UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000018085 |
|---|---|
| Receipt number | R000020723 |
| Scientific Title | The study of effects of Canagliflozin ON T2DM patients' glycemic value Reduction and On Lowering dosage of insulin therapy |
| Date of disclosure of the study information | 2015/07/01 |
| Last modified on | 2018/03/28 09:59:21 |
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Basic information
Public title
The study of effects of Canagliflozin ON T2DM patients' glycemic value Reduction and On Lowering dosage of insulin therapy
Acronym
CONTROL Study
Scientific Title
The study of effects of Canagliflozin ON T2DM patients' glycemic value Reduction and On Lowering dosage of insulin therapy
Scientific Title:Acronym
CONTROL Study
Region
| Japan |
Condition
Condition
Type 2 diabetes
Classification by specialty
| Endocrinology and Metabolism |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the effects of canagliflozin on lowering insulin dosage, eliminating glucotoxity, and improving glycemic control, as well as safety of Japanese T2DM patients who use insulin therapy
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Change of the amount of insulin dosage (unit) per day from baseline to the 2nd week
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
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: Canagliflozin add-on to insulin group
Interventions/Control_2
Group B: Control (insulin only)
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
| Not applicable |
Age-upper limit
| 75 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Only those patients who meet all of the following criteria are included in this study:
1. T2DM patients who are on insulin monotherapy, or use insulin with DPP-4i, biguanide (BG), thiazolidinedione-based (TZD), or alpha-GI medicine regardless of insulin type, dosage, or frequency
2. Patients who are admitted into the hospital to improve their glycemic control
3. Patients who have not changed the amount, or switched to other pharmacological therapy except insulin in last 12 weeks
4. HbA1>=7%
5. Female or male patients aged 75 years or younger when giving their written consent
6. BMI>=24
7. Patients who can provide their written consent to participate in this study
Key exclusion criteria
For those who fall into any of the following criteria are excluded from the study:
1. Patients who use SGLT2, GLP-1, SU, or glinide within last 12 weeks just before giving their consent
2. Patients who are dehydrated
3. Patients who are on emulgent
4. Patients who are hospitalized as a result of sick day
5. Patients with serious infection or injury, or perioperative patients
6. Patients with a history of myocardial infarction, angina, stroke, or cerebral infarction
7. Patients with moderate renal dysfunction (eGFR<45mL/min/1.73m2)
8. Patients with severe liver functional impairment (AST>=100 IU/L)
9. Patients with moderate to severe heart failure as class 3 or worse based on the New York Heart Association (NYHA) Functional Classification
10. Patients with urinary tract infection, or genital infection
11. Patients with a malignant tumor or have a history of malignant tumor (exceptions: those are not on medication for malignant tumor, and have no recurrence of the disease so far and without recurrence risks during this study are allowed to participate)
12. If canagliflozin is prohibited to use
13. Patients with other conditions that are judged by a physician to be inappropriate to this study
Target sample size
58
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Yosuke Okada |
Organization
University of Occupational and Environmental Health
Division name
The First Department of Internal Medicine
Zip code
Address
1-1 Iseigaoka, Yahata Nishi-ku, Kitakyushu-shi, Fukuoka
TEL
093-603-1611
y-okada@med.uoeh-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Hiroki Takayama |
Organization
Soiken Inc.
Division name
Clinical Study Support
Zip code
Address
NBF Bld. 4th Floor, 1-3-1 Ogawamachi, Kanda, Chiyoda-ku, Tokyo
TEL
03-3295-1350
Homepage URL
takayama@soiken.com
Sponsor or person
Institute
University of Occupational and Environmental Health
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 | 07 | Month | 01 | 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
| 2015 | Year | 06 | Month | 03 | Day |
Date of IRB
Anticipated trial start date
| 2015 | Year | 08 | Month | 01 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2015 | Year | 06 | Month | 25 | Day |
Last modified on
| 2018 | Year | 03 | Month | 28 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000020723
