Effect of Hyperglycaemia and Moxifloxacin on QTc Interval in T2DM (NCT07014735) | Clinical Trial Compass
RecruitingNot Applicable
Effect of Hyperglycaemia and Moxifloxacin on QTc Interval in T2DM
United Kingdom24 participantsStarted 2023-04-13
Plain-language 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.
Who can participate
Age range
18 Years – 64 Years
Sex
ALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. Male or female patients with stable T2DM. Diagnosis of T2DM confirmed by:
. 18-64 years (inclusive) of age (at the date of signing informed consent), with a body mass index of 18 to 35 kg/m², inclusive (at screening).
. Satisfactory medical assessment with no clinically significant or relevant abnormalities as determined by medical history, physical examination, vital signs, 12-lead ECG, and clinical laboratory evaluation (haematology, biochemistry, coagulation, and urinalysis) that is reasonably likely to interfere with the participant's ability to complete the study as assessed by the Investigator.
. Stable patients with insulin resistant type 2 diabetes treated with one of the following:
. Able to wash-out anti-glycaemic therapy for ten half-lives prior to dosing or at D-7, whichever is longer, and for the duration of the trial period up to the end of Day 4.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Clinically significant ECG morphology and interval changes from baseline
Timeframe: Specified timepoints for 4 days and at follow up visit on Day10-D17
2
Cardiac intervals/subintervals calculated using concentration-effect analysis on Days 1, 2, and 3.
Timeframe: Specified timepoints for 3 days
3
The paired PK of blood glucose and moxifloxacin (Cmax)
Timeframe: 4 Days
4
The paired PK of blood glucose and moxifloxacin (Tmax)
Timeframe: 4 days
5
The paired PK of blood glucose and moxifloxacin (AUC)
. Participants must agree to use the following contraceptive requirements for the applicable duration:
. Female participants of non-childbearing potential (WNCBP): Defined as either postmenopausal (evidence of menopause based on a combination of amenorrhea for at least one year and increased serum follicle-stimulating hormone (FSH) level \[\> 30 IU/L\]), or surgical sterilization (evidence of hysterectomy and/or bilateral oophorectomy). CONTRACEPTION REQUIRED: None
. Female participants of childbearing potential (WOCBP) who anticipate being sexually active with a male during the trial (from one complete menstrual cycle prior to the first drug administration until three months after the last drug administration) \*: CONTRACEPTION REQUIRED: Highly effective contraception must start one complete menstrual cycle prior to the first day of dosing and continue until three months after drug administration. Highly effective contraception methods for WOCBP include:
Exclusion criteria
. History or clinical evidence of T2DM related secondary complications in particular autonomic neuropathy, cardiac rhythm disturbances, past medical history of syncope and potassium abnormalities.
. Currently prescribed or used in the last 12 months any form of insulin therapy, or any long half-life diabetic medication that would not wash-out within 7 days.
. History or clinical evidence of any disease and/or existence of any surgical or medical condition which might interfere with the absorption, distribution, metabolism, or excretion of the study drug (appendicectomy and herniotomy allowed).
. History or clinical evidence of significant microvascular disease including chronic kidney failure, macular degeneration or any other disease attributed to the microvascular system that in the Investigator's opinion may affect the outcome of the study.
. Recent hospitalisation due to hypoglycaemia or hyperglycaemia within 28 days before screening.
. History or clinical evidence of any disease with a specific contraindication to moxifloxacin (hypersensitivity, history of tendon disease related to quinolone treatment, and risk of QT prolongation conditions as below).