UMIN-CTR Clinical Trial

Public title

Yokohama Add-on Inhibitory efficacy of Dapagliflozin on Albuminuria in Japanese patients
with type 2 diabetes study

Acronym

Yokohama Add-on Inhibitory efficacy of Dapagliflozin on Albuminuria in Japanese patients
with type 2 diabetes study
(Y-AIDA study)

Scientific Title

Yokohama Add-on Inhibitory efficacy of Dapagliflozin on Albuminuria in Japanese patients
with type 2 diabetes study

Scientific Title:Acronym

Yokohama Add-on Inhibitory efficacy of Dapagliflozin on Albuminuria in Japanese patients
with type 2 diabetes study
(Y-AIDA study)

Region

Japan

Condition

type 2 diabetes with albuminuria

Classification by specialty

Endocrinology and Metabolism

Nephrology

Classification by malignancy

Others

Genomic information

NO

Narrative objectives1

The study will examine beneficial effects of SGLT2 inhibitor dapagliflozinon on urinary albumin excretion, glucose metabolism, oxidative stress and home blood pressure in T2DM patients with albuminuria.

Basic objectives2

Safety,Efficacy

Basic objectives -Others

Trial characteristics_1

Confirmatory

Trial characteristics_2

Pragmatic

Developmental phase

Primary outcomes

The primary endpoint was the change in the natural logarithm of the UACR (mg/g-Cr) of the spot urine from the baseline (0 wks before treatment) to the endpoint (after 24 wks of protocol treatment)

Key secondary outcomes

Secondary endpoints were change from the baseline (0 wks before treatment) to the endpoint (after 24 wks of protocol treatment). Several measurements will be performed at 8 wks and 16 wks of protocol treatment for additional estimation.
Efficacy endpoints:
(1)Physical findings
Body weight,BMI,clinic BP and PR
(2)Urine analysis
UPCR, U-Na/Cr, urine L-FABP/Cr, urine Col-IV/Cr, urine 8-OHdG/Cr
(3)Glucose metabolism
Fasting glucose, bA1c
(4)Renal function
Estimated glomerular filtration(eGFR) calculated using a revised equation for the Japanese population(27).
The value of eGFR(mL/min/1.73 m2) = 194 X serum creatinine-1.094 X Age-0.287 X 0.739(if female).
(5)Lipid metabolism
LDL-cholesterol,HDL-cholesterol, total cholesterol, triglyceride, FFA
(6)Oxidative stress and reduction power pentosidine, derivatives of reactive oxidative metabolites (d-ROMs),biological anti-oxidative potential (BAP)
(7)Home BP analysis Home BP (morning, evening), day-by-day home BP variability, nighttime home BP, day-by-day nighttime home BP variability
(8)Other measurement
Dosage of dapagliflozin, achievement of target HbA1c levels (HbA1c <7.0%),transition of diabetic nephropathy stage (percentage of improvement, no change or worsening)renal composite outcome
Safety outcomes:
Representative adverse events which occur during the protocol therapy perid from the baseline (0 wks before treatment) to the endpoint (after 24 wks of protocol treatment).

Study type

Interventional

Basic design

Single arm

Randomization

Non-randomized

Randomization unit

Blinding

Open -no one is blinded

Control

Uncontrolled

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

No. of arms

1

Purpose of intervention

Treatment

Type of intervention

Medicine

Interventions/Control_1

Dapagliflozin therapy by oral administration of once-daily Forxiga 5 mg tablet will be performed for 24 weeks of protocol therapy period. To achieve the target HbA1c < 7.0% (NGSP), the dose of dapagliflozin may be increased to 10 mg daily (Forxiga 10 mg tablet), as needed.

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

Age-lower limit

20

years-old

<=

Age-upper limit

80

years-old

>

Gender

Male and Female

Key inclusion criteria

(1)Aged between 20 and < 80 years of age on day of signing informed consent (male/female)
(2)Diagnosis of T2DM
(3)CKD of G1-to-G3a categories (eGFR >=45 ml/min/1.73 m2) and A2-to-A3 categories (urine albumin-to-creatinine ratio, UACR >=30 mg/g-Cr)
(4)Inadequate glycemic control, defined as HbA1c >=7.0% and <=10.0% (NGSP)
(5)Written informed consent

Key exclusion criteria

(1)Patients who were planning a baby, pregnant, or breastfeeding women.
(2)Significantly elevated creatinine kinase(CK) level (CK > 765U/L)
(3)Severe hepatic insufficiency and/or significant abnormal liver function(AST > 96U/L and/or ALT > 135U/L)
(4)New York Heart Association class IV congestive heart failure or acute congestive heart failure
(5)A history of diabetic ketoacidosis, diabetic coma or pre coma within the past 6 months prior to the screening visit
(6)Severe infection
(7)Pre or post surgery
(8)Serious trauma
(9)Known hypersensitivity to dapagliflozin
(10)On-going treatment with SGLT2 inhibitors or a history of treatment with SGLT2 inhibitors within 1month
(11)Patients judged by the investigator to be ineligible for some other reason

Target sample size

80

Name of lead principal investigator

1st name	Kouichi
Middle name
Last name	Tamura

Organization

Yokohama City University Hospital

Division name

Department of Medical Science and Cardiorenal Medicine

Zip code

236-0004

Address

3-9 Fukuura, Kanazawa-ku, Yokohama City, 236-0004, Japan

TEL

045-787-2635

Email

tamukou@yokohama-cu.ac.jp

Name of contact person

1st name	Kouichi
Middle name
Last name	Tamura

Organization

Yokohama City University Hospital

Division name

Department of Medical Science and Cardiorenal Medicine

Zip code

236-0004

Address

3-9 Fukuura, Kanazawa-ku, Yokohama City, 236-0004, Japan

TEL

045-787-2635

Homepage URL

Email

tamukou@yokohama-cu.ac.jp

Institute

Yokohama City University Hospital

Institute

Department

Personal name

Organization

AstraZeneca and Ono Pharmaceutical co. LTD

Organization

Division

Category of Funding Organization

Profit organization

Nationality of Funding Organization

Japan

Co-sponsor

Name of secondary funder(s)

Organization

Yokohama City University Ethics Committee

Address

3-9 Fukuura, Kanazawa-ku, Yokohama City, 236-0004, Japan

Tel

045-370-7629

Email

nextjim1@yokohama-cu.ac.jp

Secondary IDs

YES

Study ID_1

VT AZ MEDI_ESR-14-10420

Org. issuing International ID_1

AstraZeneca

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

横浜市立大学附属病院（神奈川県）
横浜市立大学附属市民総合医療センター（神奈川県）
済生会横浜市南部病院（神奈川県）
横浜南共済病院（神奈川県）

Date of disclosure of the study information

2015

Year

09

Month

07

Day

URL releasing protocol

Publication of results

Published

URL related to results and publications

Number of participants that the trial has enrolled

86

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

Recruitment status

Completed

Date of protocol fixation

2015

Year

02

Month

11

Day

Date of IRB

2015

Year

03

Month

06

Day

Anticipated trial start date

2015

Year

09

Month

01

Day

Last follow-up date

2018

Year

08

Month

01

Day

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other related information

Registered date

2015

Year

09

Month

07

Day

Last modified on

2019

Year

07

Month

26

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000021899