UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000020544
Receipt number 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 2023/10/30 13:35:09

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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 or person

Institute

Kanazawa university hospital
Department of Disease Control and Homeostasis

Institute

Department

Personal name



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

Completed

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

2023 Year 10 Month 30 Day



Link to view the page

Value
https://center6.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