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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000033961
Receipt No. R000038737
Scientific Title Effectiveness and safety of Combination therapy of Ranibizumab and 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. (COMET Trial)
Date of disclosure of the study information 2018/08/30
Last modified on 2019/03/04

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Basic information
Public title Effectiveness and safety of Combination therapy of Ranibizumab and 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. (COMET Trial)
Acronym Effectiveness and safety of Combination therapy of Ranibizumab and 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. (COMET Trial)
Scientific Title Effectiveness and safety of Combination therapy of Ranibizumab and 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. (COMET Trial)
Scientific Title:Acronym Effectiveness and safety of Combination therapy of Ranibizumab and 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. (COMET Trial)
Region
Japan

Condition
Condition diabetic macular edema, diabetes mellitus
Classification by specialty
Endocrinology and Metabolism Ophthalmology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To assess the efficacy of SGLT2 inhibitor compared with glimepiride on glycemic control and improvement of diabetic macular edema in combination with anti-VEGF intravitreal injection therapy by randomized controlled trial
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Intergroup difference in number of anti-VEGF intravitreal injection to the study eye from baseline to week 48
Key secondary outcomes [Efficacy secondary endpoints]
(1) Change and percent change of following items from baseline to each observation point (every 4 weeks up to week 48) and intergroup difference of them.
1. Proportion of patients who require additional anti-VEGF intravitreal injections to the study eye after the initial anti-VEGF intravitreal injection
2. Proportion of patients who do not require additional anti-VEGF intravitreal injections to the study eye between 4 weeks after the initial anti-VEGF intravitreal injection to each observation point (every 4 weeks up to week 48)
3. Number of retinal microaneurysm photocoagulation (MAPC) to retinal arteriolar macroaneurysm of the study eye from baseline to week 48
4. Central retina thickness of the study eye at each observation point measured by optical coherence tomography (OCT)
5. Corrected visual acuity of the study eye at each observation point converted to logarithm of minimam angle of resolution (logMAR)
6. Presence or absence of hemorrhage at macular area or hard exudate in the study eye at each observation point measured by opthalmoscopy
7. Presence or absence of active leakage from blood vessels surrounding the macula area of the study eye measured by fluorescein angiography
8. Morphology of acular edema and visual acuity, central retina thickness, number of injections of the study eye at each observation point
9. Body weight, body mass index (BMI), blood pressure, pulse, HbA1c, plasma glucose, eGFR and Hct

<Due to the word limit in the UMIN-CTR, other secondary and exploratory endpoints are described in the attached protocol>

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Open -no one is blinded
Control Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 SGLT2 inhibitor (luseogliflozin) treatment group
Interventions/Control_2 Control (glimepiride treatment) group
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
75 years-old >
Gender Male and Female
Key inclusion criteria Patients who meet all of the following criteria are included in this study.
1) Patients with type 2 diabetes mellitus who are aged of 20 years or older and younger than 75 years when giving their consent
2) patients with diabetic macular edema which affects fovea centralis of macula lutea, and with corrected visual acuity of 0.05 or higher
3) patients with retina thickness of study eye measured by OCT is 350 micrometer or more at the screening test. If the retina thickness of both eyes are 350 micrometer of more, the eye with thicker retina is defined as the study eye.
4) patients with HbA1c of 6.5% or higher and less than 10.0% at the screening test
5) patients with BMI of 18.5 kg/m2 or higher at the screening test
6) patients with eGFR of 30 mL/min/1.73m2 or higher at the screening test
7) patients in whom treatment of diabetes mellitus have not been changed in 8 weeks before the screening test
8) patients who provide written consent form to participate in this study after full explanation of the study
Key exclusion criteria Patients who fall into any of the following criteria are excluded from participating in the study.
<internal medicine>
1) patients with type 1 diabetes mellitus
2) patients with history of hypersensitivity against SGLT2 inhibitor or glimepiride
3) patients with history of coma or precoma due to the diabetes mellitus or hypoglycemia in the 24 weeks before the screening test
4) Patients with severe infections, before or after surgery, or severe trauma which require insulin treatment
5) Patients with severe renal dysfunction (eGFR < 30mL/ min/1.73m2), or patients who undergo dialysis (including peritoneal dialysis)
6) Female patients who are pregnant, possibly pregnant, or planned to be pregnant or breast feeding
7) Patients with urinary tract infection or dehydration, or patients who are prone to urinary tract infection or dehydration
8) Patients with positive urinary ketone body (urine qualitative of 2+ or higher)
9) Patients with history of leg amputation due to leg gangrene
10) Patients with history of bone fracture due to osteoporosis
and others

<ophthalmology>
16) patients with history of retina vitreal surgery or scleral buckling
17) Patients with history of filtration surgery to the study eye for glaucoma treatment, or patients who are expected to require the filtration surgery in future
18) Patients with active proliferative diabetic retinopathy in the study eye
19) Patients with history of idiopathic or autoimmune uveitis in the study eye
20) Patients with vitreomacular traction syndrome or epi-retinal membrane in the study eye measured by slit lamp microscope or OCT, which affect the central visual acuity
and others

<common>
35) Patients with other conditions that the investigator/researcher thinks inappropriate for the study

<Due to the word limit in the UMIN-CTR, other exclusion criteria are described in the attached protocol>
Target sample size 60

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Shuichi Yamamoto / Kotaro Yokote
Organization Chiba University
Division name Graduate School of Medicine
Zip code
Address 1-8-1 Inohana, Chuo-ku, Chiba-shi, Chiba 260-8670, JAPAN
TEL 043-222-7171
Email kyokote@faculty.chiba-u.jp

Public contact
Name of contact person
1st name
Middle name
Last name Hiroki Takayama
Organization Soiken Inc.
Division name Clinical Study Support Division
Zip code
Address NBF Ogawamachi Building 4F, 1-3-1 Ogawamachi, Kanda, Chiyoda-ku, Tokyo
TEL 03-3295-1350
Homepage URL
Email takayama@soiken.com

Sponsor
Institute Chiba University
Institute
Department

Funding Source
Organization Taisho Toyama Pharmaceutical 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
Address
Tel
Email

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
2018 Year 08 Month 30 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 Enrolling by invitation
Date of protocol fixation
2018 Year 08 Month 03 Day
Date of IRB
Anticipated trial start date
2018 Year 08 Month 30 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2018 Year 08 Month 30 Day
Last modified on
2019 Year 03 Month 04 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000038737

Research Plan
Registered date File name
2018/09/04 COMET_Trial_protocol_UMIN-CTR_English.pdf

Research case data specifications
Registered date File name

Research case data
Registered date File name


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