UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000015727 |
|---|---|
| Receipt number | R000018010 |
| Scientific Title | Randomized, controlled trial of the clinical effect of selecrive SGLT2 blocker, ipragliflozin, and DPP-4 blocker in type 2 diabetic patients with NAFLD/NASH.- multicenter study - |
| Date of disclosure of the study information | 2014/11/24 |
| Last modified on | 2020/01/12 15:28:22 |
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Basic information
Public title
Randomized, controlled trial of the clinical effect of selecrive SGLT2 blocker, ipragliflozin, and DPP-4 blocker in type 2 diabetic patients with NAFLD/NASH.- multicenter study -
Acronym
Randomized, controlled trial of ipragliflozin and DPP-4 blocker in type 2 diabetic patients with NAFLD/NASH.
Scientific Title
Randomized, controlled trial of the clinical effect of selecrive SGLT2 blocker, ipragliflozin, and DPP-4 blocker in type 2 diabetic patients with NAFLD/NASH.- multicenter study -
Scientific Title:Acronym
Randomized, controlled trial of ipragliflozin and DPP-4 blocker in type 2 diabetic patients with NAFLD/NASH.
Region
| Japan |
Condition
Condition
type 2 diabetic patients with NAFLD/NASH
Classification by specialty
| Hepato-biliary-pancreatic medicine | Endocrinology and Metabolism |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Examination of whether glycemic control is improved by ipragliflozin or DPP-4 blocker in type 2 diabetic patients with NAFLD/NASH.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Rate of patients decreasing of HbA1c>0.5% and not gaining weight gain 72 weeks after administration.
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
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
dietand ergotherapy and or (alpa-GI, Met) and sugra.
Interventions/Control_2
diet and ergotherapy and/or (alpa-GI,Met) +DPP-4 blocker.
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.Diet and exercise therapy plus or minus oral diabetes agent therapy, for example a-GI or metformin, for more than 12 weeks. The condition is the following HbA1c is more than 6.5
2.Patients with NASH or NAFLD diagnosed by using the guideline defined by JGH
3.Age is no fewer than 80, nor more than 20
4.Sex is female or male
5.Consenting patients
Key exclusion criteria
1.Ppatients with diabetes
2.Patients with past history of ovascular lesion or stroke
3.Patients with past history of allergy
4.Patients with the necessity of IRI therapy
5.Patients with past history of liver disorder or renal dysfunction
6.Inadequacy of usingig this therapy
Target sample size
128
Research contact person
Name of lead principal investigator
| 1st name | Keizo |
| Middle name | |
| Last name | Anzai |
Organization
Saga University
Division name
internal Medicine
Zip code
8498501
Address
5-1-1 Nabeshima, Saga
TEL
0952-34-2362
akeizo0479@gmail.com
Public contact
Name of contact person
| 1st name | Hirokazu |
| Middle name | |
| Last name | Takahashi |
Organization
Saga University
Division name
internal Medicine
Zip code
8498501
Address
5-1-1 Nabeshima, Saga
TEL
0952-.34-2362
Homepage URL
takahas2@cc.saga-u.ac.jp
Sponsor or person
Institute
Saga University
Institute
Department
Personal name
Funding Source
Organization
Astellas Pharma Inc.
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
clinical research center, saga university hospital
Address
5-1-1 Nabesima, Saga
Tel
0952343400
@
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
| 2014 | Year | 11 | Month | 24 | 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
55
Results
Results date posted
Results Delayed
| Delay expected |
Results Delay Reason
This study corresponded to Specified Clinical Research and result will be open on jRCT.
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
| 2014 | Year | 08 | Month | 13 | Day |
Date of IRB
| 2014 | Year | 08 | Month | 13 | Day |
Anticipated trial start date
| 2014 | Year | 10 | Month | 01 | Day |
Last follow-up date
| 2019 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
| 2019 | Year | 12 | Month | 31 | Day |
Date analysis concluded
Other
Other related information
This study corresponded to Specified Clinical Research and detailed information was registered with jRCT.
Management information
Registered date
| 2014 | Year | 11 | Month | 20 | Day |
Last modified on
| 2020 | Year | 01 | Month | 12 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000018010
