Unique ID issued by UMIN | UMIN000020544 |
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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 |
Pleiotropic Effects and Safety of Sodium glucose co-transporter 2 inhibitor versus sulfonylurea in Patients With Type 2 Diabetes and Non-alcoholic Fatty Liver
SGLT2 Inhibitor versus Sulfonylurea on Type 2 Diabetes with NAFLD
Pleiotropic Effects and Safety of Sodium glucose co-transporter 2 inhibitor versus sulfonylurea in Patients With Type 2 Diabetes and Non-alcoholic Fatty Liver
SGLT2 Inhibitor versus Sulfonylurea on Type 2 Diabetes with NAFLD
Japan |
Type 2 Diabetes and Non-alcoholic Fatty Liver
Medicine in general | Endocrinology and Metabolism | Adult |
Others
YES
1. Which organ and how does SGLT2 inhibitor alter insulin sensitivity?
2. How does SGLT2 inhibitor increase glucagon levels and hepatic glucose production?
Safety,Efficacy
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.
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
Interventional
Parallel
Randomized
Individual
Open -but assessor(s) are blinded
Active
2
Treatment
Medicine |
SGLT2 inhibitor dosage (Tofogliflozin): a dose of 20mg once daily for 48 weeks.
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.
20 | years-old | <= |
Not applicable |
Male and Female
1. The biopsy consistent with the diagnosis of NAFLD
2. Type 2 diabetes, HbA1c >=7.0%
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.
40
1st name | |
Middle name | |
Last name | Toshinari Takamura |
Kanazawa University Graduate School of Medical Sciences
Comprehensive Metabology, Kanazawa University Graduate School of Medical Sciences
13-1 Takara-machi, Kanazawa, Ishikawa
076-265-2234
ttakamura@m-kanazawa.jp
1st name | |
Middle name | |
Last name | Yumie Takeshita |
Kanazawa university hospital
Department of Disease Control and Homeostasis
13-1 Takara-machi, Kanazawa, Ishikawa
076-265-2234
takeshita@m-kanazawa.jp
Kanazawa university hospital
Department of Disease Control and Homeostasis
Kowa Company, Ltd.
Profit organization
YES
NCT02649465
NCT02649465
金沢大学附属病院 恒常性制御学
2016 | Year | 01 | Month | 13 | Day |
Unpublished
Completed
2015 | Year | 11 | Month | 01 | Day |
2018 | Year | 02 | Month | 28 | Day |
2016 | Year | 01 | Month | 01 | Day |
2018 | Year | 03 | Month | 26 | Day |
We trasferred to other database (jRCTs0411800132)
2016 | Year | 01 | Month | 13 | Day |
2023 | Year | 10 | Month | 30 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000023720
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