Novel approaches to manage glucocorticoid-induced diabetes in hospital inpatients

• Register: ANZCTR
• Last refreshed on: 13 January 2020
• Main ID: ACTRN12615000333516
• Date of registration: 13/04/2015
• Prospective Registration: No
• Primary sponsor: Alfred Hospital
• Public title: Novel approaches to manage glucocorticoid-induced diabetes in hospital inpatients
• Scientific title: The effects of liraglutide vs insulin on glycaemic control in inpatients with glucocorticoid-induced diabetes
• Date of first enrolment: 29/05/2014
• Target sample size: 30
• Recruitment status: Stopped early
• URL: https://anzctr.org.au/ACTRN12615000333516.aspx
• Study type: Interventional
• Study design: Purpose: Treatment; Allocation: Randomised controlled trial; Masking: Open (masking not used);Assignment: Parallel;Type of endpoint: Safety/efficacy;
• Phase: Phase 4

Countries of recruitment

Australia

Contacts

• Name: Prof Leon Bach

• Name: Prof Leon Bach

Key inclusion & exclusion criteria

Inclusion criteria: Glucocorticoid-induced or exacerbated diabetes treated with insulin and/or oral glucose-lowering medication(s)
Glucose >= 15 mmol/l
Exclusion criteria: Type 1 diabetes
Admission to intensive care
Likely to require surgical intervention
Likely to be admitted <48 h
eGFR <15 ml/min
Acute vomiting or history of gastroparesis
Known allergy to insulin or GLP-1 agonists
Proliferative retinopathy
Premenopausal females

Age minimum: 18 Years
Age maximum: 85 Years
Gender: Both males and females

Health Condition(s) or Problem(s) studied

glucocorticoid-induced or -exacerbated diabetes;
glucocorticoid-induced or -exacerbated diabetes

Metabolic and Endocrine - Diabetes

Intervention(s)

Basal insulin (0.2 U/kg by subcutaneous injection in the morning) + liraglutide (0.6 mg by subcutaneous injection in the morning) for 72 h

Primary Outcome(s)

Time spent with normoglycaemia as determined by continuous glucose monitoring[72 h]

Secondary Outcome(s)

glycemic variability as determined by continuous glucose monitoring[72 h]

mean glucose as determined by continuous glucose monitoring[72 h]

Hypoglycaemia (BGL < 3.5 mmol/L and/or clinical evidence of hypoglycaemia) as determined by continuous glucose monitoring[72 h]

Hyperglycaemia (BGL>18 mmol/L) as determined by continuous glucose monitoring[72 h]

peak glucose as determined by continuous glucose monitoring[72 h]

total daily insulin obtained from drug chart[72 h]

Secondary ID(s)

Nil known

Source(s) of Monetary Support

Novo-Nordisk Regional Grant Scheme

Ethics review

Status: Approved
Approval date:
Contact:

Alfred Health Human Ethics Committee