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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000031651
Receipt No. 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

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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
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)

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
URL(English) https://upload.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


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