UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	The study of effects of Canagliflozin ON T2DM patients' glycemic value Reduction and On Lowering dosage of insulin therapy
Title of the study (Brief title)	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	Yosuke Okada
Organization	University of Occupational and Environmental Health
Division name	The First Department of Internal Medicine
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	Hiroki Takayama
Organization	Soiken Inc.
Division name	Clinical Study Support
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)

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

Progress
Recruitment status	Completed
Date of protocol fixation	2015 Year 06 Month 03 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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