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Recruitment status Terminated
Unique ID issued by UMIN UMIN000020544
Receipt No. R000023720
Scientific Title Pleiotropic Effects and Safety of Sodium glucose co-transporter 2 inhibitor versus sulfonylurea in Patients With Type 2 Diabetes and Non-alcoholic Fatty Liver
Date of disclosure of the study information 2016/01/13
Last modified on 2019/05/16

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Basic information
Public title Pleiotropic Effects and Safety of Sodium glucose co-transporter 2 inhibitor versus sulfonylurea in Patients With Type 2 Diabetes and Non-alcoholic Fatty Liver
Acronym SGLT2 Inhibitor versus Sulfonylurea on Type 2 Diabetes with NAFLD
Scientific Title Pleiotropic Effects and Safety of Sodium glucose co-transporter 2 inhibitor versus sulfonylurea in Patients With Type 2 Diabetes and Non-alcoholic Fatty Liver
Scientific Title:Acronym SGLT2 Inhibitor versus Sulfonylurea on Type 2 Diabetes with NAFLD
Region
Japan

Condition
Condition Type 2 Diabetes and Non-alcoholic Fatty Liver
Classification by specialty
Medicine in general Endocrinology and Metabolism Adult
Classification by malignancy Others
Genomic information YES

Objectives
Narrative objectives1 1. Which organ and how does SGLT2 inhibitor alter insulin sensitivity?
2. How does SGLT2 inhibitor increase glucagon levels and hepatic glucose production?
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes 1. The improvement in histologic features of NAFLD, as assessed with a composite of standardized scores for steatosis, lobular inflammation, hepatocellular ballooning, and fibrosis. Disease activity is assessed with the nonalcoholic fatty liver disease activity score, which is based on a standardized grading system for steatosis (on a scale of 0 to 3), lobular inflammation (on a scale of 0 to 3), and hepatocellular ballooning (on a scale of 0 to 2), with higher scores indicating increasing severity.
Key secondary outcomes Change from baseline in liver enzymes
Change from baseline in body composition
Change from baseline in fasting plasma glucose level and glucose metabolism assessed with arginine tolerance test
Changes from baseline in organ-specific insulin sensitivity and glucagon response during a euglycemic hyperinsulinemic clamp study
Change from baseline in lipid profile
Change from baseline in renal function and electrolyte balances
Change from baseline in oxidative stress
Change from baseline in cytokine (TNF-alpha, leptin, adiponectin) levels
Change from baseline in hepatokine (Selenoprotein P, LECT2) levels
Change from baseline in organ-specific fat accumulation
Change from baseline in oxidative and non-oxidative glucose disposal
Change from baseline in respiratory quotients
Change from baseline in energy expenditure
Change from baseline in autonomic nerve function. This is performed by power-spectrum analyses of heart rate variability
Changes from baseline in minerals and bone metabolism
Changes from baseline in endothelial functions
Changes from baseline in fatty acids profiles
Factors associated with the changes in autonomic nerve function, organ-specific fat accumulation, and glucagon response.
Changes from baseline in gene expression profiles in the liver and blood cells
Changes from baseline in microRNAs and exosome contents
Epigenomic changes from baseline in genes of the liver and blood cells

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Open -but assessor(s) are 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 SGLT2 inhibitor dosage (Tofogliflozin): a dose of 20mg once daily for 48 weeks.
Interventions/Control_2 dosing from 0.5 mg for initial 4 weeks. Then, if there is no adverse effect or no improvement of glucose metabolism, glimepiride is escalated to 6 mg once daily.
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. The biopsy consistent with the diagnosis of NAFLD
2. Type 2 diabetes, HbA1c >=7.0%
Key exclusion criteria Hepatic virus infections, autoimmune hepatitis, primary biliary cirrhosis, sclerosing cholangitis, haemochromatosis, antitrypsin deficiency, Wilsons disease, history of parenteral nutrition and use of drugs known to induce steatosis or hepatic injury caused by substance abuse and or the current or past consumption of more than 20 g of alcohol daily
Hypersensitivity to or contraindication of glimepiride and tofogliflozin
None type 2 diabetes
Poorly controlled diabetes
Repeated episodes of unexplained hypoglycemia
Concomitant infection or planned surgery
Poorly controlled hypertension
Severe retinopathy
Malignancy on an active therapeutic regimen or malignancy without complete remission or cure
Severe health problems not suitable for the study
Pregnant or lactating women
Inability to participate in the study as assessed by the investigators.
Target sample size 40

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Toshinari Takamura
Organization Kanazawa University Graduate School of Medical Sciences
Division name Comprehensive Metabology, Kanazawa University Graduate School of Medical Sciences
Zip code
Address 13-1 Takara-machi, Kanazawa, Ishikawa
TEL 076-265-2234
Email ttakamura@m-kanazawa.jp

Public contact
Name of contact person
1st name
Middle name
Last name Yumie Takeshita
Organization Kanazawa university hospital
Division name Department of Disease Control and Homeostasis
Zip code
Address 13-1 Takara-machi, Kanazawa, Ishikawa
TEL 076-265-2234
Homepage URL
Email takeshita@m-kanazawa.jp

Sponsor
Institute Kanazawa university hospital
Department of Disease Control and Homeostasis
Institute
Department

Funding Source
Organization Kowa Company, 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
Email

Secondary IDs
Secondary IDs YES
Study ID_1 NCT02649465
Org. issuing International ID_1 NCT02649465
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions 金沢大学附属病院 恒常性制御学

Other administrative information
Date of disclosure of the study information
2016 Year 01 Month 13 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 Terminated
Date of protocol fixation
2015 Year 11 Month 01 Day
Date of IRB
2018 Year 02 Month 28 Day
Anticipated trial start date
2016 Year 01 Month 01 Day
Last follow-up date
2018 Year 03 Month 26 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information We trasferred to other database (jRCTs0411800132)

Management information
Registered date
2016 Year 01 Month 13 Day
Last modified on
2019 Year 05 Month 16 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000023720

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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