UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000025102 |
|---|---|
| Receipt number | R000028509 |
| Scientific Title | An exploratory study of dapagliflozin for the attenuation of albuminuria in patients with heart failure and type 2 diabetes mellitus |
| Date of disclosure of the study information | 2016/12/15 |
| Last modified on | 2022/06/07 10:26:50 |
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Basic information
Public title
An exploratory study of dapagliflozin for the attenuation of albuminuria in patients with heart failure and type 2 diabetes mellitus
Acronym
DAPPER study
Scientific Title
An exploratory study of dapagliflozin for the attenuation of albuminuria in patients with heart failure and type 2 diabetes mellitus
Scientific Title:Acronym
DAPPER study
Region
| Japan |
Condition
Condition
Type 2 Diabetes Mellitus patients with Chronic Heart Failure
Classification by specialty
| Cardiology | Endocrinology and Metabolism |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To elucidate whether dapagliflozin improves the magnitude of urinary albumin creatinine ratio from the baseline in Type 2 Diabetes Mellitus patients with chronic heart failure compared with other anti-diabetic agents except sodium-dependent glucose transporter-2 inhibitors after 2 years observation
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The magnitude of the change in urinary albumin creatinine ratio after 2 years observation from the baseline
Key secondary outcomes
(1) The proportion of the number of patients presenting with an albuminuria category shift in each group (dapagliflozin group and control group)
Improvement test
A shift to a better category
Prevention test
No shift to a worse category
Categories
Category 1 (less than 30 mg/g Cr)
Category 2 (from 30 to 299 mg/g Cr)
Category 3 (more than 300 mg/g Cr)
(2) Changes of eGFR during a 2-year period
(3) The proportion of the number of patients presenting with an eGFR category shift in each group
Improvement test
A shift to a better category
Prevention test
No shift or a shift to a worse category
Categories
Category 1 (more than 90 ml/min/1.73m2)
Category 2 (from 89 to 60 ml/min/1.73m2)
Category 3 (from 59 to 45 ml/min/1.73m2)
(4) The changes of urinary kidney injury molecule-1 (KIM-1) from the baseline after a 2-year observation
(5) The changes in the plasma aldosterone concentration, plasma NT-pro BNP concentration, serum FGF23 concentration, and plasma alpha-Klotho concentration from the baseline after a 2-year observation
(6) The composite endpoint, which is defined as CV death or hospitalization for CV events in a 2-year observation
(7) The composite endpoint, which is defined as CV death or the hospitalization for HF in a 2-year observation
(8) The onset of CV events in a 2-year observation
(9) Hospitalization for CV events in a 2-year observation
(10) Hospitalization for HF in a 2-year observation
(11) Death from all causes in a 2-year observation
(12) Hospitalization for all causes in a 2-year observation
(13) An additional change in prescriptions for HF in a 2-year observation
(14) The changes in echocardiographic parameters, including left ventricular end-diastolic and end-systolic dimensions, the left atrial volume index, left atrial dimension, (15) ejection fraction, and (16) fractional shortening from the baseline after a 2-year observation
(17) The category of the New York Heart Association (NYHA) classification in a 2-year observation
etc.
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Medicine |
Interventions/Control_1
dapagliflozin, 5 mg or 10 mg, 2 years observation
Interventions/Control_2
anti-diabetic drugs except for SGLT-2 inhibitors, 2 years observation
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
| 85 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1) Patients with type 2 diabetes at 20 years-old or older and less than or equal to 85 years-old at the time of informed consent
2) Patients necessary to start the treatment using anti-diabetic agent(s) or to change the anti-diabetic agent(s)
3) Patients with plasma HbA1C levels < 10% with or without anti-diabetic agent(s)
4) Patients who fall into any of the following items are defined as those with chronic heart failure:
1. NYHA Functional Class II, III or IV within 3 months before informed consent;
2. Plasma BNP levels of 100 pg/mL or plasma NT-pro BNP levels of 400 pg/mL within 3 months before informed consent; or previous diagnosis of heart failure that was treated including drug therapy.
5) The value of eGFR should be more than 45 ml/min/1.73m2
6) Agreement of written informed consent
Key exclusion criteria
1) Patients with insulin treatment
2) Patients with an allergic history of dapagliflozin
3) Patients with a history of severe diabetic ketoacidosis, diabetic coma or pre-coma
4) Patients using mechanical circulatory support devices
5) Patients waiting for heart transplant
6) Patients waiting for cardiac surgery
7) Patients who may easily show dehydration, including a history of dehydration, highly frequent change of diuretics, extreme thinness
8) Patients with hepatic dysfunction with AST or ALT 3-fold of upper limit of normal (ULN) at screening (However, if increased AST or ALT is determined to be attributable to cardiac diseases, patients do not meet this exclusion criterion as long as total bilirubin levels are < 3.0 mg/dL.)
9) Patients with bilateral renal artery stenosis or renal artery stenosis in a solitary kidney
10) Patients in a serious clinical condition and who are expected to live for < 3 years
11) Patients with possible alcohol or drug abuse
12) Patients who are pregnant or possibly pregnant
13) Patients with breast feeding
14) Patients who have been enrolled in other clinical studies at the same time with this study (excluding observational studies such as registry studies)
15) Patients who are judged by the investigator or subinvestigators to be not suitable for participation in the study
Target sample size
288
Research contact person
Name of lead principal investigator
| 1st name | Fumiki |
| Middle name | |
| Last name | Yoshihara |
Organization
National Cerebral and Cardiovascular Center
Division name
Division of Nephrology
Zip code
5648565
Address
6-1, Kishibeshinmachi, Suita, Osaka
TEL
0661701070
fyoshi@ncvc.go.jp
Public contact
Name of contact person
| 1st name | Fumiki |
| Middle name | |
| Last name | Yoshihara |
Organization
National Cerebral and Cardiovascular Center
Division name
Division of Nephrology
Zip code
5648565
Address
6-1, Kishibeshinmachi, Suita, Osaka
TEL
0661701070
Homepage URL
fyoshi@ncvc.go.jp
Sponsor or person
Institute
Department of Clinical Medicine and Development, National Cerebral and Cardiovascular Center, 5-7-1 Fujishiro-dai, Suita, Osaka, 5658565, Japan
Institute
Department
Personal name
Funding Source
Organization
Astra Zeneka KK and Ono Pharmaceutical Co., Ltd.
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Hyogo College Of Medicine
Address
1-1, Mukogawacho, Nishinomiya, Hyogo
Tel
0798-45-6066
rinken@hyo-med.ac.jp
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
| 2016 | Year | 12 | Month | 15 | 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
No longer recruiting
Date of protocol fixation
| 2016 | Year | 09 | Month | 06 | Day |
Date of IRB
| 2016 | Year | 10 | Month | 25 | Day |
Anticipated trial start date
| 2017 | Year | 03 | Month | 01 | Day |
Last follow-up date
| 2022 | Year | 03 | Month | 31 | 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 | 12 | Month | 01 | Day |
Last modified on
| 2022 | Year | 06 | Month | 07 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000028509
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