GluCon-COPD
Randomized, Double-blind, Placebo-controlled Trial on the Effectiveness and Safety of Dapagliflozin for Blood Glucose Control During Glucocorticoid Treatment for Acute Exacerbation COPD
Sponsor study identifier
Secondary identifiers
EUDRACT_NUMBER
NIH
interventional
46
1 country
4
Study Start
February 2015
Actual (reported)Primary Completion
March 2016
Actual (reported)Study Completion
May 2017
Actual (reported)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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
May 2017
Actual (reported)Click on a node to explore related trials.
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
September 22, 2014
Actual (reported)October 1, 2014
Actual (reported)February 2015
Actual (reported)March 2016
Actual (reported)May 2017
Actual (reported)Glucose control
% time within target range (3.9-10 mmol/l)
2nd till 7th day of treatment
Risk of hypoglycemia
Incidence rate of hypoglycaemic events
Randomisation till end of study (expected duration of 12 days)
Patient satisfaction
During hospital stay (expected average of 9 days)
Clinical outcomes
During hospital stay (expected average of 9 days)
Safety
Randomisation till end of study (expected duration of 12 days)
Treatment with dapagliflozin 10mg once daily orally. Treatment will start as soon as possible after initation of glucocorticoid pulse therapy for acute exacerbation COPD and will end when pulse therapy is finished (expected duration 10-14 days). In case of persistent glucose levels \> 12 mmol/l, subjects will receive escape treatment with sliding scale insulin.
Treatment with placebo once daily orally. Treatment will start as soon as possible after initation of glucocorticoid pulse therapy for acute exacerbation COPD and will end when pulse therapy is finished (expected duration 10-14 days). In case of persistent glucose levels \> 12 mmol/l, subjects will receive escape treatment with sliding scale insulin.
Dapagliflozin 10mg during glucocorticoid therapy for acute exacerbation COPD
Sliding scale insulin with short acting insulin based on current glucose levels
Slotervaart Hospital
Amsterdam, 1066 EC, Netherlands
OLVG West
Amsterdam, Netherlands
Spaarne Ziekenhuis
Hoofddorp, Netherlands
Isala
Zwolle, Netherlands
Victor Gerdes, MD, PhD
Slotervaart Hospital
46 participants (actual enrollment reported by the registry).
First Submitted
September 22, 2014
First Posted
October 1, 2014
Study Start
February 2015
Actual (reported)Effect of Dapagliflozin on Glycemic Variability
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
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Primary Completion
March 2016
Actual (reported)Study Completion
May 2017
Actual (reported)Last Updated
May 22, 2018
Record last verified: 2018-05
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Source: ClinicalTrials.gov.
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