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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000025102
Receipt No. 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 2018/06/04

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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 ratio of the number of patients presenting albuminuria category shift
Improvement test
The shift to the better category
Prevention test
No shift or shift to the worse category
Categories
category 1 (less than 30 mg/g・Cr)
category 2 (from 30 to 299 mg/g・Cr)
category 3 (over 300 mg/g・Cr)
(2) Magnitude of changes of eGFR during 2-years experimental period
(3)The ratio of the number of patients presenting eGFR category shift
Improvement test
The shift to the better category
Prevention test
No shift or shift to the 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 magnitude of changes of urinary kidney injury molecule-1 (KIM-1) from the baseline after 2 years observation
(5) The magnitude of changes of plasma aldosterone concentration, plasma NT-proBNP concentration, serum FGF23 concentration and plasma alpha-Klotho concentration from the baseline after 2 years observation
(6) The composite endpoint, which is defined as the cardiovascular (CV) death or the hospitalization for CV events in 2 years observation
(7) The composite endpoint, which is defined as CV death or the hospitalization for HF in 2 years observation
(8) The onset of CV events in 2 years observation
(9) The hospitalization for CV events in 2 years observation
(10) The hospitalization for HF in 2 years observation
(11) The death for all cause in 2 years observation
(12) The hospitalization for all cause in 2 years observation
(13) The additional change of prescription for HF in 2 years observation
(14) The magnitude of changes of echocardiographic parameters, including left ventricular end-diastolic and end-systolic dimensions, left atrial volume index, left atrial dimension, ejection fraction (15) and fractional shortening (16)
(17) The category of New York Heart Association (NYHA) classification in 2 years observation

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 446

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Masafumi Kitakaze
Organization National Cerebral and Cardiovascular Center
Division name Department of Clinical Medicine and Development
Zip code
Address 5-7-1 Fujishiro-dai, Suita, Osaka, 5658565, Japan
TEL 06-6833-5012
Email kitakaze@ncvc.go.jp

Public contact
Name of contact person
1st name
Middle name
Last name Fumiki Yoshihara
Organization National Cerebral and Cardiovascular Center
Division name Division of Hypertension and Nephrology
Zip code
Address 5-7-1 Fujishiro-dai, Suita, Osaka, 5658565, Japan
TEL 06-6833-5012
Homepage URL
Email fyoshi@ncvc.go.jp

Sponsor
Institute Department of Clinical Medicine and Development, National Cerebral and Cardiovascular Center, 5-7-1 Fujishiro-dai, Suita, Osaka, 5658565, Japan
Institute
Department

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
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
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 Enrolling by invitation
Date of protocol fixation
2016 Year 09 Month 06 Day
Date of IRB
Anticipated trial start date
2017 Year 03 Month 01 Day
Last follow-up date
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
2018 Year 06 Month 04 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000028509

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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