UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Study to evaluate release of glucose toxicity associated with SGLT2 inhibitors administered in patients with metabolic syndrome in type 2 diabetes
Title of the study (Brief title)	Study to evaluate release of glucose toxicity associated with SGLT2 inhibitors administered in patients with metabolic syndrome in type 2 diabetes
Region	Japan

Condition
Condition	Type 2 diabetes
Classification by specialty	Medicine in general Endocrinology and Metabolism
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To clarify the effect of SGLT2 inhibitors on glucose toxicity in patients with metabolic syndrome in type 2 diabetes
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	1.Blood glucose-related: HbA1c, fasting glucose, glucagon 2.Insulin secretion-related: fasting insulin, plasma glucose after glucose tolerance test, fasting blood CPR, CPI 3.Insulin resistance: Matsuda Index 4.Metabolic syndrome-related: Abdominal circumference, neutral fat, HDL cholesterol, blood pressure 5.Oxidative stress-related: high-sensitivity CRP, adiponectin
Key secondary outcomes

Base
Study type	Interventional

Study design
Basic design	Single arm
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	1
Purpose of intervention	Treatment
Type of intervention	Medicine
Interventions/Control_1	SGLT2 inhibitors
Interventions/Control_2
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)Patients with type 2 diabetes (2)Patients satisfied with the criteria of metabolic syndrome (3)Patients aged >= 20 years (4)Patients who have competence to understand the study and agree with the written informed consent (5)Patients who have not taken SGLT2 inhibitors in the last 4 weeks until the second visit
Key exclusion criteria	(1)Patients with type 1 diabetes (2)Patients with a history of severe ketosis, diabetic coma, or diabetic pre-coma within 6 months prior to the start of study (3)Patients with severe infection or serious trauma, or in a pre- or post-operative phase (4)Patients with a history of hypersensitivity to the components of the study drug (5)Patients with severe renal dysfunction (eGFR <30 mL/min/1.73 m2) or end-stage renal failure undergoing dialysis (6)Patients with serious hepatic dysfunction (7)Pregnant or lactating women, or those expecting to become pregnant during the study period (8)Patients judged inadequate to enroll in the study at the discretion of principal investigator or subinvestigator
Target sample size	30

Research contact person
Name of lead principal investigator	Yoshimitsu Yamasaki
Organization	Medical Corporation KYOSOKAI AMC Nishi Umeda Clinic
Division name	Internal Medicine
Address	Maruito Nishi-Umeda Bid 3F, 3-3-45, Umeda, Kita-ku, Osaka, 5630-0001, Japan
TEL	06-4797-5660
Email	yamasaki@amc-clinic.jp

Public contact
Name of contact person	Clinical
Organization	Bell Medical Solutions Inc.
Division name	Clinical Research and Development
Address	1-3-7, Shiromi, Chuo-ku, Osaka 540-6313, Japan
TEL	06-6920-7589
Homepage URL
Email	nakano.satomi@bell-medical.co.jp

Sponsor
Institute	Medical Corporation KYOSOKAI AMC Nishi Umeda Clinic
Institute
Department

Funding Source
Organization	Taisho toyama pharmaceutical Co., Ltd
Organization
Division
Category of Funding Organization	Profit organization
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funｄer(s)

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	2015 Year 11 Month 06 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2015 Year 10 Month 16 Day
Anticipated trial start date	2015 Year 11 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information

Management information
Registered date	2015 Year 11 Month 06 Day
Last modified on	2017 Year 11 Month 22 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000022388