UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000014922
Receipt number R000017363
Scientific Title Effect of Dapagliflozin in patients with type 2 daibetes mellitus
Date of disclosure of the study information 2014/08/23
Last modified on 2015/02/07 17:39:13

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Basic information

Public title

Effect of Dapagliflozin in patients with type 2 daibetes mellitus

Acronym

Effect of Dapagliflozin in patients with type 2 daibetes mellitus

Scientific Title

Effect of Dapagliflozin in patients with type 2 daibetes mellitus

Scientific Title:Acronym

Effect of Dapagliflozin in patients with type 2 daibetes mellitus

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 purpose of this study is to assess the effect of therapy of Dapaglyflozin on glycemic control and clinical parameters in patients with type 2 diabetes

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

The predictive parameters for the effect on Dapaglyflozin

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

Dapagliflozin

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

85 years-old >=

Gender

Male and Female

Key inclusion criteria

Type 2 diabetes with HbA1c =/> 6.5%

Key exclusion criteria

1. Type 1 diabetes
2. Patients with severe renal failure or liver dysfunction
3. Patients with drug allergy for ipraglifrozin
4. Patients with history of diabetec ketosis
5. Patients with shick day

Target sample size

50


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Tomoyuki Iwasaki

Organization

Iwasaki Naika Clinic

Division name

Endocrinology and Metabolism

Zip code


Address

1-1-5-1F Kamihoshikawa, Hodogayaku, Yokohama, Kanagawa, Japan

TEL

045-442-6475

Email

toiwasaki-dm@umin.ac.jp


Public contact

Name of contact person

1st name
Middle name
Last name Tomoyuki Iwasaki

Organization

Iwasaki Naika Clinic

Division name

Endocrinology and Metabolism

Zip code


Address

1-1-5-1F Kamihoshikawa, Hodogayaku, Yokohama, Kanagawa, Japan

TEL

045-442-6475

Homepage URL


Email

toiwasaki-dm@umin.ac.jp


Sponsor or person

Institute

Iwasaki Naika Clinic

Institute

Department

Personal name



Funding Source

Organization

Iwasaki Naika Clinic

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



Other administrative information

Date of disclosure of the study information

2014 Year 08 Month 23 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 08 Month 22 Day

Date of IRB


Anticipated trial start date

2014 Year 08 Month 23 Day

Last follow-up date

2015 Year 01 Month 23 Day

Date of closure to data entry

2015 Year 01 Month 31 Day

Date trial data considered complete

2015 Year 02 Month 01 Day

Date analysis concluded

2015 Year 02 Month 01 Day


Other

Other related information



Management information

Registered date

2014 Year 08 Month 22 Day

Last modified on

2015 Year 02 Month 07 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000017363


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name