UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000033961
Receipt number 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 2024/03/26 18:25:43

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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 Kotaro
Middle name
Last name Yokote

Organization

Chiba University Hospital

Division name

Department of Diabetes, Metabolism & Endocrinology

Zip code

260-8677

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 Hiroki
Middle name
Last name Takayama

Organization

Soiken Inc.

Division name

Clinical Study Support Division

Zip code

101-0052

Address

NBF Ogawamachi Building 4F, 1-3-1 Ogawamachi, Kanda, Chiyoda-ku, Tokyo

TEL

03-3295-1350

Homepage URL


Email

takayama@soiken.com


Sponsor or person

Institute

Chiba University

Institute

Department

Personal name



Funding Source

Organization

Taisho 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

Clinical Research Ethics Committee of the Chiba University Hospital

Address

1-8-1 Inohana, Chuo-ku, Chiba-shi, Chiba 260-8670, JAPAN

Tel

043-222-7171

Email

prc-jim@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

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

Completed

Date of protocol fixation

2018 Year 08 Month 03 Day

Date of IRB

2019 Year 01 Month 23 Day

Anticipated trial start date

2019 Year 03 Month 18 Day

Last follow-up date

2024 Year 07 Month 31 Day

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

2024 Year 03 Month 26 Day



Link to view the page

Value
https://center6.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