UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000030208 |
|---|---|
| Receipt number | R000034505 |
| Scientific Title | Effect of canagliflozin on the disposition index, a marker of pancreatic beta-cell function, in type 2 diabetic patients: a randomized controlled study |
| Date of disclosure of the study information | 2018/03/28 |
| Last modified on | 2020/08/07 16:39:23 |
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Basic information
Public title
Effect of canagliflozin on the disposition index, a marker of pancreatic beta-cell function, in type 2 diabetic patients: a randomized controlled study
Acronym
Effect of canagliflozin on the disposition index, a marker of pancreatic beta-cell function, in type 2 diabetic patients: a randomized controlled study
(CANDI-beta STUDY)
Scientific Title
Effect of canagliflozin on the disposition index, a marker of pancreatic beta-cell function, in type 2 diabetic patients: a randomized controlled study
Scientific Title:Acronym
Effect of canagliflozin on the disposition index, a marker of pancreatic beta-cell function, in type 2 diabetic patients: a randomized controlled study
(CANDI-beta STUDY)
Region
| Japan |
Condition
Condition
Type 2 diabetes mellitus
Classification by specialty
| Endocrinology and Metabolism |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The aim of this study is to compare the effect between canagliflozin add-on group (additional administration of canagliflozin and dose adjustment of glimepiride) and glimepiride group (dose adjustment of glimepiride only) on pancreatic beta cell function in patients with type 2 diabetes who had inadequate glycemic control despite treatment with stable triple combination (teneligliptin, glimepiride and metformin) in addition to diet and exercise therapy.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Change in disposition index, calculated using blood glucose and insulin values, from baseline to at 1-week after the end of the treatment
Key secondary outcomes
Changes in
(1) DI-related outcomes
(2) DI using C-peptide
(3) HbA1c, fasting glucose, fasting insulin
(4) Body weight
(5) CGM glucose levels
(6) HOMA2-% B, iHOMA2 (-% B, -%S)
(7) HOMA2-%S
(8) Dose of glimepiride
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
Canagliflozin (100 mg/day) and glimepiride (0-4mg/day, adjusted by the prescribed algorithm), for 24 weeks
Interventions/Control_2
Glimepiride (0-4mg/day, adjusted by the prescribed algorithm), for 24 weeks
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
| 75 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1) Type 2 diabetic outpatients giving written informed consent for the study participation
2) Aged 20-75 years at informed consent
3) Not achieving the individual glycemic target, according to Treatment Guide for Diabetes 2016-2017, by Japan Diabetes Society
4) Undergoing unchanged diet and exercise therapy over 12 weeks
5) Treated with a constant dose of teneligliptin, glimepiride and metformin over 12 weeks (or treated with a constant dose of teneligliptin and glimepiride over 12 weeks, with reasonable reason for not taking metformin)
6) Not taking prohibited concomitant medications over 12 weeks
Key exclusion criteria
(1) Type 1 diabetes mellitus
(2) Need insulin treatment
(3) History of hypersensitivity to canagliflozin
(4) Heart failure (NYHA class IV)
(5) eGFR<45 mL/min/1.73 m2
(6) Severe hepatic dysfunction
(7) Pregnancy, nursing or planning to become pregnant during the study
(8) Suspected or diagnosed malignant tumors
(9) Participating in another interventional study
(10) Considered by a study physician to be inappropriate for any other reason
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Taka-aki Matsuoka |
Organization
Osaka University Hospital
Division name
Metabolic Medicine
Zip code
Address
2-15 Yamadaoka, Suita, Osaka,Japan
TEL
06-6879-3732
matsuoka@endmet.med.osaka-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Tatsuya Ota |
Organization
EP-CRSU Co., Ltd.
Division name
Clinical Research Management Department 1
Zip code
Address
Acropolis-Tokyo Bldg., 6-29 Shin-ogawamachi, Shinjuku-ku, Tokyo, Japan
TEL
03-5946-8264
Homepage URL
prj-mt2017-001@eps.co.jp
Sponsor or person
Institute
Osaka University Hospital
Institute
Department
Personal name
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)
IRB Contact (For public release)
Organization
Address
Tel
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
白岩内科医院（大阪府）/Shiraiwa Medical Clinic（Osaka）
Other administrative information
Date of disclosure of the study information
| 2018 | Year | 03 | Month | 28 | 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
| 2018 | Year | 02 | Month | 19 | Day |
Date of IRB
| 2018 | Year | 02 | Month | 22 | Day |
Anticipated trial start date
| 2018 | Year | 03 | Month | 28 | Day |
Last follow-up date
| 2019 | Year | 02 | Month | 20 | 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 | 01 | Day |
Last modified on
| 2020 | Year | 08 | Month | 07 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000034505
| Research Plan | |
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| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
