The GAPSID Study (CPMS: 58414, IRAS: 331830)

UPDATED - 10/08/2026

TITLE: GLP-1 Analogues for the treatment of steroid-induced diabetes (GATSID Study)

DESIGN: A double-blind mechanistic randomised trial evaluating the effect of the GLP-1 analogue,liraglutide,compared with metformin,on glycaemia in response to a 7-day course of dexamethasone 6 mg once daily. 60 participants will be randomised in a 1:1:1 ratio to one of three treatment arms: Placebo liraglutide and placebo metformin,liraglutide and placebo metformin,placebo liraglutide and metformin.

AIMS: To investigate the use of GLP-1 analogues vs. metformin for the treatment of steroid-induced diabetes.

OUTCOME MEASURES:

• Primary: Glucose tolerance in response to standardised mixed meal test (MMT) lasting for 180 minutes,measured in all participants at baseline and on day 7 DEX.

• Secondary: Indices of insulin resistance (M-value),beta-cell function (acute insulin response to glucose) and disposition,as measured by a combined IV glucose tolerance test and hyperinsulinaemic-euglycaemic clamp,performed at baseline and on day 7 DEX.

• Exploratory: Tissue specific changes in adipose AMPK determined from adipose and muscle biopsies,taken from a subset of 8 individuals in each group.

ELIGIBILITY: People living with pre-diabetes or lifestyle controlled diabetes

STUDY DURATION: 7 days of study treatment and intervention. There will be 10 days preceding the start of the intervention with baseline CGM monitoring and a follow-up visit 3 days after completion of the study intervention.

ANTICIPATED IMPACT: Translatable evidence for the use of GLP-1 analogues in the treatment of steroid-induced diabetes.

INCLUSION CRITERIA:

• Adults ≥ 18 years

• Male or female

• Pre-diabetes (HbA1c ≥42 and <47 mmol/mol,or lifestyle-controlled diabetes (HbA1c ≥48 and ≤52 mmol/mol); measurements within range on two separate occasions ≥90 days apart)

• Body mass index ≥22.5 kg/m2

INCLUSION CRITERIA:

• Prior treatment with any diabetes medication within 90 days

• Current or planned pregnancy

• Previous treatment with GC (topical,oral,injected) within 30 days or 90 days for extended-release injected GCs (e.g. Depo-Medrone)

• Continuing requirement for GC treatment (e.g. for steroid replacement,chronic inflammatory or immunological condition)

• Treatment with medications altering DEX pharmacokinetics (e.g. phenytoin,carbamazepine,ritonavir)

• History of pancreatitis,renal disease (eGFR <30),severe hepatic impairment,gallbladder disorders,or GI disease (e.g. IBD),heart failure,history of medullary thyroid cancer (MTC),or previous skin reactions.

• History of bleeding disorders of anticoagulant therapies (exclusion from the biopsy sub-study only)

• History of any other medical, psychological condition or use of any medications, which, in the opinion of the investigators would either interfere with the study or compromise the safety of the participant.

STUDY RESOURCES

Access for the SystmOne and EMIS study resources can be requested below.

For further guidance on using the resources, please refer to the guidance documents and further useful information on the PRIDES page.

The searches have been created with the study specific inclusion and exclusion criteria. 

If you require any further information or help, please contact the IT Specialists:

EMIS: Jodie Button – jodie.button@nihr.ac.uk 

SystmOne:  Sharon Harper - sharon.harper2@nhs.net

Disclaimer:

Please note the resources provided are designed to assist with the identification of potentially suitable patients and to appropriately code these patients if required.

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