Effect of hyperglycaemia and moxifloxacin on QTc interval in T2DM
Research type
Research Study
Full title
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)
IRAS ID
320068
Contact name
Jorg Taubel
Contact email
Sponsor organisation
Richmond Pharmacology Ltd
Duration of Study in the UK
0 years, 3 months, 19 days
Research summary
Diabetes has been established as a key independent risk factor for sudden cardiac death, a common cause of death from cardiovascular disease. The underlying mechanisms for this seem to be complex and multifactorial, but a change in the electrocardiogram (ECG)(which measures the electrical activity of the heart) parameter called QTc interval has been identified as potentially having a significant role. In patients with diabetes, QT interval prolongation is frequently reported. High blood glucose levels (hyperglycaemia) and insulin resistance (the condition where the body does not respond well to insulin) are thought to be important causes. We also know that some drugs e.g., moxifloxacin (a common antibiotic) can prolong the QT interval and this effect can be more pronounced in patients with diabetes.
We have previously conducted a trial on Type 1 diabetes showing that the effects of hyperglycaemia and moxifloxacin were additive. This led to our hypothesis that similar effects might be observed in type 2 diabetes (T2DM), specifically in those with high insulin resistance. Understanding whether the well-established QT-prolongation caused by moxifloxacin is exaggerated by elevated levels of blood glucose alone or by an insulin deficiency is important for evaluating the risk to patients with T2DM and the potential prevention of cardiac complications. We would also like to determine if the effect varies between sexes and gain a comprehensive understanding of the molecular factors driving these differences by analysing blood biomarkers.
This trial will be conducted at Richmond Pharmacology Ltd. involving a minimum of 24 male and female participants with insulin-resistant T2DM, aged 18 to 64 years. They will stay in the clinical trials unit, receive treatments with glucose, moxifloxacin, and placebos and will be monitored closely for any side effects. Following the inpatient stay, participants will return to the unit for an outpatient appointment.
REC name
London - London Bridge Research Ethics Committee
REC reference
23/LO/0138
Date of REC Opinion
30 Mar 2023
REC opinion
Further Information Favourable Opinion