UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000030548 |
|---|---|
| Receipt number | R000034855 |
| Scientific Title | Comparison of Dapagliflozin and Pioglitazone Effects on Nonalcoholic Fatty Liver Disease and Nonalcoholic Steatohepatitis in Patients With Type 2 Diabetes: A Randomized,Open-Label, Active-Controlled Trial |
| Date of disclosure of the study information | 2017/12/25 |
| Last modified on | 2018/09/21 09:49:21 |
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Basic information
Public title
Comparison of Dapagliflozin and Pioglitazone Effects on Nonalcoholic Fatty Liver Disease and Nonalcoholic Steatohepatitis in Patients With Type 2 Diabetes: A Randomized,Open-Label, Active-Controlled Trial
Acronym
Comparison of Dapagliflozin and Pioglitazone Effects on NAFLD and NASH in Patients With Type 2 Diabetes: A Randomized Trial
Scientific Title
Comparison of Dapagliflozin and Pioglitazone Effects on Nonalcoholic Fatty Liver Disease and Nonalcoholic Steatohepatitis in Patients With Type 2 Diabetes: A Randomized,Open-Label, Active-Controlled Trial
Scientific Title:Acronym
Comparison of Dapagliflozin and Pioglitazone Effects on NAFLD and NASH in Patients With Type 2 Diabetes: A Randomized Trial
Region
| Japan |
Condition
Condition
type 2 diabetes mellitus, NAFLD, NASH
Classification by specialty
| Hepato-biliary-pancreatic medicine | Endocrinology and Metabolism |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To compare the effects between dapagliflozin and pioglitazone on nonalcoholic fatty liver disease and nonalcoholic steatohepatitis in patients with type 2 diabetes
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
HbA1c, hepatic attenuation compared with spleen on CT scan imaging
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
Dapagliflozin 5 mg/day, 104 weeks
Interventions/Control_2
Pioglitazone 15-30 mg/day, 104 weeks
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
HbA1c= or > 6.5%
Key exclusion criteria
Patients with diabetes complications
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Satoshi Mochida |
Organization
Saitama Medical University
Division name
Department of gastroenterology and hepatology
Zip code
Address
38 Morohongo, Moroyamamachi
TEL
049-276-1111
smochida@saitama-med.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Nobuaki Nakayama |
Organization
Saitama Medical University
Division name
Department of gastroenterology and hepatology
Zip code
Address
38 Morohongo, Moroyamamachi
TEL
049-276-1111
Homepage URL
nobunaka@saitama-med.ac.jp
Sponsor or person
Institute
Saitama Medical University Hospital
Institute
Department
Personal name
Funding Source
Organization
Saitama Medical University
Organization
Division
Category of Funding Organization
Self funding
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
Other administrative information
Date of disclosure of the study information
| 2017 | Year | 12 | Month | 25 | 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
Completed
Date of protocol fixation
| 2015 | Year | 09 | Month | 14 | Day |
Date of IRB
Anticipated trial start date
| 2015 | Year | 09 | Month | 14 | 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 | 12 | Month | 24 | Day |
Last modified on
| 2018 | Year | 09 | Month | 21 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000034855
