UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000026887 |
|---|---|
| Receipt number | R000030803 |
| Scientific Title | The effect of SGLT2 inhibitor on glomrular hyperfiltration in type 2 diabetes patients. |
| Date of disclosure of the study information | 2017/04/09 |
| Last modified on | 2019/04/15 14:15:02 |
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Basic information
Public title
The effect of SGLT2 inhibitor on glomrular hyperfiltration in type 2 diabetes patients.
Acronym
The effect of SGLT2 inhibitor on glomrular hyperfiltration
Scientific Title
The effect of SGLT2 inhibitor on glomrular hyperfiltration in type 2 diabetes patients.
Scientific Title:Acronym
The effect of SGLT2 inhibitor on glomrular hyperfiltration
Region
| Japan |
Condition
Condition
Type 2 diabetes mellitus
Classification by specialty
| Endocrinology and Metabolism |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To examine the effect of SGLT2 inhibitor on glomerular hyperfiltration in type 2 diabetes patients treated with DPP4 inhibitor.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
HbA1c
GFR(measure with inulin clearance)
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Oral administration of 2.5 mg luseogliflozin once a day, pre or post breakfast for 52 weeks
Interventions/Control_2
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1.HbA1c>=7.0%
2.Patients who have received treatment of type 2 diabetes mellitus(diet therapy, exercise therapy and so on)
3.eGFR>=100 ml/min/1.73m2
4.Patients who have received DPP4 inhibitor dose of them are stable over 8 weeks.
5.Age >= 20 years and Male and Female
6.Outpatients
7.Consent to study participation has been obtained in writing from the patient personally
Key exclusion criteria
1. The amount of change of eGFR between screening and initiation of study is more than 10ml/min/1.73m2
2. Patient with type 1 diabetes mellitus or with history of secondary diabetes mellitus
3. Patients with history of or concurrent complication that affect renal function(renal disease, nephrotic syndrome and so on)or patients with dialysis
4. Patients with the history of serious hepatic diseases.
5. Patients with history of myocardial infarction, congestive heart failure, unstable angina, cerebrovascular disease within 6 months prior to screening visit (confirmation of eligibility)
6. Patients with history of or concurrent complication that affect digestive function
7. Patients with the history of serious diabetic complications requiring treatment
8. Patients with history of malignant tumor
9. Patients with a history of drug allergies that interfere with participation in the clinical trial.
10. Patients suspected of alcohol or drug abuse.
11. Pregnant women, nursing mothers, or patients who do not agree to contraception during study period.
12. Patients with diabetes receiving SGLT2 inhibitor in the 8 weeks prior to screening period.
13. Patients who are judged as inappropriate by investigators on screening examination.
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | Katsushige |
| Middle name | |
| Last name | Abe |
Organization
Abe Diabetes Clinic
Division name
internal medicine
Zip code
870-0039
Address
16-13 nakakasuga,Oita
TEL
097-538-1633
rukonyan@ga2.so-net.ne.jp
Public contact
Name of contact person
| 1st name | Katsushige |
| Middle name | |
| Last name | Abe |
Organization
Abe Diabetes Clinic
Division name
internal medicine
Zip code
870-0039
Address
16-13 nakakasuga,Oita
TEL
097-538-1633
Homepage URL
rukonyan@ga2.so-net.ne.jp
Sponsor or person
Institute
Abe Diabetes Clinic
Institute
Department
Personal name
Funding Source
Organization
Taisho Toyama Pharmaceutical Co.Ltd
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
-
Address
-
Tel
-
-
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
内科阿部医院（大分）、白岩内科医院（大阪）
Other administrative information
Date of disclosure of the study information
| 2017 | Year | 04 | Month | 09 | 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
10
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
Completed
Date of protocol fixation
| 2017 | Year | 01 | Month | 25 | Day |
Date of IRB
| 2016 | Year | 12 | Month | 08 | Day |
Anticipated trial start date
| 2017 | Year | 04 | Month | 10 | Day |
Last follow-up date
| 2019 | Year | 01 | Month | 26 | 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 | 04 | Month | 06 | Day |
Last modified on
| 2019 | Year | 04 | Month | 15 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000030803
