Randomized, double-blind, placebo-controlled trial on the effectiveness and safety of dapagliflozin for blood glucose control during glucocorticoid treatment for acute exacerbation COPD

Phase 4

Completed

Conditions: Glucocorticoid induced hyperglycemia
high blood glucose due to glucocorticoid therapy
10018424

Registration Number: NL-OMON41812

Lead Sponsor: Slotervaartziekenhuis

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 46

Inclusion Criteria

- Age >= 18 years and <=100 years at baseline
- Informed consent
- Hospitalization due to AECOPD
- Treatment with >=30mg prednisone daily or equivalent dose of glucocorticoid for AECOPD
- An expected duration of glucocorticoid treatment of 3-14 days at study entry
- Known type 2 diabetes or glucose >= 10 mmol/l at admission

Exclusion Criteria

- Glucocorticoid pulse therapy started >=7 days before study entry
- Need for ICU admission
- Chronic kidney disease stage G3 (glomerular filtration rate <60ml/minute)
- Recurrent genital or urinary tract infection
- Current use of any SGLT-2 inhibiting agent
- Suspected volume depletion
- Congestive heart failure functional classification NYHA class IV/IV or instable heart failure
- Acute stroke within 2 months before inclusion.
- Recent cardiovascular event: acute coronary syndrome, hospitalisation for unstable angina or coronary revascularisation within 2 months before inclusion
- Suspected liver disease, confirmed by AST/ALT > 3x ULN or bilirubin >2.0mg/dl (34.2 µmol/l) or serologically proven infection with hepatitis B or hepatitis C
- Pregnancy or breast feeding

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Effectiveness: The difference in mean percentage time spent within glucose<br /><br>target range on 2nd till 7th day of treatment, between the dapagliflozin group<br /><br>and the control group as measured by subcutaneous continuous glucose monitor.<br /><br>Target range is defined as random glucose 4-10 mmol/l according to ADA<br /><br>guidelines for non-critically ill inpatients (20).<br /><br>Safety: Incidence rate of hypoglycaemic events per patient-day. A hypoglycaemic<br /><br>event is defined according to Whipple*s criteria (i.e. symptoms known or likely<br /><br>to be caused by hypoglycaemia, interstitial glucose <= 3.9 mmol/l continuing<br /><br>until the interstitial glucose is >3.9 mmol/l, relief of symptoms when glucose<br /><br>is raised to normal).</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>1. Patient satisfaction measured by Diabetes Treatment Satisfaction<br /><br>Questionnaire for inpatients (DTSP-IP) (21) specifically directed at glucose<br /><br>lowering treatment.<br /><br>2. Clinical outcomes: duration of hospitalisation, need for intensification of<br /><br>treatment for AECOPD, change in body weight and blood pressure during<br /><br>investigational treatment.<br /><br>3. Other parameters of glucose control:<br /><br>- Glucose variability by mean amplitude of glycaemic excursion (MAGE)<br /><br>- Total daily dose of insulin<br /><br>- Mean daily glucose concentration<br /><br>- Mean percentage time spent within glucose target range from start till end of<br /><br>treatment<br /><br>4. Safety: incidence rate of asymptomatic hypoglycaemia, incidence of genital<br /><br>infections and urinary tract infections, incidence of other adverse events.</p><br>