UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000022718 |
|---|---|
| Receipt number | R000026159 |
| Scientific Title | Combination of Canagliflozin with reduced dose of Sulfonylurea in Japanese type2 diabetic patients |
| Date of disclosure of the study information | 2016/06/15 |
| Last modified on | 2017/06/14 15:38:31 |
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Basic information
Public title
Combination of Canagliflozin with reduced dose of Sulfonylurea in Japanese type2 diabetic patients
Acronym
CCSJ
Scientific Title
Combination of Canagliflozin with reduced dose of Sulfonylurea in Japanese type2 diabetic patients
Scientific Title:Acronym
CCSJ
Region
| Japan |
Condition
Condition
type2 diabetes
Classification by specialty
| Endocrinology and Metabolism |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the efficacy and safety of canagliflozin when administered in combination with a half dose of preceding sulfonylurea (SU) in Japanese type 2 diabetes mellitus (T2DM) patients.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
HbA1c, glycoalbumin, FPG, and daily profile of blood glucose and glycemic variability evaluated by CGMs
Key secondary outcomes
weight, systolic BP, diastolic BP, HOMA-R, HOMA-beta, fasting CPR index, LDL-cholestrrol , HDL-cholestrrol, triglyceride, free fatty acid, hematocrit, creatinine, uric acid, urine ketone body, blood ketone body, urinary sediment, and CRP
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
At the beginning of the study, the dose of previously prescribed SU, irrespective of the type and dose, was reduced by half and concomitant administration of canagliflozin 100mg/day was initiated.
Interventions/Control_2
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
| 80 | years-old | > |
Gender
Male and Female
Key inclusion criteria
age range 20-80 years; type 2 diabetes treated with SU for >12 weeks; and HbA1c >6.5 and <9.0 at screening.
Key exclusion criteria
estimated glomerular filtration rate (eGFR) <45 ml/min/1.73 m2 (using the MDRD equation); acute coronary syndrome, stroke, or transient ischemic attack within 3 months prior to consent; severe liver dysfunction.
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Mitsuru Hashiramoto |
Organization
Yodogawa Christian Hospital
Division name
Division of Diabetes and Endocrinology
Zip code
Address
1-7-50, Kunijima, Higashi Yodogawa-ku, Osaka, Japan
TEL
+81-6-6322-2250
m-hashira@mitsuru-cl.com
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Mayuko Harada |
Organization
Yodogawa Christian Hospital
Division name
Division of Diabetes and Endocrinology
Zip code
Address
1-7-50, Kunijima, Higashi Yodogawa-ku, Osaka, Japan
TEL
+81-6-6322-2250
Homepage URL
kfmayuko4621@gmail.com
Sponsor or person
Institute
Yodogawa Christian Hospital
Institute
Department
Personal name
Funding Source
Organization
no
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
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
Other administrative information
Date of disclosure of the study information
| 2016 | Year | 06 | Month | 15 | Day |
Related information
URL releasing protocol
Publication of results
Published
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
| 2014 | Year | 12 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2014 | Year | 12 | Month | 01 | Day |
Last follow-up date
| 2016 | Year | 11 | 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
| 2016 | Year | 06 | Month | 13 | Day |
Last modified on
| 2017 | Year | 06 | Month | 14 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000026159
| Research Plan | |
|---|---|
| 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 |
