UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	The protective effect of canagliflozin on renal function in obese patients with T2DM
Title of the study (Brief title)	The protective effect of canagliflozin on renal function in obese patients with T2DM
Region	Japan

Condition
Condition	Obese T2DM with nephropathy
Classification by specialty	Endocrinology and Metabolism Nephrology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To determine the protective effect of canagliflozin on renal function in obese patients with T2DM.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1	Exploratory
Trial characteristics_2	Pragmatic
Developmental phase

Assessment
Primary outcomes	Change of eGFR slope
Key secondary outcomes	Blood evaluation: HbA1c, eGFR, serum Cr, cystatin C, Uriva acid, T-chol, HDL-chol, TG Urine evaluation: ACR, 24hCCr, Urine volume, Na, K, Cl, L-FABP, B2-Mg, NAG, glucose and protein Blood pressure at office

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	Addition of canagliflozin (100mg once daily) to standard therapy for one year.
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	70 years-old >
Gender	Male and Female
Key inclusion criteria	1) Obtained written informed consent 2) Patients who eligible to following criteria; ACR > 30mg/gCr, eGFR > 45ml/min/1.73m2, BMI > 25 Kg/m2 or waist circumference > 85cm (men) 90cm (women), HbA1c 6.5-9.0% (NGSP) 3) Patients who wasnot prescribed SGLT2 inhibitors for more than 3 months at entry. 4) Patients who can visit the hospital throughout the study.
Key exclusion criteria	1) HbA1C >9.0% 2) Allergy to canagliflozin 3) Severe ketoacidosis or diabetic coma 4) severe infection, operation, and trauma 5)T1DM 6) Moderate to severe renal disfuction (eGFR <45ml/min/1.73m2) 7) Heart failure (NYHA IV) 8) possibility of hypoglycemia by canagliflozine such as hypopituitarism, adrenal insuficiency, excessive exercise, malnutition, excess alcohol intake. 9) Dehydration 10) severe liver disfunction (AST and ALT > 5 x normal range of the hospital) 11) Age more than 70 years 12) Age less than 20 years 13) Pregnant or breastfeeding mother 14) patients who was regarded as uneligible by the doctor
Target sample size	20

Research contact person
Name of lead principal investigator	Shuichi Tsuruoka
Organization	Nippon Medical School
Division name	Division of Nephrology
Address	1-1-5 Sendagi, Bunkyo-ku, Tokyo
TEL	03-3822-2131(ext6496)
Email	tsuruoka@nms.ac.jp

Public contact
Name of contact person	Shuichi Tsuruoka
Organization	Nippon Medical School
Division name	Division of Nephrology
Address	1-1-5 Sendagi, Bunkyo-ku, Tokyo
TEL	03-3822-2131(ext6496)
Homepage URL
Email	tsuruoka@nms.ac.jp

Sponsor
Institute	Division of Nephrology, Nippon Medical School
Institute
Department

Funding Source
Organization	Mitsubishi Tanabe Pharma Corporation
Organization
Division
Category of Funding Organization	Profit organization
Nationality of Funding Organization	Japan

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	日本医科大学付属病院（東京都）、東京慈恵会医科大学附属病院 （東京都）、東京医科大学病院（東京都）、自治医科大学附属病院（栃木県）

Other administrative information
Date of disclosure of the study information	2015 Year 09 Month 01 Day

Progress
Recruitment status	Terminated
Date of protocol fixation	2015 Year 08 Month 03 Day
Anticipated trial start date	2015 Year 12 Month 01 Day
Last follow-up date	2017 Year 08 Month 31 Day
Date of closure to data entry	2017 Year 08 Month 31 Day
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 08 Month 18 Day
Last modified on	2017 Year 12 Month 28 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000021628