UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000015369
Receipt number R000017886
Scientific Title The study of dapagliflozin (sodium glucose cotransporter 2 inhibitor) to verify the efficacy of combination therapy in Japanese patients with type 2 diabetes
Date of disclosure of the study information 2014/10/08
Last modified on 2017/04/10 20:15:47

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Basic information

Public title

The study of dapagliflozin (sodium glucose cotransporter 2 inhibitor) to verify the efficacy of combination therapy in Japanese patients with type 2 diabetes

Acronym

DISCOVERY study

Scientific Title

The study of dapagliflozin (sodium glucose cotransporter 2 inhibitor) to verify the efficacy of combination therapy in Japanese patients with type 2 diabetes

Scientific Title:Acronym

DISCOVERY 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 investigate the efficacy and the safety of SGLT2 inhibitor, dapaglifrozin, in patients with type 2 diabetes

Basic objectives2

Safety,Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Change and percent change in HbA1c from baseline to 6 months

Adverse events

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

Orally administration of 5 mg dapagliflozin once a day for 6 months

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

75 years-old >=

Gender

Male and Female

Key inclusion criteria

1) Age: >= 20 and <= 75
2) HbA1c: >= 7.0 and <= 10%
3) Change of HbA1c within 3 months prior to registration: <= +/-1%

Key exclusion criteria

1) type 1 diabetes
2) BMI: >= 45
3) patients suspected of pregnancy or pregnant or nursing
4) diabetes insipidus
5) severe liver dysfunction (liver cirrhosis, viral hepatitis, AST: >= 3 times of upper limit)
6) moderate renal dysfunction (eGFR: < 45 ml/min/1.73m2)
7) heart disease (myocardial infarction, unstable angina) or stroke within 3 months
8) considered as inadequate by the investigator

Target sample size

100


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name JUN WADA

Organization

Okayama University Hospital

Division name

nephrology, diabates and endocrinology

Zip code


Address

2-5-1 Shikata-cho, Kita-ku, Okayama

TEL

086-235-7235

Email

junwada@md.okayama-u.ac.jp


Public contact

Name of contact person

1st name
Middle name
Last name DAISUKE OGAWA

Organization

Okayama University Hospital

Division name

nephrology, diabates and endocrinology

Zip code


Address

2-5-1 Shikata-cho, Kita-ku, Okayama

TEL

086-235-7235

Homepage URL


Email

daiogawa@md.okayama-u.ac.jp


Sponsor or person

Institute

Okayama University Hospital
nephrology, diabates and endocrinology

Institute

Department

Personal name



Funding Source

Organization

none

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 10 Month 08 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 27 Day

Date of IRB


Anticipated trial start date

2014 Year 06 Month 24 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 10 Month 08 Day

Last modified on

2017 Year 04 Month 10 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000017886


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name