Empagliflozin and salt restriction in people with type 2 diabetes and chronic kidney disease

Phase 4

• Conditions: Type 2 diabetes; Chronic kidney disease; Metabolic and Endocrine - Diabetes; Renal and Urogenital - Kidney disease

• Registration Number: ACTRN12621000152820
• Lead Sponsor: St Vincent's Hospital

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2021-02-15
• Last Update Posted: 24 May 2021

Recruitment & Eligibility

• Status: ot yet recruiting
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

Age range: 18 - 75 years
- Diagnosis of type 2 diabetes and HbA1c up to 10%
- Stage 2, 3 or 4 CKD (eGFR 60-89 mL/min/1.73 m2 and urine albumin-to-creatinine ratio >30 mg/g, eGFR 30-59 mL/min/1.73m2 or 15 – 29 mL/min/1.73m2, respectively) at the time of screening, and stable renal function defined as a difference of <30% between two consecutive eGFR in the 3 months before the screening visit
- On stable anti-hypertensive dose of an angiotensin-converting-enzyme (ACE) inhibitor or angiotensin-receptor blocker (ARB) in the one month before the screening visit
- Willing to give written informed consent and willingness to participate to and comply with the study

Exclusion Criteria

- Symptomatic hypotension, systolic blood pressure less than 110 mmHg or hypertension – systolic blood pressure greater than 170 mmHg
- Liver disease (alanine aminotransferase (ALT), aspartate aminotransferase (AST) or alkaline phosphatase (ALP) greater than 3-times normal range limit)
- On haemodialysis or peritoneal dialysis
- Serum potassium of greater than or equal to 6.0 mmol/L
- Type 1 diabetes, diabetes secondary to pancreatic disease, history of diabetic ketoacidosis
- History of neoplastic disease (except for basal cell carcinoma) in the previous 1 year.
- History of recurrent urinary tract infections, genital infections and/or urogenital structural abnormalities
- Overt nephrotic syndrome
- Acute coronary syndrome, stroke, transient ischaemic attack, or other cardiovascular event within 3 months of screening
- Use of the following medications: current treatment with a SGLT2 inhibitor, current or recent (within 3 months) treatment with a glucagon-like peptide-1 (GLP1) agonist, treatment with a glucocorticoid, treatment with a non-steroidal anti-inflammatory drug (at least weekly), investigational new drug within the last 3 months
- Previous bariatric surgery
- Uncontrolled endocrine disorder except type 2 diabetes mellitus
- Current smoker
- Alcohol intake greater than or equal to 14 standard drinks per week
- Women lactating, pregnant or of childbearing potential who are not willing to avoid becoming pregnant during the study
- History of a psychological illness or condition such as to interfere with a person’s ability to understand the requirements of the study.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Change in 24-hour ambulatory blood pressure using a 24-hour ambulatory blood pressure device[Baseline, 4 weeks after intervention commencement]