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

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 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


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

Value
https://center6.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