UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000021177 |
|---|---|
| Receipt number | 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 09:06:33 |
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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
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
research@ibec-jp.com
Sponsor or person
Institute
Nonprofit Organization Hokkaido Health-Science Institute
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000024418
| Research Plan | |
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| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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