Actively Recruiting
Effect of Hyperglycaemia and Moxifloxacin on QTc Interval in T2DM
Led by Richmond Pharmacology Limited · Updated on 2025-06-11
24
Participants Needed
1
Research Sites
141 weeks
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 is a significant risk factor for sudden cardiac death, with the QTc interval on electrocardiograms (ECGs) often prolonged in diabetic patients due to factors such as hyperglycaemia and insulin resistance. Drugs like moxifloxacin can further exacerbate this effect, especially in those with diabetes. A previous trial on Type 1 diabetes suggested that hyperglycaemia and moxifloxacin have additive effects, prompting an investigation into whether similar effects occur in Type 2 diabetes (T2DM), particularly in individuals with high insulin resistance. This study aims to evaluate whether moxifloxacin-induced QT-prolongation is amplified by elevated blood glucose levels or insulin deficiency in T2DM patients, considering potential differences between sexes. Blood biomarkers will be analysed to understand the underlying molecular mechanisms. The trial will involve at least 24 male and female participants with insulin-resistant T2DM, aged 18 to 64 years, conducted at Richmond Pharmacology Ltd. Participants will receive treatments with glucose, moxifloxacin, and placebos while closely monitored for side effects during an inpatient stay, followed by outpatient appointments.
CONDITIONS
Official 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 with stable Type 2 diabetes mellitus (T2DM) confirmed by medical records and HbA1c between 48 and 80 mmol/mol (6.5% to 9.5%), with possible extension up to 90 mmol/mol upon endocrinologist approval.
- Evidence of high insulin resistance defined by a HOMA2-IR score above 0.55.
- Age between 18 and 64 years inclusive, with a body mass index of 18 to 35 kg/m².
- Stable T2DM patients treated with diet and exercise alone or specific anti-glycaemic monotherapies such as metformin, DPP-4 inhibitors, pioglitazone, sulfonylureas, or SGLT-2 inhibitors.
- Ability to wash out anti-glycaemic therapy for ten half-lives or at least seven days prior to dosing and throughout the trial up to Day 4.
- Agreement to use specified contraceptive measures or abstinence during the trial period according to gender and reproductive status.
- Ability to provide written informed consent and comply fully with study procedures and restrictions.
You will not qualify if you...
- History or evidence of T2DM-related complications like autonomic neuropathy, cardiac rhythm disturbances, syncope, or potassium abnormalities.
- Use of insulin therapy or long half-life diabetic medication within the last 12 months.
- Any disease or condition that might affect drug absorption, metabolism, or excretion except minor surgeries like appendicectomy and herniotomy.
- Significant microvascular disease including chronic kidney failure or macular degeneration.
- Hospitalization for hypoglycaemia or hyperglycaemia within 28 days before screening.
- Contraindications to moxifloxacin including hypersensitivity, tendon disease related to quinolones, or risk factors for QT prolongation.
- History of syncope, sudden cardiac death in family, congenital long QT syndrome, or specific cardiac arrhythmias.
- History of ischemic heart disease or angina.
- Conditions leading to electrolyte imbalances unrelated to T2DM.
- ECG abnormalities that interfere with QTc interval analysis.
- Vital signs outside specified normal ranges.
- Acute illness within four weeks prior to screening.
- Unsuitable veins for intravenous access.
- Known hypersensitivity to trial medications including quinolones.
- Recent use of prohibited medications or antibiotics.
- Participation in other investigational drug studies recently.
- Positive tests for alcohol, drugs, or certain infections.
- Pregnancy or breastfeeding.
- History of drug or alcohol abuse within five years.
- Tobacco or nicotine use within one month prior to dosing.
- Legal or mental incapacity or language barriers preventing study compliance.
- Inability to follow diet or fasting requirements.
- Prior screen failure or participation in this study.
- Inability to abstain from blood or plasma donation during and for three months after the study.
AI-Screening
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Trial Site Locations
Total: 1 location
1
Richmond Pharmacology Ltd.
London, United Kingdom, SE1 1YR
Actively Recruiting
Research Team
E
Emma Akuffo
CONTACT
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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