UMIN-CTR Clinical Trial

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	Japan

Condition
Condition	Type 2 diabetes
Classification by specialty	Medicine in general Endocrinology and Metabolism
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	Medicine
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	20 years-old <=
Age-upper limit	80 years-old >
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
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
Target sample size	60

Research contact person
Name of lead principal investigator	1st name Takashi Middle name Last name Sumita
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
Email	sumi.jp@gmail.com

Public contact
Name of contact person	1st name Takashi Middle name Last name Sumita
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
Email	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
Email	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
Institutions

Other administrative information
Date of disclosure of the study information	2017 Year 07 Month 29 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	2017 Year 06 Month 16 Day
Date of IRB	2017 Year 06 Month 16 Day
Anticipated trial start date	2017 Year 06 Month 20 Day
Last follow-up date	2023 Year 07 Month 30 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2017 Year 07 Month 29 Day
Last modified on	2020 Year 07 Month 31 Day

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

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