UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000020185
Receipt number R000023297
Scientific Title Effects of dapagliflozin on renal function in patients with type 2 diabetes [Diamond study-4]
Date of disclosure of the study information 2015/12/14
Last modified on 2019/06/20 13:59:56

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Basic information

Public title

Effects of dapagliflozin on renal function in patients with type 2 diabetes [Diamond study-4]

Acronym

Effects of dapagliflozin on renal function [Diamond study-4]

Scientific Title

Effects of dapagliflozin on renal function in patients with type 2 diabetes [Diamond study-4]

Scientific Title:Acronym

Effects of dapagliflozin on renal function [Diamond study-4]

Region

Japan


Condition

Condition

patients with type 2 diabetes

Classification by specialty

Endocrinology and Metabolism Nephrology

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To evaluate the effects of dapagliflozin on glomerular filtration rate (GFR)

Basic objectives2

Safety,Efficacy

Basic objectives -Others


Trial characteristics_1

Exploratory

Trial characteristics_2


Developmental phase

Not applicable


Assessment

Primary outcomes

Changes from baseline to day 5-9 in GFR evaluated by inulin clearance

Key secondary outcomes

Changes from baseline to month 6-12 in hepatic fat amount


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

70 years-old >

Gender

Male and Female

Key inclusion criteria

Patients who meet all of the following requirements.
1. Patients with type 2 diabetes and HbA1c more than 6.5%
2. Estimated GFR more than 45 mL/min 1.73m2
3. Patients who provide their consent form

Key exclusion criteria

Patients who meet one of the following criteria are ecluded.
1. Patients treated with insulin
2. Patients with unstable angina
3. Patients with severe liver dysfunction (AST >= 100IU/L or ALT >= 100IU/L)
4. Patients with severe renal dysfunction (eGFR < 45 mL/min/1.73m2)
5. Known hypersensitivity to dapagliflozin
6. Patients who are pregnant, possibly pregnant, or nursing
7. A history of traetment with SGLT2 inhibitors including dapagliflozin
8. Patients disqualified by doctor for any reason

Target sample size

15


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Katsuhito Mori

Organization

Osaka City Graduate School of Medicine

Division name

Department of Metabolism, Endocrinology and Molecular Medicine

Zip code


Address

1-4-3, Asahi-machi, Abeno-ku, Osaka

TEL

06-6645-3806

Email

ktmori@med.osaka-cu.ac.jp


Public contact

Name of contact person

1st name
Middle name
Last name Katsuhito Mori

Organization

Osaka City Graduate School of Medicine

Division name

Department of Metabolism, Endocrinology and Molecular Medicine

Zip code


Address

1-4-3, Asahi-machi, Abeno-ku, Osaka

TEL

06-6645-3806

Homepage URL


Email

ktmori@med.osaka-cu.ac.jp


Sponsor or person

Institute

Diamond study group

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

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

Completed

Date of protocol fixation

2015 Year 12 Month 07 Day

Date of IRB

2015 Year 12 Month 07 Day

Anticipated trial start date

2015 Year 12 Month 14 Day

Last follow-up date

2018 Year 12 Month 26 Day

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 14 Day

Last modified on

2019 Year 06 Month 20 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000023297


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name