RecruitingNot ApplicableNCT07014735

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)


Sponsor

Richmond Pharmacology Limited

Enrollment

24 participants

Start Date

Apr 13, 2023

Study Type

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

Min Age: 18 YearsMax Age: 64 Years

Plain Language Summary

Simplified for easier understanding

This study is examining how high blood sugar levels and the antibiotic moxifloxacin affect the heart's electrical rhythm (specifically the QTc interval) in people with type 2 diabetes. Understanding this interaction could improve medication safety for people with diabetes. **You may be eligible if...** - You are between 18 and 64 years old with stable type 2 diabetes - Your HbA1c (long-term blood sugar measure) is between 6.5% and 9.5% - You show signs of insulin resistance - You manage your diabetes with diet/exercise alone or a single diabetes medication (metformin, DPP-4 inhibitor, pioglitazone, a sulfonylurea, or an SGLT-2 inhibitor) - Your BMI is between 18 and 35 kg/m² **You may NOT be eligible if...** - You are on insulin therapy - You take multiple diabetes medications - You have significant heart, kidney, or liver problems - You are pregnant or planning to become pregnant - You are unable to temporarily stop your diabetes medication during the study Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGglucose

Participants will receive treatments with glucose or matching placebo (please see study design section).

DRUGmoxifloxacin

Participants will receive moxifloxacin or matching placebo (please see study design section).


Locations(1)

Richmond Pharmacology Ltd.

London, United Kingdom

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NCT07014735


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