At a glance
- What the study gets you
- Access to the study treatment being tested
- Type of study
- Interventional (receives a drug or procedure)
- Time in hospital
- In-person visits at study sites — visit count not specified by the sponsor
- Drug or intervention
- Semaglutide Oral Product (drug), Metformin Oral Tablet (drug), Placebo (drug)
- How long the study runs
- Study runs about 37 months (dates as stated)
- About the drug or intervention
- 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
- Patient visit burden
- Not specified by the sponsor
- Type of study
- Testing a treatment
- Ages
- 18 Years and over
- Who
- All
- Number of participants
- 60
- Started
- 2024-05-15
- Last checked
- 2024-09
Plain English Summary
What is this study?
- • Testing a new treatment for steroid-induced diabetes
- • NA - 60 participants
- • 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
Who can take part?
- • Ages 18 Years and over
- • Diagnosed with steroid-induced diabetes
Where?
- • London - Imperial College Healthcare NHS Trust
This is a simplified summary. Always discuss with your doctor before making any decisions.
About This Trial
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.
How this trial compares with your answers
Answer 2 more questions to improve match
What we know so far
Still need:
- • Tell us your age for better matching
- • Tell us your sex for better matching
Preliminary match based on your answers. Full eligibility requires on-site assessment including medical history, physical exam, and lab tests. This does not guarantee enrolment.
Eligibility at a Glance
Key info
- Age: 18 Years and over
- Who can join: All genders
Biomarkers mentioned
What the study is looking for
- ✓Adults ≥ 18 years;
- ✓Male or female;
- ✓Pre-diabetes (HbA1c ≥42 and \<47 mmol/mol, or lifestyle-controlled diabetes (HbA1c ≥48 and ≤52 mmol/mol);...
- ✓Body mass index ≥22.5 kg/m2
Who cannot take part
- ✗Prior treatment with any diabetes medication within 90 days;
- ✗Current or planned pregnancy, or current breastfeeding;
- ✗Previous treatment with GC (topical, oral, injected) within 30 days or 90 days for extended-release injected GCs...
- ✗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).
See the full criteria
Where Is This Study? (1 UK site)
Imperial College Healthcare NHS Trust
London, United Kingdom
How to Get in Touch
Katharine Lazarus, MBChB, BSc
Sponsor contactCONTACT