UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000028438 |
|---|---|
| Receipt number | 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 13:46:29 |
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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 | 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
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
sumi.jp@gmail.com
Sponsor or person
Institute
Ogawa Red Cross Hospital
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000032549
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