UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000031651
Receipt number R000036126
Scientific Title Strategic Trial for the Prevention of Progression of Overt Diabetic Kidney Disease by GLP-1receptor agonists and SGLT2 inhibitors in Okinawa
Date of disclosure of the study information 2018/04/02
Last modified on 2018/09/08 14:41:53

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Basic information

Public title

Strategic Trial for the Prevention of Progression of Overt Diabetic Kidney Disease by GLP-1receptor agonists and SGLT2 inhibitors in Okinawa

Acronym

STOPPER in OKINAWA

Scientific Title

Strategic Trial for the Prevention of Progression of Overt Diabetic Kidney Disease by GLP-1receptor agonists and SGLT2 inhibitors in Okinawa

Scientific Title:Acronym

STOPPER in OKINAWA

Region

Japan


Condition

Condition

Diabetice

Classification by specialty

Medicine in general Endocrinology and Metabolism Nephrology

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

Type 2 diabetic patients with diabetic kidney disease (DKD) are targeted. The influence on the development of DKD based on the rate of decrease in estimated glomerular filtration rate (%DeGFR,eGFR=mL/min/1.73 m(2)) as an index was evaluated by the combined administration of liraglutide and empagliflozin compared with liraglutide alone, we will prove that the rate can be suppressed.

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1

Confirmatory

Trial characteristics_2

Pragmatic

Developmental phase

Not applicable


Assessment

Primary outcomes

After 12 months starting administration of decrease rate of estimated glomerular filtration rate (%DeGFR)

Key secondary outcomes

After 12 months starting administration of
0.Decrease amount of estimated glomerular filtration rate (DeGFR)
1.Changes in quantitative determination of urinary albumin
2.Changes in urine protein quantification
3.Change in HbA1c value
4.Change in weight
5.Frequency of hypoglycemia
6.Cardiovascular events: acute myocardial infarction, cerebral infarction (excluding lacunar infarction)
7.Renal event: Introduction of dialysis
8.Total death
9.Change in LDL-C value
10.Change in Non-HDL value
11.Change in TG value
12.Change in HDL-C value
13.Change in dynamic quantity evaluation
14.Change in intestinal flora
15.Changes in body composition


Base

Study type

Interventional


Study design

Basic design

Parallel

Randomization

Randomized

Randomization unit

Cluster

Blinding

Open -no one is blinded

Control

Active

Stratification

YES

Dynamic allocation

YES

Institution consideration

Institution is not considered as adjustment factor.

Blocking

YES

Concealment

Central registration


Intervention

No. of arms

2

Purpose of intervention

Treatment

Type of intervention

Medicine

Interventions/Control_1

Daily subcutaneous injection of liraglutide 0.6 to 0.9 mg/day for 1 year

Interventions/Control_2

Daily subcutaneous injection of liraglutide 0.6 to 0.9 mg/day for 26 weeks, and administration of 10 mg of empargliflozin from the 27th week. The combination is continued for 6 months.

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

1. Have been in Sunagawa Medical Clinic more than 1 year.
2. Patients with Type 2 diabetes mellitus with overt emergent diabetic nephropathy (3rd and 4th stage).
3. Patients with a urine protein/Cr ratio of 500 mg/gCr or more.
4. Reduced salt guidance (6g/day).
5. Urinary protein/Cr ratio is 500mg/gCr more than twice.
6. RAS inhibitor administration for 6 months or more than twice.
7. At registration, eGFR is more than 20 ml/min/1.73m (2)
8. HbA1c is less than 10% at registration

Key exclusion criteria

1. Diabetes with complications requiring hospitalization such as diabetic ketoacidosis
2. Severe heart failure, severe arrhythmia, angina pectoris, myocardial infarction, stroke developed within 6 months before the start of the study
3. Pregnant women or patients who may be pregnant and breast-feeding patients
4. Ingestion of SGLT2 inhibitor
5. Have a history of having serious side effects with GLP-1 receptor agonist and SGLT2 inhibitor
6. Patients who had positive urinary occult blood test at least twice within 6 months
7. Patients with malignant tumor complications
8. Patients complicated of mental illness without self-determination ability
9. Other patients judged inappropriate by the attending physician

Target sample size

80


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Hiroshi SUNAGAWA

Organization

Sunagawa Medical Clinic

Division name

The Director

Zip code


Address

600-5 Esu Uruma-city Okinawa

TEL

098-975-2555

Email

smc@siren.ocn.ne.jp


Public contact

Name of contact person

1st name
Middle name
Last name Kae SUNAGAWA

Organization

Sunagawa Medical Clinic

Division name

Center of Clinical Research Support

Zip code


Address

600-5 Esu Uruma-city Okinawa

TEL

080-4422-1020

Homepage URL


Email

kae@sunagawamc.com


Sponsor or person

Institute

Sunagawa Medical Clinic

Institute

Department

Personal name



Funding Source

Organization

None

Organization

Division

Category of Funding Organization

Self funding

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 04 Month 02 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 01 Month 30 Day

Date of IRB


Anticipated trial start date

2018 Year 06 Month 01 Day

Last follow-up date

2020 Year 06 Month 30 Day

Date of closure to data entry

2020 Year 08 Month 31 Day

Date trial data considered complete

2020 Year 09 Month 30 Day

Date analysis concluded

2020 Year 10 Month 31 Day


Other

Other related information



Management information

Registered date

2018 Year 03 Month 09 Day

Last modified on

2018 Year 09 Month 08 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000036126


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name