UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status Terminated
Unique ID issued by UMIN UMIN000021177
Receipt No. R000024418
Scientific Title Renin Observed with Added Dapagliflozin - an Evaluation under Unexceptional RAS Inhibitor Administration.
Date of disclosure of the study information 2016/04/01
Last modified on 2019/04/16

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


Basic information
Public title Renin Observed with Added Dapagliflozin - an Evaluation under Unexceptional RAS Inhibitor Administration.
Acronym Effect of Dapagliflozin on Renin-Angiotensin-Aldosterone System(ROAD-EURASIA)
Scientific Title Renin Observed with Added Dapagliflozin - an Evaluation under Unexceptional RAS Inhibitor Administration.
Scientific Title:Acronym Effect of Dapagliflozin on Renin-Angiotensin-Aldosterone System(ROAD-EURASIA)
Region
Japan

Condition
Condition Adults with type 2 diabetes
Classification by specialty
Medicine in general Endocrinology and Metabolism
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 The objective of the study is to elucidate the effect of dapagliflozin on RAA system of Type 2 diabetes patients complicated with hypertension.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Pragmatic
Developmental phase Phase IV

Assessment
Primary outcomes plasma renin activity (PRA)
Key secondary outcomes Group comparison of the following parameters before and after treatment
1) Physical examination
Body weight, BMI, blood pressure, and pulse rate
2) Electrocardiogram
3) Hematology
WBC, RBC, Hb, Ht, PLT
4) Biochemistry
TC, HDL-C, TG, Cys-C, eGFRcys, Cr, BUN, UA,Na, K, Cl, HbA1c, and fasting blood sugar
5) Plasma aldosterone concentration (PAC)
6) AVP, BNP
7) Urinalysis
Urine protein, urine sugar, specific gravity urine, urine sodium, urine potassium and urine chromium
8) Adverse events

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Open -no one is blinded
Control Active
Stratification YES
Dynamic allocation YES
Institution consideration Institution is not considered as adjustment factor.
Blocking NO
Concealment Central registration

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 Treatment at obtaining consent is continued and 5 mg of dapagliflozin is orally administered once daily. In addition to everyday water intake, water or tea is taken in amount of 100 mL after each meal and before going to bed, i.e., 400 mL/day in total.
Interventions/Control_2 Treatment at obtaining consent is continued.
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) Type 2 diabetic patients
2) Patients with HbA1c of 6.5% to 8.4%
3) Patients whose HbA1c is within 1% during the last 3 months
4) Hypertension patients who are treated with renin-angiotensin system inhibitor (referred as RAS inhibitor) from 8 weeks before screening or earlier (concomitant use of a direct renin inhibitor, an angiotensin-converting enzyme inhibitor or an angiotensin II receptor antagonist is to be prohibited)
5) Patients with BMI of 22.0 kg/m2 or higher
6) Patients from 20 years old but less than 75 years old at obtaining consent
7) Patients with eGFRcys of 45 mL/min/1.73m2 or higher
8) Patients having no dosing history of SGLT2 inhibitor within 4 months
Key exclusion criteria 1. Type 1 diabetes, 2. Class III hypertension (SBP180 mmHg or more and/or DBP110 mmHg or more), 3. Clinical history (CH) of hypersensitivity to SGLT2 inhibitors, 4. Severe ketosis, diabetic coma or precoma, 5. Severe infectious disease, pre/post-surgery or serious trauma, 6. Severe renal dysfunction or end-stage renal failure under dialysis, 7. Pulmonary embolus or severe pulmonary function impediment, 8. Pituitary or adrenal gland dysfunction, 9. Status of dystrophy/starvation, irregular meal intake, dietary intake deficiency or hyposthenia. 10, Excessive alcohol intake. 11. CH of the following severe liver dysfunctions: AST and/or ALT100 U/L or more, total bilirubin 2.0 mg/dL (34.2 micromol/L)or more, 12. Dehydrated patients including those with non-functioning GIT such as diarrhea, vomiting or malignancy, 13. Complicated with malignancies, 14. Pregnant/ possible pregnant, breast-feeding, 15. Inappropriate patients for study participation judged by principal or clinical investigator, 16. Dosing of direct renin inhibitor, 17. Combined use of angiotensin-convertase inhibitor/ angiotensin II receptor antagonists, 18. Dosing of beta- or alpha,beta-blocking agent or its dosing history (DH) within 4 months, 19. Dosing of diuretic drugs or its DH within 2 months
Target sample size 140

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Mitsuhiko Noda
Organization Saitama Medical University Hospital
Division name Department of Endocrinology and Diabetes
Zip code
Address Morohongo 38, Moroyamamachi, Iruma-gun, Saitama Japan,
TEL 049-276-1111
Email noda_m@saitama-med.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Naohide Noumi
Organization IBEC Co., Ltd.
Division name CEO Office
Zip code
Address Tanaka Jun Build. 3F, 2-5-14 Teradacho, Tennohji-ku, Osaka-shi, 5430045, Japan
TEL 06-7172-1751
Homepage URL
Email research@ibec-jp.com

Sponsor
Institute Nonprofit Organization Hokkaido Health-Science Institute
Institute
Department

Funding Source
Organization AstraZeneca K.K.
Ono Pharmaceutical Co., Ltd.
Organization
Division
Category of Funding Organization Profit organization
Nationality of Funding Organization Japan

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 天理よろづ相談所病院(奈良県)
国立病院機構京都医療センター(京都府)
埼玉医科大学病院(埼玉県)
関西医科大学附属病院(大阪府)
日本赤十字社大森赤十字病院(東京都)
社会医療法人社団カレスサッポロ北光記念クリニック(北海道)
自治医科大学附属さいたま医療センター(埼玉県)
日本赤十字社小川赤十字病院(東京都)

Other administrative information
Date of disclosure of the study information
2016 Year 04 Month 01 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 114
Results
The study has been ceased to be registered to the UMIN because specific categories of clinical research are changed to be registered in the jRCT due to Clinical Research Law enforcement.
Results date posted
2019 Year 03 Month 27 Day
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 Terminated
Date of protocol fixation
2016 Year 02 Month 16 Day
Date of IRB
2016 Year 05 Month 02 Day
Anticipated trial start date
2016 Year 07 Month 04 Day
Last follow-up date
2019 Year 02 Month 06 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2016 Year 02 Month 24 Day
Last modified on
2019 Year 04 Month 16 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000024418

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.