Insulin Therapy in Chronic Obstructive Pulmonary Disease (COPD) Exacerbations

NCT00467636 | Terminated DMC

• 1 other identifier: COPD1
• Study Type: interventional
• Target: 51
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to determine the effect of preventing hyperglycaemia in patients admitted to hospital with acute exacerbations of chronic pulmonary disease.

Conditions

Chronic Obstructive Pulmonary Disease; Hyperglycemia

Keywords

Chronic Obstructive Pulmonary Disease; Corticosteroid induced hyperglycaemia; Insulin

Outcome Measures

Primary Outcomes (1)

• Rate of re-admission to hospital within 90 days.

  90 days after discharged from hospital

Secondary Outcomes (7)

• Length of stay

  oct 2009

• In-patient mortality

  look at cause death. for statistical purpose oct 2009

• Spirometry at baseline, day 3 and prior to discharge

  oct 2009

• Achieved glucose levels

  oct 2009

• Hypoglycaemic events (<4 mmol/l with or without symptoms)

  instigate hypoglycaemia protocol at time. for statistical purpose oct 2009.

Study Arms (2)

Insulin Glulisine

EXPERIMENTAL

Blood glucose monitoring and treatment of hyperglycaemia with insulin. Insulin to be with-held if pre meal blood glucose \< 4 mmol/l.

Drug: Insulin Glulisine

2

ACTIVE COMPARATOR

Blood glucose monitoring for comparison with treatment arm (1)

Procedure: Blood glucose monitoring

Interventions

Blood glucose monitoring PROCEDURE

Regular pre and post meal blood glucose monitoring.

2

Insulin Glulisine DRUG

Sub cutaneous injection given twice daily for 3 days. Dosage titrated to body mass index and body weight (BMI \< 30 = 0.1 unit/kg. BMI \> 30 = 0.2 unit/kg)

Also known as: Apidra

Insulin Glulisine

Eligibility Criteria

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

You may qualify if:

• Patients who are NOT diabetic, admitted with COPD who are likely to be prescribed corticosteroids as part of usual care with an admission glucose level (before steroids) between 6.1 and 11.1 mmol/l.

You may not qualify if:

• Patients with diabetes mellitus
• Patients who are nil by mouth.
• Patients with severe co-morbid disease with an anticipated life expectancy of \< 6 months.
• Patients who are unable to provide informed consent.
• Age \<18 years.

Sponsors & Collaborators

• The Royal Bournemouth Hospital: lead
• Sanofi: collaborator

Study Sites (1)

Royal Bournemouth Hospital

Bournemouth, Dorset, BH7 7DW, United Kingdom

Location

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive; Hyperglycemia; Insulin Resistance

Interventions

Blood Glucose; insulin glulisine

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; Hyperinsulinism

Intervention Hierarchy (Ancestors)

Glucose; Hexoses; Monosaccharides; Sugars; Carbohydrates

Study Officials

• David Kerr, MD

  Royal Bournemouth Hospital NHS Trust

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: April 27, 2007
• First Posted: April 30, 2007
• Study Start: July 1, 2007
• Primary Completion: May 1, 2009
• Study Completion: May 1, 2009
• Last Updated: October 2, 2009

Record last verified: 2009-10

Locations

GB (1)