Glucose Control During Glucocorticoid Therapy in Acute Exacerbation of Chronic Obstructive Pulmon… (NCT02253121) | Clinical Trial Compass
CompletedPhase 4
Glucose Control During Glucocorticoid Therapy in Acute Exacerbation of Chronic Obstructive Pulmonary Disease
Netherlands46 participantsStarted 2015-02
Plain-language 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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Glucose control
Timeframe: 2nd till 7th day of treatment
2
Risk of hypoglycemia
Timeframe: Randomisation till end of study (expected duration of 12 days)