The GAPSID Study - How GLP-1 Analogues Prevent Steroid-Induced Diabetes

NCT06318442 · Recruiting

Last updated 2026-05-28

This clinical trial is testing whether GLP-1 analogues can help prevent diabetes in people who develop high blood sugar due to steroid medications.

Status Recruiting Currently enrolling participants.

Phase Not applicable Not a phased drug trial (e.g. a device or behavioral study).

Type Interventional (clinical trial)

Design Randomized, quadruple-blind basic-science study

Participants 60 people Planned (estimated).

Who can join Ages 18+ · all sexes Healthy volunteers accepted.

Timeline Started 2024-05 · est. completion 2027-06

Where 1 site · United Kingdom

What this study is testing ClinicalTrials.gov NCT06318442 ↗

Description as written by the study sponsor.

TITLE: How GLP-1 Analogues prevent steroid-induced diabetes (The GAPSID Study) DESIGN: A double-blind study evaluating how GLP-1 analogues, compared with metformin, prevent hyperglycaemia in response to a 7-day course of dexamethasone (DEX) 6 mg once daily. This is a mechanistic experimental medicine study. AIMS: To evaluate the mechanisms by which GLP-1 analogues reduce steroid-induced hyperglycaemia compared to metformin. OUTCOME MEASURES: * Primary: Glucose tolerance in response to standardised mixed meal test (MMT) lasting for 240 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 approximately 8 individuals in each group. ELIGIBILITY: People living with pre-diabetes or lifestyle controlled diabetes STUDY DURATION: This study will take place over 3 weeks for each partcipant. Study procedures include 10 days of baseline continuous glucose monitoring (CGM) followed by 7 days of dexamethasone with GLP-1, metformin or placebo. Participants will attend a follow-up visit 3-5 days after completing the 7-day course of study drug. The study will run over a period of 3 years. ANTICIPATED IMPACT: Mechanistic evidence for the use of GLP-1 analogues, compared with metformin, in the treatment of steroid-induced diabetes.

Treatments tested

Semaglutide Oral Product Drug

Oral semaglutide 3mg once uptitrated to twice daily
Metformin Oral Tablet Drug

Metformin modified release tablets 500mg once daily uptitrated to twice daily).
Placebo Drug

Placebo tablets

Main thing measured	Difference in Glucose tolerance
Sponsor	Imperial College London
Conditions studied	Steroid-Induced Diabetes, Steroid Induced Hyperglycemia
GLP-1 drugs	—

Full protocol, eligibility, and contacts on ClinicalTrials.gov NCT06318442 ↗