UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000030208
Receipt No. 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

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


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
Email 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
Email prj-mt2017-001@eps.co.jp

Sponsor
Institute Osaka University Hospital
Institute
Department

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
Email

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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000034505

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.