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

Conditions

• Hyperglycemia Steroid-induced

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

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

Study Details

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.

Key Dates

Start date

Feb 28, 2015

Status verified

May 2018

Primary completion

Mar 31, 2016

Completion

May 31, 2017

Study Design

Enrollment

46 participants (actual)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: Dapagliflozin + sliding scale insulin.
  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.
• Placebo Comparator: Placebo + 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.

Primary Outcome Measure

Glucose control [ Time Frame: 2nd till 7th day of treatment ]