Effectiveness and safety of Combination therapy of anti-VEGF agent (Ranibizumab) and SGLT2i (LuseOgliflozin) in type 2 diabetes with diabetic Macular Edema, a parallel group comparison with the standard Treatment controlled by Glimepiride, multicenter, randomized, open-label trial"
Acronym
Subgroup Analyses of the COMET trial
Scientific Title
Subgroup Analyses of the COMET trial: "Effectiveness and safety of Combination therapy of anti-VEGF treatment and SGLT2i in type 2 diabetes with diabetic Macular Edema, a parallel group comparison with the standard Treatment controlled by Glimepiride, multicenter, randomized, open-label trial"
Scientific Title:Acronym
Subgroup Analyses of the COMET trial
Region
| Japan |
Condition
Condition
Diabetic macular edema in type 2 diabetes
Classification by specialty
| Endocrinology and Metabolism | Ophthalmology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study is to clarify the effects of SGLT2 inhibitors on DME and diabetic patients with DME by analyzing data obtained from the COMET trial from various angles not covered in the previous study.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The number of anti-VEGF injections up to 48 weeks after the start of the study
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
YES
Dynamic allocation
YES
Institution consideration
Institution is not considered as adjustment factor.
Blocking
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
SGLT2i group
The SGLT2 inhibitor (luceogliflozin 2.5 mg) will be taken orally for 48 weeks from the start of the study.
The anti-VEGF agents (ranibizumab 0.5 mg) will be injected intravitreously as an ophthalmic treatment. First, a single intraocular injection will be administered at the start of the study, and then follow-up observations will be conducted every four weeks. Additional injections will be administered as necessary according to the continued administration criteria and relapse administration criteria below.
Interventions/Control_2
SU group
The Sulfonyl urea (glimepiride 0.5 mg) will be taken orally for 48 weeks from the start of the study.
The anti-VEGF drug ranibizumab 0.5 mg will be injected intravitreously as an ophthalmic treatment. First, a single intraocular injection will be administered at the start of the study, and then follow-up observations will be conducted every four weeks. Additional injections will be administered as necessary according to the continued administration criteria and relapse administration criteria below.
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
The selection criteria for the COMET trial are as follows
Participants in the COMET trial
The inclusion criteria for the COMET trial are as follows
Patients who meet all the following criteria are eligible.
1 Type 2 diabetes patients aged 20 years or older and younger than 80 years at the time of obtaining consent.
2 Patients with diabetic macular edema extending to the fovea of the macula in the target eye. Corrected visual acuity 0.05 or higher.
3 Patients whose retinal thickness measured by OCT in the target eye at the time of screening is 350 micrometers or more. However, if both eyes meet the above criteria, the eye with the greater retinal thickness will be the target eye.
4 HbA1c at the time of screening 6.5 percents or more and less than 12.0 percents
5 BMI at the time of screening 18.5 kg/m2 or more
6 eGFR at the time of screening 30 mL/min1.73 m2 or more
7 Stable diabetes treatment for 8 weeks prior to screening.
8 Patients who have received a sufficient explanation of the study and have fully understood it, and who have given their own voluntary written consent to participate.
Key exclusion criteria
Patients enrolled in COMETtrial who meet any of the following criteria:
1) Those who have expressed their refusal to participate in this study through an information disclosure document
2) Those who are otherwise deemed inappropriate by the principal investigator
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | TOMOAKI |
| Middle name | |
| Last name | TATSUMI |
Organization
Chiba University Graduate School of Medicine
Division name
Department of Ophthalmology and Visual Science
Zip code
260-8670
Address
1-8-1, Inohana, Chuo-ku, Chiba, Chiba, Japan
TEL
0432227171
ttatsumi@chiba-u.jp
Public contact
Name of contact person
| 1st name | TOMOAKI |
| Middle name | |
| Last name | TATSUMI |
Organization
Chiba University Graduate School of Medicine
Division name
Department of Ophthalmology and Visual Science
Zip code
260-8670
Address
1-8-1, Inohana, Chuo-ku, Chiba, Chiba, Japan
TEL
0432227171
Homepage URL
ttatsumi@chiba-u.jp
Sponsor or person
Institute
Chiba University
Institute
Department
Personal name
Funding Source
Organization
TAISHO PHARMACEUTICAL HOLDINGS CO., LTD.
Organization
Division
Category of Funding Organization
Profit organization
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, Chiba, Japan
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
千葉大学
Other administrative information
Date of disclosure of the study information
| 2025 | Year | 04 | Month | 25 | 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
60
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
No longer recruiting
Date of protocol fixation
| 2024 | Year | 09 | Month | 01 | Day |
Date of IRB
| 2024 | Year | 09 | Month | 26 | Day |
Anticipated trial start date
| 2024 | Year | 09 | Month | 30 | Day |
Last follow-up date
| 2026 | Year | 09 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
| 2029 | Year | 09 | Month | 30 | Day |
Other
Other related information
Management information
Registered date
| 2025 | Year | 04 | Month | 21 | Day |
Last modified on
| 2025 | Year | 04 | Month | 21 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000065901
