Phase II Study of Safety and Feasibility of Intensive Blood Glucose Control With Insulin on Acute Medical Wards

NCT00764556 | Completed Phase 2 DMC

• 3 other identifiers: SGH-ClinPharm-1EudraCT 2007-004956-35Ethics 07/H0715/93
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

Patients with chronic obstructive pulmonary disease (COPD) are commonly admitted to hospital with exacerbations of their lung disease. A combination of the acute illness and treatment with oral steroids causes a rise in blood sugar. Patients with high blood sugar do worse than those with normal blood sugar. The aim of this study is to develop a safe and effective protocol for tight control of blood glucose with insulin on acute medical wards outside the intensive care environment. This will allow us to perform a formal trial to determine whether blood glucose control with insulin reduces death and complications from COPD exacerbations.

Conditions

COPD; Hyperglycemia

Keywords

Glucose; Insulin; COPD; Exacerbations; Tight glycaemic control; Acute hospital ward

Outcome Measures

Primary Outcomes (1)

• The frequency of severe hypoglycaemia - Neuroglycopenic symptoms (other than mild agitation) responsive to administration of carbohydrate

  During trial

Secondary Outcomes (7)

• The frequency of symptomatic hypoglycaemia (capillary glucose≤3.3mM AND symptoms consistent with hypoglycaemia)

  During trial

• The frequency of asymptomatic hypoglycaemia (capillary glucose≤3.3mM without any symptoms consistent with hypoglycaemia).

  During treatment

• Mean 24 hour capillary glucose concentrations

  During treatment

• Proportion of capillary glucose measurements in target range (4.4-6.5mM)

  During treatment

• Comparison of capillary blood glucose measurements to those obtained from the Guardian REAL®-time continuous glucose monitoring system

  During monitoring

Study Arms (1)

Tight glycaemic control

EXPERIMENTAL

Intravenous or subcutaneous insulin to control blood glucose to 4.4-6.5mM

Drug: Insulin

Interventions

Insulin DRUG

Intravenous insulin (actrapid) Subcutaneous insulin (aspart, glargine, detemir)

Tight glycaemic control

Eligibility Criteria

• Age: 40 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Physician diagnosis of AECOPD as primary cause for admission
• Able to enter study within 24 hours of admission

You may not qualify if:

• Intensive care unit admission
• Moribund or not for active treatment
• Admission expected to last \<48 hours
• Unable or unwilling to give informed consent
• Known Type I diabetes mellitus
• Patients with reduced awareness of hypoglycaemia including reduced Glasgow coma scale or those taking beta blockers
• Patients with renal or hepatic failure at increased risk of hypoglycaemia

Sponsors & Collaborators

• St George's, University of London: lead

Study Sites (1)

St George's Healthcare NHS Trust

London, SW17 0RE, United Kingdom

Location

Related Publications (2)

• Baker EH, Janaway CH, Philips BJ, Brennan AL, Baines DL, Wood DM, Jones PW. Hyperglycaemia is associated with poor outcomes in patients admitted to hospital with acute exacerbations of chronic obstructive pulmonary disease. Thorax. 2006 Apr;61(4):284-9. doi: 10.1136/thx.2005.051029. Epub 2006 Jan 31.

  PMID: 16449265 BACKGROUND

• Archer JR, Misra S, Simmgen M, Jones PW, Baker EH. Phase II study of tight glycaemic control in COPD patients with exacerbations admitted to the acute medical unit. BMJ Open. 2011 Jul 23;1(1):e000210. doi: 10.1136/bmjopen-2011-000210.

  PMID: 22021788 DERIVED

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive; Hyperglycemia; Insulin Resistance

Interventions

Insulin

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)

Proinsulin; Insulins; Pancreatic Hormones; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Peptides; Amino Acids, Peptides, and Proteins

Study Officials

• Emma H Baker, PhD, FRCP

  St George's, University of London

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: October 1, 2008
• First Posted: October 2, 2008
• Study Start: May 1, 2008
• Primary Completion: May 1, 2009
• Study Completion: May 1, 2009
• Last Updated: October 14, 2009

Record last verified: 2009-10

Locations

GB (1)