UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000021291 |
|---|---|
| Receipt number | R000021576 |
| Scientific Title | The effectiveness of oral hypoglycemic agents in nonalcoholic fatty liver disease patients with type 2 diabetes mellitus. -Multiple comparison, Dapagliflozin, Pioglitazone vs Glimepiride- |
| Date of disclosure of the study information | 2016/03/02 |
| Last modified on | 2018/10/02 15:38:01 |
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Basic information
Public title
The effectiveness of oral hypoglycemic agents in nonalcoholic fatty liver disease patients with type 2 diabetes mellitus. -Multiple comparison, Dapagliflozin, Pioglitazone vs Glimepiride-
Acronym
The effectiveness of oral hypoglycemic agents in nonalcoholic fatty liver disease patients with type 2 diabetes mellitus. -Multiple comparison, Dapagliflozin, Pioglitazone vs Glimepiride-
Scientific Title
The effectiveness of oral hypoglycemic agents in nonalcoholic fatty liver disease patients with type 2 diabetes mellitus. -Multiple comparison, Dapagliflozin, Pioglitazone vs Glimepiride-
Scientific Title:Acronym
The effectiveness of oral hypoglycemic agents in nonalcoholic fatty liver disease patients with type 2 diabetes mellitus. -Multiple comparison, Dapagliflozin, Pioglitazone vs Glimepiride-
Region
| Japan |
Condition
Condition
Nonalcoholic fatty liver disease patients with type 2 diabetes
Classification by specialty
| Hepato-biliary-pancreatic medicine | Endocrinology and Metabolism |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The main condition of type 2 diabetes is impaired insulin secretion and insulin resistance and to maintain good glycemic control over time, the therapeutic strategies base on the pathology of diabetes is important. Therefore we compare the effect of the SGLT2 inhibitor which is a new type 2 diabetes therapeutic drug with sulfonylurea and thiazolidine. We consider an association between type 2 diabetes and NAFLD and compare the influence of these three kinds of diabetes therapeutic drugs on NAFLD. Besides, we examine the influence of these drugs on beta-cell function during an observation period. This study has possibility to bring important information on making a treatment strategy of type 2 diabetes.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Change of liver function and L/S ratio (CT) six months after the intervention
Key secondary outcomes
Change of body weight, visceral fat amount, fasting plasma glucose (FPG), insulin, triacylglycerol (TG), non-esterified fatty acid (NEFA), HDL-cholesterol, LDL-cholesterol, lipoprotein fractionation, adiponectin, hsCPR, TNF-alpha, MCP-, MDA, typIV collagen7S, P-III-P, M2BP, the fibrosis score (NAFLD fibrosis score, FIB-4 index, APRI, BARD score, BAAT score), proinsulin/S-CPR ratio
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
3
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Dapagliflozin 5mg Sig. 1 or 2 tab po once time a day
Interventions/Control_2
Pioglitazone 15mg Sig. 1 or 2 tab po once time a day
Interventions/Control_3
Glimepiride 0.5 or 1mg Sig. 1 or 3 tab po once or two times a day
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
Nonalcoholic fatty liver disease patients with type 2 diabetes mellitus who visit a hospital for treatment in the outpatient department of the facilities concerned.
Key exclusion criteria
A) Under 20 years old
B) Treatment with insulin
C) Treatment with SGLT-2 inhibitor, thiazolidinedione or sulfonylurea
D) Diabetic coma
E) Renal dysfunction (eGFR<45mL/min)
F) Cardiac failure
G) Viral hepatitis, alcoholic hepatitis, autoimmune hepatitis, liver cirrhosis
H) Infection
I) During treatment or treatment plan of malignant neoplasm
J) Autoimmune disease
K) Use of Steroid medicine and/or immunosuppressor
L) Pregnant, possibility of pregnancy, nursing or hope to become pregnant during the study period
M) In addition, when principal investigator or researcher deems inappropriate as a study subject
Target sample size
90
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Masashi Shimoda |
Organization
Kawasaki Medical SchoolKawasaki Medical School
Division name
Division of Diabetes, Endocrinology and Metabolism
Zip code
Address
Matushima577, Kurashiki, Okayama
TEL
086-462-1111
masashi-s@med.kawasaki-m.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Masashi Shimoda |
Organization
Kawasaki Medical SchoolKawasaki Medical School
Division name
Devision of Diabetes, Endocrinology and Metabolism
Zip code
Address
Matushima577, Kurashiki, Okayama
TEL
086-462-1111
Homepage URL
masashi-s@med.kawasaki-m.ac.jp
Sponsor or person
Institute
Kawasaki Medical SchoolKawasaki Medical School Devision of Diabetes, Endocrinology and Metabolism
Institute
Department
Personal name
Funding Source
Organization
none
Organization
Division
Category of Funding Organization
Non profit foundation
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
| 2016 | Year | 03 | Month | 02 | 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 | 10 | Month | 19 | Day |
Date of IRB
Anticipated trial start date
| 2015 | Year | 10 | Month | 19 | Day |
Last follow-up date
| 2017 | Year | 07 | Month | 19 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
| 2018 | Year | 05 | Month | 26 | Day |
Other
Other related information
Management information
Registered date
| 2016 | Year | 03 | Month | 02 | Day |
Last modified on
| 2018 | Year | 10 | Month | 02 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000021576
