DiabetesPhase 1NCT01984827
Effect of Glucose on QTc Interval in Type 1 Diabetes
A Phase 1 study testing Moxifloxacin and hyper-glycaemic clamp in people with Diabetes, run by Richmond Research Institute at 1 site in United Kingdom.
Trial summary
High blood glucose levels (hyperglycaemia) and Moxifloxacin (a commonly used antibiotic) have both been shown independently to affect heart activity in healthy volunteers as recorded by ECG. i.e. Read more about this study
- Who is it for?
- Ages 20 to 64 years
- Conditions the study is for
- Diabetes
- What is being tested?
- Moxifloxacin and hyper-glycaemic clamp
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 24 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 10 Feb 2019to 31 Dec 2020
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 64 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- A subject will be eligible for inclusion in this study only if all of the following criteria apply:
- Subject is a male or female with a confirmed diagnosis of C-peptide deficiency Type 1 diabetes mellitus, HbA1c levels of ≤ 60 mmol/mol and 20 - 64 years of age (inclusive) at screening.
- Healthy (apart from the confirmed diagnosis of C-peptide deficiency Type 1 diabetes mellitus) on the physical examination at screening and at admission on Day -1.
- Body mass index (BMI) between 18 and 30 kg/m2 (inclusive) at screening and at admission on Day -1, body weight at least 48 kg.
- Haematology, biochemistry and urinalysis test results within the normal range to a clinically relevant extent at screening and at admission.
- Female subjects who are either:
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- Non-childbearing potential, e.g. post-menopausal (as defined as amenorrhoea for at least 12 months with no alternative medical cause) or permanently sterile (permanent sterilisation methods include hysterectomy, bilateral salpingectomy and bilateral oophorectomy) OR
- Childbearing potential AND (if heterosexually active) agree to use one or more forms of highly effective contraception as defined below, starting at least one menstrual cycle before first study drug administration and continuing until at least 3 months after the end of the systemic exposure of the study drug.
- Highly effective contraceptive methods for females are as follows:
- Combined (oestrogen- and progestogen-containing) hormonal contraception associated with inhibition of ovulation as follows:
- Oral
- Intravaginal
- Transdermal
- Progestogen-only hormonal contraception associated with inhibition of ovulation as follows:
- Oral
- Injectable
- Implantable
- Intrauterine device (IUD)
- Intrauterine hormone-releasing system (IUS)
- Bilateral tubal occlusion
- Male partner vasectomised (with documented evidence of azoospermia)
- Male subjects, if heterosexually active and with a female partner of childbearing potential or a pregnant or breastfeeding partner, must agree to use barrier contraception (male condom) for the treatment period and for at least 3 months after study drug administration. Female partners of male subjects who are of childbearing potential must use one or more forms of highly effective contraception as defined above, starting at least one menstrual cycle before (the male subject's) first study drug administration and continuing until at least 3 months after the last dose of the study drug.
- For male subjects who have had a vasectomy (with documented evidence of azoospermia if possible) and agree to use a barrier method (male condom) for the stated time period, no additional contraceptive method is required by their female partner.
- Ability to provide written, personally signed, and dated informed consent to participate in the study, in accordance with the ICH Good Clinical Practice (GCP) Guideline E6 (1996) and applicable regulations, before completing any study-related procedures.
- Ability to communicate well with the Investigator in the local language, and to understand and comply with the requirements of the study.
- Subject has a stable diabetic treatment regimen.
Who cannot join
- A subject will not be eligible for inclusion in this study if any of the following criteria apply:
- History or clinical evidence of Type 1 diabetes mellitus related secondary complications in particular autonomic neuropathy, rhythm disturbances, post medical history of syncope and potassium abnormalities.
- 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 (appendectomy and herniotomy allowed, cholecystectomy not allowed).
- History or clinical evidence of 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 the past one month.
- History of clinically significant syncope.
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- Family history of sudden death.
- Clinically significant history or family history of congenital long QT syndrome (e.g. Romano-Ward syndrome, Jervell and Lange-Nielson syndrome) or Brugada's syndrome.
