UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Exploratory study for SGLT2 inhibitor -Glucose lowering action, influences of dietary habits/exercise habits on therapeutic effects, and treatment satisfaction
Title of the study (Brief title)	Canak
Region	Japan

Condition
Condition	Type 2 diabetes mellitus
Classification by specialty	Endocrinology and Metabolism
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To evaluate benefits of Canagliflozin prospectively in poorly glycemic controlled patients with type 2 diabetes nevertheless who is only on diet/exercise therapy or undergoes oral antidiabetics (DPP-4 inhibitor, Sulfonylurea, Metformin etc.) in addition to diet/exercise therapy in terms of blood glucose-lowering action, treatment satisfaction from a patient's perspective, and the influence of dietary and exercise habits
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	- Change in HbA1c from baseline to the end of treatment period - Change in score of Diabetes Treatment Satisfaction by using DTSQ(Diabetes Treatment Satisfaction Questionnaire) from baseline to the end of treatment period. -Change in dietary habits and/or exercise habits by using FFQg(Food Frequency Questionnaire Based on Food Groups)from baseline to the end of treatment period
Key secondary outcomes	Change or change rate in following items from baseline to the end of treatment period Fasting plasma glucose(or Casual plasma glucose), Insulin(Only fasting), Weight, BMI, Waist circumference, Body composition, Blood pressure(systolic blood pressure, diastolic blood pressure), Lipid parameter[total cholesterol(TC), HDL-C, LDL-C,non HDL-C, triglyceride(TG), Free fatty acid(FFA)], LDL-C/ HDL-C ratio, Leptin

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	Orally administration of 100mg canagliflozin once a day, pre or post breakfast for 12months
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) 20 years and older at providing consent 2) Outpatients providing written informed consent 3) Male and Female 4) Poorly efected only diet/exercise therapy or poorly controlled glucose level whereas undergoing diet/exercise therapy in addition to oral antidiabetics (DPP-4 inhibitor, Sulfonylurea, Metformin etc.) at least 12 weeks 5) 10.0%>=HbA1c(NGSP)>=6.5% 6) Possibility of answer for diet/exercise therapy and DTSQ(Diabetes Treatment Satisfaction Questionnaire)
Key exclusion criteria	1) Received SGLT 2 inhibitors within 6 months before providing consent 2) Type 1 diabetes 3) Severe ketosis, diabetic coma or precoma within 6 months 4) Treatment with Insulin preparation and/or GLP -1 receptor agonist 5) Severe infection, been pre-/post-surgery, and serious trauma 6) Severe hepatic dysfunction 7) Moderate or severe renal dysfunction 8) Hypersensitivity to any ingredient of the study drug 9) Urinary tract infection and genital infection 10) Contraindications to undergoing oral hypoglycemic agents (DPP-4 inhibitor, Sulfonylurea, Metformin etc.) 11) Enrolled in other current clinical trials 12) Pregnancy, nursing and possibility of pregnant or plan to pregnant 13) Considered as inadequate by the principal investigator or investigator
Target sample size	150

Research contact person
Name of lead principal investigator	Ikuro Matsuba
Organization	Matsuba Medical Clinic
Division name	Medical director
Address	2-159 Tsukagoshi, Saiwai Ward, Kawasaki City, Kanagawa, Japan
TEL	044-522-1678
Email	ikuro@matsuba-web.com

Public contact
Name of contact person	Masako Kusano
Organization	I'cros Japan Co.,Ltd
Division name	Drug Information Support Department
Address	2-10-2 Fujimi, Chiyoda-ku, Tokyo 102-0071
TEL	03-3237-3641
Homepage URL
Email	m-kusano@icros.co.jp

Sponsor
Institute	Kanagawa Physicians Association
Institute
Department

Funding Source
Organization	Mitsubishi Tanabe Pharma Corporation
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 03 Month 31 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2016 Year 05 Month 25 Day
Anticipated trial start date	2016 Year 06 Month 09 Day
Last follow-up date	2017 Year 11 Month 27 Day
Date of closure to data entry
Date trial data considered complete	2018 Year 02 Month 06 Day
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 03 Month 31 Day
Last modified on	2018 Year 10 Month 01 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000019712