Glucose Control during glucocorticoid therapy in acute exacerbation of chronic obstructive pulmonary disease

• Conditions: Glucocorticoid induced hyperglycemia; Therapeutic area: Body processes [G] - Metabolic Phenomena [G03]

• Registration Number: EUCTR2014-002370-36-NL
• Lead Sponsor: Slotervaart Hospital

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2015-02-03
• Last Update Posted: 16 March 2015

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: Not specified

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

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 23
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 23

Exclusion Criteria

-Maintenance treatment with systemic glucocorticoids or 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

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified