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

NCT02253121 | Completed Phase 4

• 2 other identifiers: NL49690.048.142014-001877-15
• Study Type: interventional
• Target: 46
• Locations: 1 country
• Sites: 4

Brief 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

Keywords

COPD; acute exacerbation; glucocorticoid therapy; hyperglycemia

Outcome Measures

Primary Outcomes (2)

• 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)

Secondary Outcomes (3)

• 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)

Study Arms (2)

Dapagliflozin + sliding scale insulin.

EXPERIMENTAL

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.

Drug: Dapagliflozin; Drug: Sliding scale insulin

Placebo + sliding scale insulin

PLACEBO COMPARATOR

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.

Drug: Sliding scale insulin

Interventions

Dapagliflozin DRUG

Dapagliflozin 10mg during glucocorticoid therapy for acute exacerbation COPD

Also known as: Forxiga

Dapagliflozin + sliding scale insulin.

Sliding scale insulin DRUG

Sliding scale insulin with short acting insulin based on current glucose levels

Also known as: Supplemental insulin

Dapagliflozin + sliding scale insulin.; Placebo + sliding scale insulin

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Informed consent
• Hospitalization due to AECOPD
• Treatment with ≥30mg prednisone daily or equivalent dose of glucocorticoid for AECOPD
• An expected duration of glucocorticoid treatment of 3-14 days at study entry
• Known type 2 diabetes or glucose ≥ 10 mmol/l at admission

You may not qualify if:

• High dose glucocorticoid treatment started ≥7 days before study entry
• Need for ICU admission
• Chronic kidney disease stage G3 (glomerular filtration rate \<60ml/minute)
• Recurrent genital or urinary tract infection
• Current use of any SGLT-2 inhibiting agent
• Suspected volume depletion
• Congestive heart failure functional classification NYHA class IV/IV or instable heart failure
• Suspected liver disease, confirmed by AST/ALT \> 3x ULN or bilirubin \>2.0mg/dl (34.2 μmol/l) or serologically proven infection with hepatitis B or hepatitis C
• Pregnancy or breast feeding

Sponsors & Collaborators

• Slotervaart Hospital: lead
• AstraZeneca: collaborator
• Isala: collaborator
• Spaarne Gasthuis: collaborator

Study Sites (4)

Slotervaart Hospital

Amsterdam, 1066 EC, Netherlands

Location

OLVG West

Amsterdam, Netherlands

Location

Spaarne Ziekenhuis

Hoofddorp, Netherlands

Location

Isala

Zwolle, Netherlands

Location

Related Links

• Related Info

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive; Hyperglycemia

Interventions

dapagliflozin

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Officials

• Victor Gerdes, MD, PhD

  Slotervaart Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 22, 2014
• First Posted: October 1, 2014
• Study Start: February 1, 2015
• Primary Completion: March 1, 2016
• Study Completion: May 1, 2017
• Last Updated: May 22, 2018

Record last verified: 2018-05

Locations

NL (4)