- History of clinically significant arrhythmias and ischemic heart disease (especially ventricular arrhythmias, atrial fibrillation (AF), recent conversion from AF or coronary spasm).
- Conditions predisposing the volunteer to electrolyte imbalances other than Type 1 diabetes (e.g. altered nutritional states, chronic vomiting, anorexia nervosa, bulimia nervosa).
- ECG abnormalities in the standard 12-lead ECG (at screening, Day -1 or pre-dose of Day 1) and 24-hour 12 lead Holter ECG or an equivalent assessment and/or submaximal exercise test (at screening) which in the opinion of the Investigator will interfere with the ECG analysis.
- Any clinically important abnormalities in rhythm, conduction or morphology of resting ECG that may interfere with the interpretation of QTc interval changes. This includes subjects with any of the following (at screening, Day-1 or pre-dose of Day 1):
- Sinus node dysfunction.
- Clinically significant PR (PQ) interval prolongation.
- Intermittent second or third degree AV block.
- Incomplete or complete bundle branch block.
- Sustained cardiac arrhythmia's including (but not limited to) atrial fibrillation or supraventricular tachycardia; any symptomatic arrhythmia with the exception of isolated extra systoles.
- More than 200 ventricular ectopic beats in 24 hours.
- Ventricular tachycardia (ventricular tachycardia defined as ≥ 3 successive ventricular ectopic beats at a rate of > 120 bpm).
- Abnormal T wave morphology.
- QT interval corrected using the Fridericia's formula (QTcF) > 450 ms. Subject with borderline deviations from these criteria may be included if the deviations do not pose a safety risk, and if agreed between the appointed Cardiologist and the PI.
- Has vital signs outside of the following normal range at screening, Day -1 or Day 1 predose:
- Blood pressure (BP):
- Supine BP (after at least 5 minutes of supine rest):
- Systolic blood pressure: 90 - 140 mmHg.
- Diastolic blood pressure: 40 - 90 mmHg.
- Supine pulse rate after at least 5 minutes of rest: 45 - 90 bpm.
- Signs and/or symptoms of a clinically relevant acute illness in the four-week period prior to screening.
- Veins unsuitable for intravenous puncture or cannulation on either arm (e.g. veins that are difficult to locate, access or puncture, veins with a tendency to rupture during or after puncture).
- Known hypersensitivity to any medicines administered in the trial.
- Use of prescription medications (other than their usual insulin) within 14 days or 10 half-lives (whichever is longer) prior to Day 1, or any over-the-counter (OTC) medication (including multivitamin, herbal, or homeopathic preparations, excluding hormonal contraception, hormone-replacement therapy, and/or an occasional dose of acetaminophen) within 7 days prior to Day 1 of the dosing period.
- Administration of antibiotics 7 days prior to the admission for the study or plan to take antibiotics during the study.
- Treatment with an investigational drug within four weeks prior to admission or having participated in more than three investigational drug studies within one year prior to admission.
- Positive test results for alcohol or drugs of abuse at screening and on Day -1.
- Presence or history of drug or alcohol abuse in the last 5 years, or inability to refrain from alcohol use from 48 hours before screening, dosing and each scheduled visit until the end of the study. Alcohol abuse is defined as regular weekly intake of more than 14 units (for both males and females), using the following NHS alcohol tracker http://www.nhs.uk/Tools/Pages/drinks-tracker.aspx.
- Use of tobacco in any form (e.g., smoking or chewing) or other nicotine-containing products in any form (e.g., gum, patch, electronic cigarettes) within 3 months prior to the planned first day of dosing.
- Positive test for Hepatitis B surface antigen (HBsAg), Hepatitis C antibody (HCV Ab), or human immunodeficiency virus antibody (HIV Ab) at screening.
- Has a legal or mental incapacity or language barriers precluding adequate understanding, co-operation, and compliance with the study requirements at screening.
- Any circumstances or conditions, which, in the opinion of the Investigator, may affect full participation in the study or compliance with the protocol.
- An inability to follow a standardized diet and meal schedule or inability to fast, as required during the study.
