Glucose Control During Glucocorticoid Therapy in Acute Exacerbation of Chronic Obstructive Pulmonary Disease

• Status: Completed
• Trial end date: 2017-05-01
• Target enrollment: 0
• Participant gender: All

Summary

Purpose of this study is to treat glucocorticoid induced hyperglycemia due to glucocorticoid pulse therapy in a efficacious, safe and convenient way. Patients with acute exacerbation of COPD treated with glucocorticoid pulse therapy and at high risk for glucocorticoid induced hyperglycemia (defined as known type 2 DM or glucose > 10mmol/l at admission) will be randomized to treatment of dapagliflozin or placebo orally, once daily.

Percentage of time within glucose target range (3,9-10 mmol/l) and incidence rate of hypoglycemia will be compared between dapagliflozin group and placebo group.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Slotervaart Hospital
• Collaborators: AstraZeneca; Isala; Spaarne Gasthuis; Spaarne Ziekenhuis
• Treatments: Dapagliflozin; Glucocorticoids; Insulin; Insulin, Globin Zinc

Criteria

Inclusion Criteria:

• 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:

• High dose glucocorticoid treatment 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