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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000018085
Receipt No. 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

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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
Email 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
Email takayama@soiken.com

Sponsor
Institute University of Occupational and Environmental Health
Institute
Department

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
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

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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000020723

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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