NCT02253121

Glucose Control During Glucocorticoid Therapy in Acute Exacerbation of Chronic Obstructive Pulmonary Disease

Randomized, Double-blind, Placebo-controlled Trial on the Effectiveness and Safety of Dapagliflozin for Blood Glucose Control During Glucocorticoid Treatment for Acute Exacerbation COPD

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 46 (actual)
• Sponsor: Slotervaart Hospital · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

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. 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.

Conditions

• Hyperglycemia Steroid-induced

Interventions

Type	Name	Description
DRUG	Dapagliflozin	Dapagliflozin 10mg during glucocorticoid therapy for acute exacerbation COPD
DRUG	Sliding scale insulin	Sliding scale insulin with short acting insulin based on current glucose levels

Timeline

• Start date: 2015-02-01
• Primary completion: 2016-03-01
• Completion: 2017-05-01
• First posted: 2014-10-01
• Last updated: 2018-05-22

Locations

4 sites across 1 country: Netherlands