DAPPER study

Phase 4

• Conditions: Type 2 Diabetes Mellitus patients with Chronic Heart Failure; Type 2 Diabetes Mellitus patients

• Registration Number: JPRN-jRCTs051180135
• Lead Sponsor: Yoshihara Fumiki

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2019-03-18
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 288

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
3. 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

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The changes in the urine albumin-to-creatinine ratio (UACR) from the baseline after a 2-year observation