UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000020086
Receipt number R000023197
Scientific Title The multicenter clinical study of the relation between a SGLT2 inhibitor and the hormones regulating appetite in the patients with type 2 diabetes
Date of disclosure of the study information 2015/12/14
Last modified on 2016/02/25 15:01:11

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Basic information

Public title

The multicenter clinical study of the relation between a SGLT2 inhibitor and the hormones regulating appetite in the patients with type 2 diabetes

Acronym

Study for the relation between a SGLT2 inhibitor and the hormones regulating appetite

Scientific Title

The multicenter clinical study of the relation between a SGLT2 inhibitor and the hormones regulating appetite in the patients with type 2 diabetes

Scientific Title:Acronym

Study for the relation between a SGLT2 inhibitor and the hormones regulating appetite

Region

Japan


Condition

Condition

Type 2 diabetes

Classification by specialty

Endocrinology and Metabolism

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To clarify the relation between a SGLT2 inhibitor (Canagliflozin) and the changes of hormones regulating appetite

Basic objectives2

Safety,Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

The changes of the hormones regulating appetite (active ghrelin and PYY) after 12 weeks from start of administrating of Canagliflozin

Key secondary outcomes



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

Oral administration of 100 mg Canagliflozin once a day after breakfast for 24 weeks

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

65 years-old >

Gender

Male and Female

Key inclusion criteria

1. Patients under diet therapy and exercise
2. Patients without medicine or with under 2 types of diabetic medicines for 2 months except for an another SGLT2 inhibitor
3. HbA1c (NGSP) over 7.0 % or under 10 %
4. Patients who can understand the study and agree with the study by the document

Key exclusion criteria

1. Patients with an allergy to Canagliflozin
2. Patients with diabetic ketoacidosis, diabetic coma and type 1 diabetes
3. Patients with over 2 times from upper limit of normal ranges of AST, ALT, or gamma-GTP
4. Patients with under 45 ml/min/1.73m2 of eGFR
5. Patients with severe inflammation or injury, or before or after operation
6. Patients with cancer or inflammatory bowel disease, or after operation of GI tracts
7. Patients with pregnancy or during lactation
8. Patients who are thought to be unsuitable for the study by the attending doctor

Target sample size

100


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Naotsuka Okayama

Organization

Nagoya City University Graduate School of Medical Sciences

Division name

Department of Gastroenterology and Metabolism

Zip code


Address

1 Kawasumi, Mizuho-cho, Mizuho-ku, Nagoya, Japan

TEL

052-853-8211

Email

nokaya@med.nagoya-cu.ac.jp


Public contact

Name of contact person

1st name
Middle name
Last name Naotsuka Okayama

Organization

Nagoya City University Graduate School of Medical Sciences

Division name

Department of Gastroenterology and Metabolism

Zip code


Address

1 Kawasumi, Mizuho-cho, Mizuho-ku, Nagoya, Japan

TEL

052-853-8211

Homepage URL


Email

nokaya@med.nagoya-cu.ac.jp


Sponsor or person

Institute

Department of Gastroenterology and Metabolism, Nagoya City University Graduate School of Medical Sciences

Institute

Department

Personal name



Funding Source

Organization

Department of Gastroenterology and Metabolism, Nagoya City University Graduate School of Medical Sciences

Organization

Division

Category of Funding Organization

Self funding

Nationality of Funding Organization



Other related organizations

Co-sponsor

Nagoya City East Medical Center
Nagoya City West Medical Center
Kariya Toyota General Hospital
Chita Kosei Hospital
Asahi Rousai Hospital
Toyokawa City Hospital
Nishitita General Hospital
Takahashi Family Clinic
Okouchi Internal Medicine Clinic

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

名古屋市立大学病院(愛知県)、名古屋市立東部医療センター(愛知県)、名古屋市立西部医療センター(愛知県)、刈谷豊田総合病院(愛知県)、愛知県厚生連知多厚生病院(愛知県)、旭労災病院(愛知県)、豊川市民病院(愛知県)、公立西知多総合病院(愛知県)、高橋ファミリークリニック(愛知県)、おおこうち内科クリニック(愛知県)、


Other administrative information

Date of disclosure of the study information

2015 Year 12 Month 14 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

Enrolling by invitation

Date of protocol fixation

2015 Year 12 Month 02 Day

Date of IRB


Anticipated trial start date

2015 Year 12 Month 14 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 12 Month 06 Day

Last modified on

2016 Year 02 Month 25 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000023197


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name