- Prior screen failure (where the cause of the screen failure is not deemed to be temporary), participation, or enrolment in this study. Subjects who initially failed due to temporary non-medically significant issues are eligible for re-screening once the cause has resolved.
- Objection by the General Practitioner (GP) to the subject entering the study.
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Richmond Pharmacology Ltd. 1a Newcomen St, London Bridge
London, SE1 1YR
About this study
Official title: A Single Centre, Placebo Controlled, Phase I Study to Evaluate the Effect of Glucose and Moxifloxacin on Cardiac Repolarisation in Male and Female Patients With Type I Diabetes.
High blood glucose levels (hyperglycaemia) and Moxifloxacin (a commonly used antibiotic) have both been shown independently to affect heart activity in healthy volunteers as recorded by ECG. i.e. Both cause prolongation of the QTc interval which is a measure of the time between the start of the Qwave and the end of the Twave during a heartbeat cycle. In this study, the investigators want to find out whether moxifloxacin and hyperglycaemia cause QTc prolongation in Type 1 diabetic patients. The investigators also want to assess whether C-peptide (a fragment if insulin normally found in the blood but not present in the blood of Type 1 diabetics) has the opposite effect on heart activity i.e it shortens the QTc interval will reverse the effect of QTc prolongation in Type 1 diabetes as this may be useful for preventing 'dead in bed' syndrome also known as 'Sudden Cardiac Death' which is more common in diabetic patients compared to healthy volunteers.
Read the detailed description
The investigators previous research (Taubel et al., 2013) has shown that in healthy individuals glucose by itself can prolong (with C-peptide antagonising the effects) the QT interval, which has long been used as a clinical index of the duration of ventricular repolarisation. This observation warrants serious attention because it suggests that high glucose levels by themselves may be pro-arrhythmogenic. To investigate whether glucose has an effect on cardiac repolarisation, it would be advantageous to test this in an environment uncomplicated by C-peptide. In order to elucidate the effects of glucose on the QTc in the absence of C-peptide, the investigators will use diabetic patients who are no longer able to release endogenous C-peptide. This will allow better understanding to whether (1) the well established QTc prolongation caused by moxifloxacin is exaggerated by elevated levels of blood glucose, which would be important for evaluating the risk in diabetic patients using an IKr blocking drug such as moxifloxacin, and (2) to investigate whether C-peptide substitution will reverse or attenuate the effect in the presence of moxifloxacin. Using the conditions of a formal TQT study, the investigators would also want to confirm the QTc prolonging effects described in Gordin et al. (2008) and whether in this setting C-Peptide substitution will reverse or attenuate the glucose effect on QTc.
This will be a phase I, single centre, randomised, placebo-controlled, open-label, crossover study designed to evaluate the effect of glucose and C-peptide on cardiac repolarisation using a hyperglycaemic clamp and a single 400 mg dose of moxifloxacin as a positive control in non-elderly male and female patients with type I diabetes. The results from this study will form the basis for decisions for future studies.
This study will be performed in compliance with the protocol, ICH GCP and applicable regulatory requirements including EU GMP requirements for investigational medicinal product(s) (IMPs).
- Conditions
- Diabetes
- Being tested
- Moxifloxacin, hyper-glycaemic clamp
- Keywords
- Hyperglycaemia, Moxifloxacin, QTc prolongation, C-peptide, Dead in bed syndrome
- Medical subject headings
- Diabetes Mellitus, Hyperglycemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MoxifloxacinDrug
Also called Avelox®
- a single oral dose of 400mg Moxifloxacin plus a hyper-glycaemic clamp for 4 hours
- a single oral dose of 400mg Moxifloxacin plus C-peptide
- a single oral dose of 400mg Moxifloxacin
- placebo
Oral doses of placebo and moxifloxacin will be administered by a Research Physician or Pharmacy staff member between 08:00 a.m. and 10:00 a.m.
hyper-glycaemic clampOther
Also called glucose infusion, glucose clamp
a hyper-glycaemic clamp only for 2 hours followed by a hyper-glycaemic clamp plus C-peptide for 2 hours
| Study group | Role | What they receive |
|---|---|---|
| hyper-glycaemic clamp: | Experimental | hyper-glycaemic clamp: intra-venous Glucose as an initial bolus of 250mg/kg followed by a variable maintenance infusion for 4 hours Receives: Other: hyper-glycaemic clamp |
| Moxifloxacin | Experimental | Single oral dose of 400 mg Moxifloxacin Receives: Drug: Moxifloxacin |
| Placebo | Placebo comparator | Placebo Receives: Drug: Moxifloxacin |
What is being measured
The primary outcome is the main question the study is designed to answer.
