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

NCT02253121 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 46

Last updated 2018-05-22

No results posted yet for this study

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.

Conditions

  • Hyperglycemia Steroid-induced

Interventions

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

Sponsors & Collaborators

  • AstraZeneca

    collaborator INDUSTRY

  • Isala

    collaborator OTHER

  • Spaarne Gasthuis

    collaborator OTHER

  • Slotervaart Hospital

    lead OTHER

Principal Investigators

  • Victor Gerdes, MD, PhD · Slotervaart Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-02-28
Primary Completion
2016-03-31
Completion
2017-05-31

Countries

  • Netherlands

Study Locations

More Related Trials

Entities

Drugs
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02253121 on ClinicalTrials.gov