Actively Recruiting
A Placebo-Controlled Study Evaluating Hyperglycaemia and Moxifloxacin Effects on Heart Electrical Activity in Insulin Resistant Type 2 Diabetes
Led by Richmond Pharmacology Limited · Updated on 2025-06-11
24
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
Sponsors
R
Richmond Pharmacology Limited
Lead Sponsor
R
Richmond Research Institute
Collaborating Sponsor
AI-Summary
What this Trial Is About
Diabetes, especially type 2 diabetes (T2DM) with insulin resistance, is linked to an increased risk of sudden cardiac death. This risk is partly related to changes in the heart's electrical activity, measured by QTc interval prolongation on ECGs. Researchers are studying how the antibiotic moxifloxacin might worsen QTc prolongation in people with T2DM, particularly when blood sugar levels are high or insulin is deficient. The study also aims to explore differences between males and females and analyze blood markers to understand the molecular reasons behind these effects. Participants in this study will receive controlled doses of glucose and moxifloxacin or placebos in a randomized, single-blind setting. On Day 1, participants get glucose with a placebo for moxifloxacin, while on Day 3 they receive intravenous glucose combined with moxifloxacin infused over 45 minutes. Blood glucose levels will be carefully raised and maintained at high levels for a set time, monitored continuously with glucose sensors and blood samples. The study includes both inpatient stays for treatment and outpatient follow-up visits. During the study, participants will undergo regular ECGs to measure heart electrical activity, blood tests to track glucose and moxifloxacin levels, and monitoring for any side effects. Outcomes measured include changes in ECG intervals and heart rhythms, pharmacokinetic profiles of glucose and moxifloxacin, and differences between sexes. The trial lasts several days with follow-up visits up to about 75 days after initial treatment to ensure participant safety and collect final data.
CONDITIONS
Brief Title
Effect of Hyperglycaemia and Moxifloxacin on QTc Interval in T2DM
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Male or female patients aged 18 to 64 years with stable type 2 diabetes mellitus (T2DM)
- HbA1c between 48 and 80 mmol/mol (6.5% to 9.5%), with possible inclusion up to 90 mmol/mol with endocrinologist approval
- Evidence of high insulin resistance (HOMA2-IR score >0.55)
- Body mass index (BMI) between 18 and 35 kg/m²
- Stable treatment with diet/exercise alone or specific anti-glycaemic monotherapy
- Able to wash out anti-glycaemic therapy for required duration before dosing
- Agree to use required contraception methods if applicable
- Able to provide informed consent and comply with study procedures
You will not qualify if you...
- History or evidence of T2DM complications like autonomic neuropathy or cardiac rhythm issues
- Insulin therapy or long half-life diabetic medication use within last 12 months
- Medical conditions affecting drug absorption or metabolism (except appendicectomy/herniotomy)
- Significant microvascular disease or recent hospitalisation for blood sugar issues
- Contraindications to moxifloxacin or history of related heart conditions
- Clinically significant arrhythmias, ischemic heart disease, or ECG abnormalities interfering with QTc analysis
- Vital signs outside specified normal ranges
- Acute illness within 4 weeks before screening
- Unsuitable veins for intravenous access
- Hypersensitivity to study medications
- Recent use of disallowed medications or antibiotics
- Positive tests for hepatitis B, C, or HIV
- Pregnancy or breastfeeding
- Substance abuse or tobacco use within specified timeframes
- Legal, mental, or language barriers affecting study compliance
- Inability to follow diet/fasting requirements
- Prior screen failure or participation in this study
- Blood/plasma donation during study and 3 months after
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 4 days
Participants stay in the clinical trials unit to receive treatments with glucose and moxifloxacin or placebos while being closely monitored for side effects.
Daily inpatient visits over 4 days
Duration - 6 to 13 days after treatment
Participants return to the unit for an outpatient appointment to assess safety and cardiac effects after treatment.
1 follow-up visit (in-person)
Trial Site Locations
Total: 1 location
1
Richmond Pharmacology Ltd.
London, United Kingdom, SE1 1YR
Actively Recruiting
Research Team
E
Emma Akuffo
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
BASIC_SCIENCE
Number of Arms
2
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