Unique ID issued by UMIN | UMIN000031651 |
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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 |
Strategic Trial for the Prevention of Progression of Overt Diabetic Kidney Disease by GLP-1receptor agonists and SGLT2 inhibitors in Okinawa
STOPPER in OKINAWA
Strategic Trial for the Prevention of Progression of Overt Diabetic Kidney Disease by GLP-1receptor agonists and SGLT2 inhibitors in Okinawa
STOPPER in OKINAWA
Japan |
Diabetice
Medicine in general | Endocrinology and Metabolism | Nephrology |
Others
NO
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.
Efficacy
Confirmatory
Pragmatic
Not applicable
After 12 months starting administration of decrease rate of estimated glomerular filtration rate (%DeGFR)
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
Interventional
Parallel
Randomized
Cluster
Open -no one is blinded
Active
YES
YES
Institution is not considered as adjustment factor.
YES
Central registration
2
Treatment
Medicine |
Daily subcutaneous injection of liraglutide 0.6 to 0.9 mg/day for 1 year
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.
20 | years-old | <= |
80 | years-old | > |
Male and Female
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
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
80
1st name | |
Middle name | |
Last name | Hiroshi SUNAGAWA |
Sunagawa Medical Clinic
The Director
600-5 Esu Uruma-city Okinawa
098-975-2555
smc@siren.ocn.ne.jp
1st name | |
Middle name | |
Last name | Kae SUNAGAWA |
Sunagawa Medical Clinic
Center of Clinical Research Support
600-5 Esu Uruma-city Okinawa
080-4422-1020
kae@sunagawamc.com
Sunagawa Medical Clinic
None
Self funding
NO
2018 | Year | 04 | Month | 02 | Day |
Unpublished
Enrolling by invitation
2018 | Year | 01 | Month | 30 | Day |
2018 | Year | 06 | Month | 01 | Day |
2020 | Year | 06 | Month | 30 | Day |
2020 | Year | 08 | Month | 31 | Day |
2020 | Year | 09 | Month | 30 | Day |
2020 | Year | 10 | Month | 31 | Day |
2018 | Year | 03 | Month | 09 | Day |
2018 | Year | 09 | Month | 08 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000036126
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