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UMIN-CTR Clinical Trial |
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Name: | UMIN ID: |
Recruitment status | Enrolling by invitation |
Unique ID issued by UMIN | UMIN000028438 |
Receipt No. | R000032549 |
Scientific Title | Investigation of renal protective effects of SGLT2 inhibitor by using renal doppler ultrasonography |
Date of disclosure of the study information | 2017/07/29 |
Last modified on | 2020/07/31 |
Basic information | ||
Public title | Investigation of renal protective effects of SGLT2 inhibitor by using renal doppler ultrasonography | |
Acronym | INveStigation of renal Protective effects of SGLT2 Inhibitor by using REnal Doppler ultrasonography/INSPIRED Study | |
Scientific Title | Investigation of renal protective effects of SGLT2 inhibitor by using renal doppler ultrasonography | |
Scientific Title:Acronym | INveStigation of renal Protective effects of SGLT2 Inhibitor by using REnal Doppler ultrasonography/INSPIRED Study | |
Region |
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Condition | |||
Condition | Type 2 diabetes | ||
Classification by specialty |
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Classification by malignancy | Others | ||
Genomic information | NO |
Objectives | |
Narrative objectives1 | The purpose of this study is to elucidate renoprotective effects of SGLT2 inhibitor with doppler ultrasonography in patients with type 2 diabetes. |
Basic objectives2 | Safety,Efficacy |
Basic objectives -Others | |
Trial characteristics_1 | |
Trial characteristics_2 | |
Developmental phase |
Assessment | |
Primary outcomes | Change in Resistive Index: RI of renal doppler ultrasonography |
Key secondary outcomes | Group comparison of the following parameters before and after treatment
1)Physical examination Body weight, BMI, blood pressure and pulse rate 2)Hematology WBC, RBC, Hb, Ht, PLT 3)Biochemistry TC, HDL-C, TG, LDL-C, Cys-C, eGFRcyc, Cr, BUN, UA, Alb, Na, K, Cl, HbA1c, fasting blood glucose 4)plasma renin activity, plasma aldosterone concentration, erythropoietin 5)BNP 6)ketone body in venous blood 7)Urinalysis urine protein, urine Cr, urine sodium, urine potassium, urine NAG, urine alpha1-MG, urine L-FABP, urine albumin, urine glucose, urine specific gravity 8)Renal doppler ultrasonography Pulsatility Index: PI, Peak Systolic Velocity: PSV, End-Diastolic Velocity: EDV, Renal Aortic Ratio: RAR, Acceleration Time: AT 9)Abdominal ultrasonography liver 10)ABI/PWV 11)Adverse events |
Base | |
Study type | Interventional |
Study design | |
Basic design | Cross-over |
Randomization | Non-randomized |
Randomization unit | |
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 |
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Interventions/Control_1 | Patients, who take a 50mg of Sitagliptin at the timing of obtained agreement in this study, will be changed to take a 5mg of Dapagliflozin from Sitagliptin. The group of Sitagliptin or Dapagliflozin will be changed the pill to another one at 6 and 12 months, following to keep the medication in each group until 24 months. | |
Interventions/Control_2 | Patients, who take a 5mg of Dapagliflozin at the timing of obtained agreement in this study, will be changed to take a 50mg of Sitagliptin from Dapagliflozin. The group of Dapagliflozin or Sitagliptin will be changed the pill to another one at 6 and 12 months, following to keep the medication in each group until 24 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 |
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Age-upper limit |
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Gender | Male and Female | |||
Key inclusion criteria | 1)Type 2 diabetes
2)Patients with HbA1c 7% and below 3)Patients from 20 years old but less than 80 years old at obtaining consent 4)Patients who are treated with either Dapagliflozin 5mg or Sitagliptin 50mg 5)Patients whose HbA1c is within 1% during the last 3 months 6)Patients whose medicine did not change during the last 3 months |
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Key exclusion criteria | 1)Type 1 diabetes or suspicion of Type 1 diabetes
2)Clinical history of hypersensitivity to SGLT2 inhibitors 3)Severe ketosis, diabetic coma or precoma 4)Severe infectious disease, pre/post-surgery or serious trauma 5)End-stage renal failure under dialysis 6)Clinical history of brain infarction or ischemic cardiac disease 7)Pulmonary embolus or severe pulmonary function impediment 8)Pituitary or adrenal gland dysfunction 9)Status of dystrophy/starvation, irregular meal intake, dietary intake deficiency or hyposthenia 10)Excessive alcohol intake 11)Dehydrated patients including those with non-functioning GIT such as diarrhea, vomiting or malignancy 12)Complicated with malignancies 13)Pregnant/ possible pregnant, breastfeeding 14)Inappropriate patients for study participation judged by principal or clinical investigator 15)Dosing of GLP-1 receptor agonist 16)Combined use of Dapagliflozin and Sitagliptin 17)Dosing of SGLT2 inhibitors other than Dapagliflozin 18)Dosing of DPPIV inhibitors other than Sitagliptin |
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Target sample size | 60 |
Research contact person | |||||||
Name of lead principal investigator |
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Organization | Ogawa Red Cross Hospital | ||||||
Division name | Department of Internal Medicine | ||||||
Zip code | 3550397 | ||||||
Address | 1525 Ogawa, Ogawa-machi, Hiki-gun, Saitama Japan | ||||||
TEL | 0493-72-2333 | ||||||
sumi.jp@gmail.com |
Public contact | |||||||
Name of contact person |
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Organization | Ogawa Red Cross Hospital | ||||||
Division name | Department of Internal Medicine | ||||||
Zip code | 3550397 | ||||||
Address | 1525 Ogawa, Ogawa-machi, Hiki-gun, Saitama Japan | ||||||
TEL | 0493-72-2333 | ||||||
Homepage URL | |||||||
sumi.jp@gmail.com |
Sponsor | |
Institute | Ogawa Red Cross Hospital |
Institute | |
Department |
Funding Source | |
Organization | Ogawa Red Cross Hospital |
Organization | |
Division | |
Category of Funding Organization | Other |
Nationality of Funding Organization |
Other related organizations | |
Co-sponsor | |
Name of secondary funder(s) |
IRB Contact (For public release) | |
Organization | Ogawa Red Cross Hospital |
Address | 1525 Ogawa, Ogawa-machi, Hiki-gun, Saitama Japan |
Tel | 81493722333 |
sumi.jp@gmail.com |
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 | |
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Date of disclosure of the study information |
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Related information | |
URL releasing protocol | |
Publication of results | Unpublished |
Result | |
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Number of participants that the trial has enrolled | |
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Baseline Characteristics | |
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Plan to share IPD | |
IPD sharing Plan description |
Progress | |||||||
Recruitment status | Enrolling by invitation | ||||||
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Management information | |||||||
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Last modified on |
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Link to view the page | |
URL(English) | https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000032549 |
Research Plan | |
Registered date | File name |
Research case data specifications | |
Registered date | File name |
Research case data | |
Registered date | File name |