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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000030343
Receipt No. R000032969
Scientific Title Comparison of canagliflozin vs. tenegliptin against basic metabolic risks in patients with type 2 diabetes mellitus
Date of disclosure of the study information 2018/01/05
Last modified on 2019/07/04

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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 0744-29-8836
Homepage URL
Email cantabile@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

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 No longer recruiting
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
2020 Year 09 Month 30 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2017 Year 12 Month 11 Day
Last modified on
2019 Year 07 Month 04 Day


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

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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