Hyperglycemia Steroid-induced Clinical Trial
Official title:
Randomized, Double-blind, Placebo-controlled Trial on the Effectiveness and Safety of Dapagliflozin for Blood Glucose Control During Glucocorticoid Treatment for Acute Exacerbation COPD
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.
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. However, sliding scale insulin is patient unfriendly, does not
reduce glycaemic excursion nor glycaemic variability. In contrast, pharmacologic inhibition
of the sodium glucose transporter-2 (SGLT-2) can be given as an oral agent and is likely to
result in better glucose control with lower risk of hypoglycaemia Objective: glucose control
and safety (risk of hypoglycaemia). Secondary objectives are patient satisfaction, other
safety outcomes and other parameters of glucose control Study design: Double-blind placebo
controlled intervention study Study population: Patients hospitalized for an exacerbation of
chronic obstructive lung disease who are treated with high dose glucocorticoids.
Intervention: One group receives once daily a 10mg tablet of dapagliflozin and the other
group receives once daily a placebo tablet as add on to their prestudy glucose-lowering
medication. Both groups will be treated with glucose lowering escape medication if required.
Main study parameters/endpoints: Glucose control is measured as the average time spent within
target range in each patient. Safety is measured as the incidence rate of hypoglycaemia
during study follow-up.
Nature and extent of the burden and risks associated with participation, benefit and group
relatedness: The burden of participation consists of the extra capillary glucose measurements
that will be done 3-4 times daily and wearing a coin size glucose sensor. Furthermore,
patients have to fill out a treatment satisfaction questionnaire. There will be no extra site
visits for participants.
Dapagliflozin (experimental group) carries a risk of hypoglycaemia, especially for patient
who have concomitant therapy with insulin or sulfonylurea derivatives. Patients will be
instructed to anticipate, and if required dosing of glucose lowering therapy will be
adjusted. Furthermore, dapagliflozin carries an increased risk of urogenital infections,
increased haematocrit and LDL cholesterol.
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