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Trial registered on ANZCTR

Registration number
Ethics application status
Date submitted
Date registered
Date last updated
Type of registration
Retrospectively registered

Titles & IDs
Public title
Does exogenous glucagon-like peptide-1 (GLP-1) attenuates the glycaemic response to small intestinal nutrient in critically ill patients with pre-existing type-2 diabetes?
Scientific title
The effect of exogenous glucagon-like peptide-1 (GLP-1) compared to placebo on glycaemia in critically ill patients with pre-existing type-2 diabetes during small intestinal feeding
Secondary ID [1] 283868 0
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Blood Glucose 243520 0
Type-2 Diabetes 256893 0
Condition category
Condition code
Metabolic and Endocrine 239818 239818 0 0

Study type
Description of intervention(s) / exposure
Intravenous Glucagon-like peptide-1 (reconstituted in 4%albumin) at 1.2pmol/kg/min will be administered for 270 min at 1ml/min. The infusion will commence 30 minutes prior to the commencement of intestinal nutrient infusion. Seperated by 24 hours the cross-over treatment is placebo (intravenous 4% Albumin at 1ml/min for 270 min), again commenced 30 minutes prior to intestinal nutrient infusion
Intervention code [1] 241132 0
Treatment: Drugs
Comparator / control treatment
Cross-over study Cross-over treatment is 4% albumin infusion (which has no effect on blood glucose) infused at 1ml/min between t=0-270minutes
Control group

Primary outcome [1] 240582 0
Blood glucose during small intestinal feeding (as measured as Area under the curve)
Timepoint [1] 240582 0
4 hours (30-270 min)
Secondary outcome [1] 257210 0
Blood glucose (time above 10 mmol/l)
Timepoint [1] 257210 0
actual time. Blood glucose will be monitored every 15 minutes throughout the study period
Secondary outcome [2] 257211 0
Peak blood glucose
Timepoint [2] 257211 0
actual time between t=30-270 min
Secondary outcome [3] 257212 0
Regulatory and counter-regulatory hormone release. Measured using plasma Insulin and glucagon concentrations
Timepoint [3] 257212 0
Every 30 minutes for the first 150 minutes and thereafter every 60 minutes until 270 min

Key inclusion criteria
Inclusion criteria
Critically ill patients with pre-existing type- 2 diabetes (not requiring insulin prior to hospital) and who require artificial ventilation
Likely to be ventilated for >48hrs
Suitable to receive enteral nutrition via naso-jejunal feeding tube
Minimum age
18 Years
Maximum age
85 Years
Both males and females
Can healthy volunteers participate?
Key exclusion criteria
Age <18 Age>85 Pregnancy Small bowel obstruction History of insulin-requiring diabetes Previous surgery on the oesophagus, stomoach or duodenum Any gastrointestinal surgery on this admission

Study design
Purpose of the study
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Patients admitted to the Intensive Care Unit (ICU) of the Royal Adelaide Hospital will be screened. Next of kin will be approached for informed consent. Synthetic GLP-1-(7-36) amide is reconstituted by the Royal Adelaide Hospital department of pharmacy, as a solution in 4% albumin. Randomisation is performed by the department of pharmacy, so that on each study day the investigators receive the study drug in a glass bottle covered by black plastic
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
computer sequence generation
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?

Intervention assignment
Other design features
Phase 2
Type of endpoint(s)
Statistical methods / analysis

Recruitment status
Date of first participant enrolment
Date of last participant enrolment
Date of last data collection
Sample size
Accrual to date
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 237504 0
Self funded/Unfunded
Name [1] 237504 0
Address [1] 237504 0
Country [1] 237504 0
Primary sponsor type
Adam Deane
Intensive Care Unit, Level 4, Royal Adelaide Hospital North Terrace Adelaide SA 5000
Secondary sponsor category [1] 236984 0
Name [1] 236984 0
Address [1] 236984 0
Country [1] 236984 0

Ethics approval
Ethics application status
Ethics committee name [1] 243631 0
Royal Adelaide Hospital Research Ethics Committee
Ethics committee address [1] 243631 0
Level 3 Hanson Insititute North Terrace Adelaide SA 5000
Ethics committee country [1] 243631 0
Date submitted for ethics approval [1] 243631 0
Approval date [1] 243631 0
Ethics approval number [1] 243631 0

Brief summary
The primary objective of this study is to establish if glucagon-like peptide-1 (a hormone released from the gastrointestinal) has an effect on blood sugar levels in diabetic patients who are critically ill
Trial website
Trial related presentations / publications
The results from this study were published in an international medical journal:

Crit Care. 2011;15(1):R35.

Exogenous glucagon-like peptide-1 attenuates the glycaemic response to postpyloric nutrient infusion in critically ill patients with type-2 diabetes.
Deane AM, Summers MJ, Zaknic AV, Chapman MJ, Fraser RJ, Di Bartolomeo AE, Wishart JM, Horowitz M.
Public notes

Principal investigator
Name 30053 0
Dr Adam Deane
Address 30053 0
Royal Adelaide Hospital
North Terrace
Adelaide, SA
Country 30053 0
Phone 30053 0
+61 8 8222 4000
Fax 30053 0
Email 30053 0
Contact person for public queries
Name 13300 0
Dr Adam Deane
Address 13300 0
Intensive Care Unit
Level 4
Royal Adelaide Hospital
North Terrace
SA 5000
Country 13300 0
Phone 13300 0
+61 8 8222 4000
Fax 13300 0
Email 13300 0
Contact person for scientific queries
Name 4228 0
Dr Adam Deane
Address 4228 0
Intensive Care Unit
Level 4
Royal Adelaide Hospital
North Terrace
SA 5000
Country 4228 0
Phone 4228 0
+61 8 8222 4000
Fax 4228 0
Email 4228 0

No information has been provided regarding IPD availability
Summary results
Have study results been published in a peer-reviewed journal?
Other publications
Have study results been made publicly available in another format?
Results – basic reporting
Results – plain English summary