Effect of Hyperglycaemia and Moxifloxacin on QTc Interval in T2DM
A Single Centre, Placebo-controlled Study to Evaluate the Combined Effect of Hyperglycaemia and a QTc-prolonging Medication on Cardiac Repolarisation in Male and Female Patients With Insulin Resistant Type 2 Diabetes Mellitus (T2DM)
Richmond Pharmacology Limited
24 participants
Apr 13, 2023
INTERVENTIONAL
Conditions
Summary
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.
Eligibility
Plain Language Summary
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Interventions
Participants will receive treatments with glucose or matching placebo (please see study design section).
Participants will receive moxifloxacin or matching placebo (please see study design section).
Locations(1)
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NCT07014735