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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 2017/07/29

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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
Middle name
Last name Takashi Sumita
Organization Ogawa Red Cross Hospital
Division name Department of Internal Medicine
Zip code
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
Middle name
Last name Takashi Sumita
Organization Ogawa Red Cross Hospital
Division name Department of Internal Medicine
Zip code
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
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
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
Anticipated trial start date
2017 Year 06 Month 20 Day
Last follow-up date
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
2017 Year 07 Month 29 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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