UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Strategic Trial for the Prevention of Progression of Overt Diabetic Kidney Disease by GLP-1receptor agonists and SGLT2 inhibitors in Okinawa
Title of the study (Brief title)	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	Hiroshi SUNAGAWA
Organization	Sunagawa Medical Clinic
Division name	The Director
Address	600-5 Esu Uruma-city Okinawa
TEL	098-975-2555
Email	smc@siren.ocn.ne.jp

Public contact
Name of contact person	Kae SUNAGAWA
Organization	Sunagawa Medical Clinic
Division name	Center of Clinical Research Support
Address	600-5 Esu Uruma-city Okinawa
TEL	080-4422-1020
Homepage URL
Email	kae@sunagawamc.com

Sponsor
Institute	Sunagawa Medical Clinic
Institute
Department

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)

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

Progress
Recruitment status	Enrolling by invitation
Date of protocol fixation	2018 Year 01 Month 30 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000036126