UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000030343 |
|---|---|
| Receipt number | 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 | 2022/10/26 12:02:05 |
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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
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
kasa@naramed-u.ac.jp
Sponsor or person
Institute
National Cerebral and Cardiovascular Center
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000032969
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| Registered date | File name |
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