Status:
COMPLETED
Glucose Control During Glucocorticoid Therapy in Acute Exacerbation of Chronic Obstructive Pulmonary Disease
Lead Sponsor:
Slotervaart Hospital
Collaborating Sponsors:
AstraZeneca
Isala
Conditions:
Hyperglycemia Steroid-induced
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief 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 w...
Detailed Description
Rationale: Patients hospitalized for COPD exacerbation treated with high dose glucocorticoids, frequently develop hyperglycaemia. Currently, sliding scale insulin is often used to bridge such episodes...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
February 1 2015
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2017
Estimated Enrollment :
46 Patients enrolled
Trial Details
Trial ID
NCT02253121
Start Date
February 1 2015
End Date
May 1 2017
Last Update
May 22 2018
Active Locations (4)
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1
Slotervaart Hospital
Amsterdam, Netherlands, 1066 EC
2
OLVG West
Amsterdam, Netherlands
3
Spaarne Ziekenhuis
Hoofddorp, Netherlands
4
Isala
Zwolle, Netherlands