UMIN-CTR Clinical Trial

Basic information
Public title	Comparison of canagliflozin vs. tenegliptin against basic metabolic risks in patients with type 2 diabetes mellitus
Acronym	CANTABILE study
Scientific Title	Comparison of canagliflozin vs. tenegliptin against basic metabolic risks in patients with type 2 diabetes mellitus
Scientific Title:Acronym	CANTABILE study
Region	Japan

Condition
Condition	T2DM patients with basic metabolic risks
Classification by specialty	Endocrinology and Metabolism
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To assess potential effects of 24 week treatment with canagliflozin or teneligliptin (target HbA1c of less than 7.0%) on metabolic risk factors in patients with type 2 diabetes mellitus.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Rate of subjects who meet one or more of the below criteria : Composite endpoints (a) BMI 25 kg/m2 or more at 0 week of treatment and show 3% or more weight loss at 24 week of treatment. (b) Systolic blood pressure of 130 mmHg or more or diastolic blood pressure of 85 mmHg or more at 0 week and show systolic blood pressure of less than 130 mmHg and diastolic blood pressure of less than 85 mmHg at 24 week of treatment. (c) Fasting triglyceride of 150 mg/dL or more or HDL-C of less than 40 mg/dL at 0 week and fasting triglycreride of less than 150 mg/dL and HDL-C of 40 mg/dL or more at 24 week of treatment.
Key secondary outcomes

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Open -no one is 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	Group A: Teneligliptin group : Orally given one tablet of TENELIA 20mg daily from the next day of the 0 week clinic visit until the 24 week of treatment. If the doctor in charge finds it suitable during the treatment with 20mg, dose escalation up to 40mg (2 tablets) once daily is allowed.
Interventions/Control_2	Group B: Canagliflozin group : Orally given one tablet of CANAGLU 100mg daily either before or after breakfast from the next day of the 0 week clinic visit until the 24 week of treatment.
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	85 years-old >
Gender	Male and Female
Key inclusion criteria	1. Written informed consent by the patient 2. 20 years old or older, less than 85 years old 3. HbA1c of 7.0% or higher and less than 10.0% 4. Fulfill one or more of the following criteria on the date of consent; - BMI 25 kg/m2 or higher - Systolic blood pressure of 130 mmHg or higer, or diastolic blood pressure of 85 mmHg or higher -Fasting triglyceride of 150 mg/dL or higher, or HDL-C of less than 40 mg/dL 5. No anti-diabetic medication during the preceding 8 weeks, or have been receiving fixed dose metformin hydrochloride monotherapy during the preceding 8 weeks 6. Undertaking dietary and exercise therapy of the same intensity/content during the preceding 8 weeks. Exercise is not mandatory If exercise is not recommended due to complications.
Key exclusion criteria	1. Type 1 diabetes mellitus 2. BMI of 22 kg/m2 or less 3. Hypersensitivity to contents of TENELIA or CANAGLU 4. Require insulin therapy (Severe ketosis, diabetic coma or precoma, severe infection, perioperative, severe trauma etc.) 5. Congestive heart failure of NYHA III or IV 6. Pregnancy, possible pregnancy, or lactating 7. Malignancy or suspected malignancy 8. Taking unallowed medications or undertaking unallowed therapy defined in the study protocol during the preceding 8 weeks 9. Changes in dosage of concomittantly administered drugs or therapy contents during the preceding 8 weeks 10. Other subjects deemed unsuitable by the doctor in charge of the research
Target sample size	200

Research contact person
Name of lead principal investigator	1st name Kiminori Middle name Last name Hosoda
Organization	National Cerebral and Cardiovascular Center
Division name	Division of Endocrinology and Metabolism
Zip code	5648565
Address	6-1 Kishibe-shinmachi, Suita, Osaka 565-8565, Japan.
TEL	06-6170-1070
Email	kiminorihosoda@ncvc.go.jp

Public contact
Name of contact person	1st name Masato Middle name Last name Kasahara
Organization	Nara Medical University
Division name	Clinical Research Center
Zip code	6348522
Address	840 Shijo cho Kashihara, Nara 634-8522,Japan
TEL	0744-22-3051
Homepage URL
Email	kasa@naramed-u.ac.jp

Sponsor
Institute	National Cerebral and Cardiovascular Center
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)

IRB Contact (For public release)
Organization	Nara Medical University Certified Review Board
Address	Nara 840 Shijo-Cho, Kashihara, Nara, Japan
Tel	0744-29-8835
Email	ethics_nara@naramed-u.ac.jp

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

関西医科大学附属病院 国立循環器病研究センター 協和会病院 ホリイ内科クリニック 名古屋市立大学病院 名古屋市立東部医療センター 名古屋市立西部医療センター 山の手内科クリニック 医療法人松徳会　松本クリニック ちゅうしょクリニック 医療法人社団梨慶会　するがクリニック 医療法人財団博愛会　ウェルネス天神クリニック 医療法人社団恵樹会　いたばし糖尿病内科皮フ科クリニック 医療法人社団ほたるの博優会 医療法人社団壮州会　サトウ内科クリニック 独立行政法人地域医療機能推進機構　四日市羽津医療センター 医療法人社団ふさの会 しみずクリニックふさ 東芝林間病院 国立内科クリニック 医療法人王心会 新田東クリニック 和歌山県立医科大学 医療法人憲諒会 真鍋医院 医療法人新生会　総合病院 高の原中央病院 医療法人萬田記念病院 医療法人社団 知正会 東京センタークリニック 医療法人社団かいしん会　ますなが医院 社会福祉法人 大阪暁明館病院 医療法人共創会 AMC西梅田クリニック 医療法人友愛会　沢田医院 医療法人友愛会　かつらぎクリニック 医療法人友愛会　しらかしクリニック

Other administrative information
Date of disclosure of the study information	2018 Year 01 Month 05 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	2017 Year 11 Month 30 Day
Date of IRB	2017 Year 09 Month 29 Day
Anticipated trial start date	2018 Year 01 Month 05 Day
Last follow-up date	2019 Year 09 Month 30 Day
Date of closure to data entry
Date trial data considered complete	2019 Year 11 Month 08 Day
Date analysis concluded	2019 Year 12 Month 27 Day

Other
Other related information

Management information
Registered date	2017 Year 12 Month 11 Day
Last modified on	2022 Year 10 Month 26 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000032969