Treating microalbuminuria over 24 weeks in subjects with or without type 2 diabetes or hypertensio

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 340

Inclusion Criteria

• Age 45 to 80 years
• Persistent urinary albumin:creatinine ratio (UACR) >= 2.5 mg/mmol (~25 mg/g)
• Willing to sign informed consent

Exclusion Criteria

• Diagnosis of type 1 diabetes mellitus
• eGFR < 25 ml/min/1.73m2
• UACR > 3500 mg/g
• Concurrent treatment with SGLT2 inhibitor
• Receiving immunosuppressive therapy within 6 months prior to enrollment
• History of diabetic ketoacidosis
• Active malignancy aside from treated squamous cell or basal cell carcinoma
of the skin.
• Initiation or changes in the dose of interventions in the
renin-angiotensin-aldosterone-system, diuretics, GLP-1 receptor agonists within
6 weeks of screening will not be allowed.
• Any medication, surgical or medical condition which might significantly alter
the absorption, distribution, metabolism, or excretion of medications
including, but not limited to any of the following:
o History of active inflammatory bowel disease within the last six months;
o Major gastrointestinal tract surgery such as gastrectomy, gastroenterostomy,
or bowel resection;
o Gastro-intestinal ulcers and/or gastrointestinal or rectal bleeding within
last six months;
o Pancreatic injury or pancreatitis within the last six months;
o Evidence of hepatic disease as determined by any one of the following: ALT or
AST values exceeding 3x ULN at the screening visit, a history of hepatic
encephalopathy, a history of esophageal varices, or a history of portocaval
shunt;
o Evidence of urinary obstruction or difficulty in voiding at screening
• History of severe hypersensitivity or contraindications to dapagliflozin
• Subjects who, in the assessment of the investigator, may be at risk for
dehydration or volume depletion that may affect the interpretation of efficacy
or safety data
• Participation in any clinical intervention study within 3 months prior to
initial dosing.
• History of drug or alcohol abuse within the 12 months prior to dosing, or
evidence of such abuse as indicated by the laboratory assays conducted during
the screening.
• History of noncompliance to medical regimens or unwillingness to comply with
the study protocol.
• Any surgical or medical condition, which in the opinion of the investigator,
may place the patient at higher risk from his/her participation in the study,
or is likely to prevent the patient from complying with the requirements of the
study or completing the study.
• Pregnancy or breastfeeding

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Change in albuminuria from baseline</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Changes from baseline in:<br /><br>• Systolic / diastolic blood pressure<br /><br>• Body weight<br /><br>• Hba1c<br /><br>• eGFR<br /><br>• Number of patients with >=30%, 40%, 50% reduction in UACR from baseline at<br /><br>week 24</p><br>