UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000016993 |
|---|---|
| Receipt number | R000019712 |
| Scientific Title | Exploratory study for SGLT2 inhibitor -Glucose lowering action, influences of dietary habits/exercise habits on therapeutic effects, and treatment satisfaction |
| Date of disclosure of the study information | 2015/03/31 |
| Last modified on | 2018/10/01 12:47:02 |
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Basic information
Public title
Exploratory study for SGLT2 inhibitor -Glucose lowering action, influences of dietary habits/exercise habits on therapeutic effects, and treatment satisfaction
Acronym
Canak
Scientific Title
Exploratory study for SGLT2 inhibitor -Glucose lowering action, influences of dietary habits/exercise habits on therapeutic effects, and treatment satisfaction
Scientific Title:Acronym
Canak
Region
| Japan |
Condition
Condition
Type 2 diabetes mellitus
Classification by specialty
| Endocrinology and Metabolism |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate benefits of Canagliflozin prospectively in poorly glycemic controlled patients with type 2 diabetes nevertheless who is only on diet/exercise therapy or undergoes oral antidiabetics (DPP-4 inhibitor, Sulfonylurea, Metformin etc.) in addition to diet/exercise therapy in terms of blood glucose-lowering action, treatment satisfaction from a patient's perspective, and the influence of dietary and exercise habits
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
- Change in HbA1c from baseline to the end of treatment period
- Change in score of Diabetes Treatment Satisfaction by using DTSQ(Diabetes Treatment Satisfaction Questionnaire) from baseline to the end of treatment period.
-Change in dietary habits and/or exercise habits by using FFQg(Food Frequency Questionnaire Based on Food Groups)from baseline to the end of treatment period
Key secondary outcomes
Change or change rate in following items from baseline to the end of treatment period
Fasting plasma glucose(or Casual plasma glucose), Insulin(Only fasting), Weight, BMI, Waist circumference, Body composition, Blood pressure(systolic blood pressure, diastolic blood pressure), Lipid parameter[total cholesterol(TC), HDL-C, LDL-C,non HDL-C, triglyceride(TG), Free fatty acid(FFA)], LDL-C/ HDL-C ratio, Leptin
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
Orally administration of 100mg canagliflozin once a day, pre or post breakfast for 12months
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1) 20 years and older at providing consent
2) Outpatients providing written informed consent
3) Male and Female
4) Poorly efected only diet/exercise therapy or poorly controlled glucose level whereas undergoing diet/exercise therapy in addition to oral antidiabetics (DPP-4 inhibitor, Sulfonylurea, Metformin etc.) at least 12 weeks
5) 10.0%>=HbA1c(NGSP)>=6.5%
6) Possibility of answer for diet/exercise therapy and DTSQ(Diabetes Treatment Satisfaction Questionnaire)
Key exclusion criteria
1) Received SGLT 2 inhibitors within 6 months before providing consent
2) Type 1 diabetes
3) Severe ketosis, diabetic coma or precoma within 6 months
4) Treatment with Insulin preparation and/or GLP -1 receptor agonist
5) Severe infection, been pre-/post-surgery, and serious trauma
6) Severe hepatic dysfunction
7) Moderate or severe renal dysfunction
8) Hypersensitivity to any ingredient of the study drug
9) Urinary tract infection and genital infection
10) Contraindications to undergoing oral hypoglycemic agents (DPP-4 inhibitor, Sulfonylurea, Metformin etc.)
11) Enrolled in other current clinical trials
12) Pregnancy, nursing and possibility of pregnant or plan to pregnant
13) Considered as inadequate by the principal investigator or investigator
Target sample size
150
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Ikuro Matsuba |
Organization
Matsuba Medical Clinic
Division name
Medical director
Zip code
Address
2-159 Tsukagoshi, Saiwai Ward, Kawasaki City, Kanagawa, Japan
TEL
044-522-1678
ikuro@matsuba-web.com
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Masako Kusano |
Organization
I'cros Japan Co.,Ltd
Division name
Drug Information Support Department
Zip code
Address
2-10-2 Fujimi, Chiyoda-ku, Tokyo 102-0071
TEL
03-3237-3641
Homepage URL
m-kusano@icros.co.jp
Sponsor or person
Institute
Kanagawa Physicians Association
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
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
| 2015 | Year | 03 | Month | 31 | 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
| 2016 | Year | 05 | Month | 25 | Day |
Date of IRB
Anticipated trial start date
| 2016 | Year | 06 | Month | 09 | Day |
Last follow-up date
| 2017 | Year | 11 | Month | 27 | Day |
Date of closure to data entry
Date trial data considered complete
| 2018 | Year | 02 | Month | 06 | Day |
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2015 | Year | 03 | Month | 31 | Day |
Last modified on
| 2018 | Year | 10 | Month | 01 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000019712
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