UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000014306
Receipt number R000016658
Scientific Title Efficacy and safety of Ipragliflozin in patients with type 2 diabetes who have inadequate glycemic control.
Date of disclosure of the study information 2014/06/18
Last modified on 2015/11/19 11:05:06

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Basic information

Public title

Efficacy and safety of Ipragliflozin in patients with type 2 diabetes who have inadequate glycemic control.

Acronym

Efficacy and safety of Ipragliflozin in patients with type 2 diabetes who have inadequate glycemic control.

Scientific Title

Efficacy and safety of Ipragliflozin in patients with type 2 diabetes who have inadequate glycemic control.

Scientific Title:Acronym

Efficacy and safety of Ipragliflozin in patients with type 2 diabetes who have inadequate glycemic control.

Region

Japan


Condition

Condition

Type 2 diabetes

Classification by specialty

Endocrinology and Metabolism

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

Clinical study to determine the safest use of Ipragliflozin in patients with type 2 diabetes who have inadequate glycemic control by diet therapy, exercise therapy, oral antidiabetic drugs, by InBody, which observes composition of the weight, and CGM, which observes glucose variability.

Basic objectives2

Safety,Efficacy

Basic objectives -Others


Trial characteristics_1

Exploratory

Trial characteristics_2

Pragmatic

Developmental phase

Not applicable


Assessment

Primary outcomes

Change in Glycosylated hemoglobin (HbA1c) levels over 6 months.

Key secondary outcomes

1) Change in fasting blood glucose, body weight, waist circumference, IRI, serum lipid and body composition over 6 months.
2)CGM


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

Current treatment + Ipragliflozin

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


Not applicable

Gender

Male and Female

Key inclusion criteria

(1) HbA1c levels of >=6.5% to <8.5%, as defined by the National Institutes of Diabetes and Digestive and Kidney Diseases
(2) Age >=20years on the date of submission of informed consent
(3) Under treatment with fixed diet and exercise therapy >=8weeks
(4) When treated with oral antidiabetic drugs; under treatment with a fixed dose and regimen >=8 weeks
(5) Submission of written informed consent for participation in this study

Key exclusion criteria

(1) Type-1 diabetes, diabetes due to a pancreatic disorder, or secondary diabetes due to conditions
(2) Application of contraindications contained in the package insert
(3) Severe renal function disorder
(4 )BMI is < 22kg/m2
(5) Under treatment with insulin,GLP-1 analog,or SGLT-2 inhibitor
(6) Pregnant women, women suspected of being pregnant, or lactating women
(7) Participation in the study is judged by the investigator or sub-investigator as inappropriate for any other reason

Target sample size

100


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Takeshi Osonoi

Organization

Nakakinen clinic

Division name

Director

Zip code


Address

745-5, Nakadai, Naka, Ibaraki

TEL

029-353-2800

Email

t-osonoi@kensei-kai.com


Public contact

Name of contact person

1st name
Middle name
Last name Kensuke Ofuchi

Organization

Nakakinen clinic

Division name

Clinical Laboratory

Zip code


Address

745-5, Nakadai, Naka, Ibaraki

TEL

029-353-2800

Homepage URL


Email

k-ofuchii@kensei-kai.com


Sponsor or person

Institute

Nakakinen clinic

Institute

Department

Personal name



Funding Source

Organization

Astellas Pharma Inc.

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

仲本内科クリニック(茨城県)、那珂記念MITOクリニック(茨城県)


Other administrative information

Date of disclosure of the study information

2014 Year 06 Month 18 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

2014 Year 05 Month 01 Day

Date of IRB


Anticipated trial start date

2014 Year 06 Month 27 Day

Last follow-up date

2015 Year 08 Month 31 Day

Date of closure to data entry

2015 Year 08 Month 31 Day

Date trial data considered complete

2015 Year 11 Month 10 Day

Date analysis concluded

2015 Year 11 Month 19 Day


Other

Other related information



Management information

Registered date

2014 Year 06 Month 18 Day

Last modified on

2015 Year 11 Month 19 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000016658


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name