UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000013898
Receipt number R000016207
Scientific Title Efficacy and safety of SGLT2 inhibitor, Ipragliflozin in type 2 diabetes patients.
Date of disclosure of the study information 2014/05/07
Last modified on 2014/05/08 14:29:12

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Basic information

Public title

Efficacy and safety of SGLT2 inhibitor, Ipragliflozin in type 2 diabetes patients.

Acronym

Efficacy and Safety of SGLT2 inhibitor Ipragliflozin in type 2 diabetes patients.(ESST2)

Scientific Title

Efficacy and safety of SGLT2 inhibitor, Ipragliflozin in type 2 diabetes patients.

Scientific Title:Acronym

Efficacy and Safety of SGLT2 inhibitor Ipragliflozin in type 2 diabetes patients.(ESST2)

Region

Japan


Condition

Condition

Type 2 diabetes mellitus

Classification by specialty

Endocrinology and Metabolism

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

The aim of this study is to evaluate the efficacy and safety of Ipragliflozin, SGLT2 inhibitor which is a new oral hypoglycemic agent, by using continuous blood glucose monitoring under hospitalization in type 2 diabetes patients treated with diet and exercise therapy and/or oral hypoglycemic agent(metformin etc).

Basic objectives2

Safety,Efficacy

Basic objectives -Others


Trial characteristics_1

Exploratory

Trial characteristics_2

Pragmatic

Developmental phase

Not applicable


Assessment

Primary outcomes

(1)glucose metabolism: at the baseline and the end of the study.
1)HbA1c,1,5-AG
2)Fasting plasma glucose, insulin, HOMA-R
3)Blood ketone body, free fatty acid, Adiponectin
(2)The change of body weight/Body Mass Index(BMI)/body fat ratio: measuring every day through study period.
(3)Continuous Glucose Monitoring (CGM system-Gold TM): at the baseline and the end of the study period, we measure the blood glucose profile for 72 hours before and after Ipragliflozin treatment.

Key secondary outcomes

(1)24 hours urine glucose amount and electrolyte (include Na, Ca) excretion in urine:measuring at the baseline and during trial period, we measure the amount of urine sugar/24 hours and quantity of urine electrolyte under hospitalization.
(2)Lipid metabolism: serum T-chol, HDL-C, LDL-C, TG, RLP-chol, LP(a), small dense LDL, MDA-LDL: measuring at the baseline and the end of the study period.
(3)Liver function, renal function, hematocrit level, amino acid analysis, lactic acid, pyruvic acid, BNP etc, measuring at the baseline and the end of the study period.
(4)The markers of tubular impairment (such as urinary beta2-MG, urinary NAG, urinary type IV collagen, L-FABP):
measuring at the baseline and the end of the study period.


Base

Study type


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

SGLT-2 inhibitor(+)

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

70 years-old >

Gender

Male and Female

Key inclusion criteria

The outpatients with type 2 diabetes mellitus who are periodically visiting our hospital.
HbA1c(NGSP) level less than 10%,and type 2 diabetes patients who recieve diet and exercise therapy and/or taking oral hypoglycemic agents.
1.BMI >=22kg/m2and35kg/m2=<
2. age >=20
Male and Female

Key exclusion criteria

1.Patient who had myocardial infarction within the past six months.
2.Patient with a severe ketotic diabetic coma or precoma.
3.Patient with severe infectious disease (especially urinary tract infection), before and after operation, and a serious injury.
4.Patient with a past history of hypersensitivity for Ipragliflozin.
5.A pregnant woman or woman who may be pregnant.
6.Elderly person (>70 years).
7 Patient with hypoalimentation or dehydration.
8.Patient who is considered to be inappropriate by the chief physician.
During the entire study period,
when the chief physician judges that the continuing participation in this study became difficult, by aggravation such as HbA1c or blood glucose level and other factors, the appropriate treatment should be done immediately: administration of other antihyperglycemic agent or other appropriate measures.

Target sample size

15


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Eitaro Nakashima

Organization

Chubu-Rosai Hospital

Division name

Department of Diabetes and Endocrinology

Zip code


Address

1-10-6,koumei,Minato-ku Nagoya, Aichi, JAPAN

TEL

+81-52-6525511

Email

eitaro@med.nagoya-u.ac.jp


Public contact

Name of contact person

1st name
Middle name
Last name Minoru Kusama

Organization

Chubu-Rosai Hospital

Division name

Department of Diabetes and Endocrinology

Zip code


Address

1-10-6,koumei,Minato-ku Nagoya, Aichi, JAPAN

TEL

+81-52-6525511

Homepage URL


Email

minyoru1101@yahoo.co.jp


Sponsor or person

Institute

Chubu-Rosai Hospital
Department of Diabetes and Endocrinology

Institute

Department

Personal name



Funding Source

Organization

Chubu-Rosai Hospital
Department of Diabetes and Endocrinology

Organization

Division

Category of Funding Organization

Self funding

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

労働者健康福祉機構 中部労災病院(愛知県)


Other administrative information

Date of disclosure of the study information

2014 Year 05 Month 07 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

Preinitiation

Date of protocol fixation

2014 Year 04 Month 24 Day

Date of IRB


Anticipated trial start date

2014 Year 05 Month 11 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

2014 Year 05 Month 07 Day

Last modified on

2014 Year 05 Month 08 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000016207


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name