ECG Analysis
- The paired PK and QTc interval parameters pre-dose compared to post-administration of glucose. Clinically significant ECG morphology and interval changes from baseline.
- The effect on QTc will be calculated using concentration-effect analysis.
Measured: 1, 2, 3 Days
Secondary outcomes (1)
Proportion of Participants with Adverse Events
Haematology, chemistry and urinalysis will be used to assess the proportion of subjects with clinically significant changes in laboratory safety tests.
Electrocardiogram (ECG) will be used to assess the proportion of subjects with morphological heart and/or heart rhythm abnormalities.
PR, QRS, QT and QTc intervals will be used to assess the proportion of subjects with clinically significant changes in ECG time intervals.
Systolic blood pressure, diastolic blood pressure, heart rate, respiratory rate and temperature will be used to assess the proportion of subjects with clinically significant changes in vital signs.
All of the above will be used to measure the incidence of adverse events (AEs).
Measured: 1, 2, 3 Days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Nov 2013 (estimated)
- Study start10 Feb 2019
- Primary completion31 Dec 2020
- Study completion31 Dec 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for DiabetesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Richmond Research Institute
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Richmond Pharmacology Limited
- Responsible party
- Sponsor
- Investigators
- Jorg Taubel, MD FFPM, Principal investigator, Richmond Pharmacology Limited
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01984827
- Sponsor's protocol ID
- RPL-01-12
- Other IDs
- 2013-001612-30, C12061
- Status last verified
- Apr 2021
- First submitted
- 8 Nov 2013
- Last updated
- 5 May 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Taubel J, Lorch U, Ferber G, Singh J, Batchvarov VN, Savelieva I, Camm AJ. Insulin at normal physiological levels does not prolong QT(c) interval in thorough QT studies performed in healthy volunteers. Br J Clin Pharmacol. 2013 Feb;75(2):392-403. doi: 10.1111/j.1365-2125.2012.04376.x.
PubMed 22775199Taubel J, Naseem A, Shakeri-Nejad K, Dingemanse J, Ferber G and Camm A. J. Comparison of digital 12-lead ECG and digital 12-lead holter ECG recordings in healthy male subjects. Clinical Pharmacology and Therapeutics / 89:Supplement 1 (2011) / S11.
Taubel J, Pimenta D, Cole ST, Graff C, Kanters JK, Camm AJ. Effect of hyperglycaemia in combination with moxifloxacin on cardiac repolarization in male and female patients with type I diabetes. Clin Res Cardiol. 2022 Oct;111(10):1147-1160. doi: 10.1007/s00392-022-02037-8. Epub 2022 May 21.
PubMed 35596784
Study at a glance
From the registry record, last updated by the sponsor on 5 May 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single Centre, Placebo Controlled, Phase I Study to Evaluate the Effect of Glucose and Moxifloxacin on Cardiac Repolarisation in Male and Female Patients With Type I Diabetes.
- ClinicalTrials.gov ID
- NCT01984827
- Acronym / sponsor ID
- RPL-01-12
- Conditions
- Diabetes
- Keywords
- Hyperglycaemia, Moxifloxacin, QTc prolongation, C-peptide, Dead in bed syndrome
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Richmond Research InstituteIndustry (pharma, biotech, devices)
- Collaborators
- Richmond Pharmacology Limited
- Study start
- 10 Feb 2019 (actual)
- Primary completion
- 31 Dec 2020 (actual)
- Study completion
- 31 Dec 2020 (actual)
- First posted
- 15 Nov 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
High blood glucose levels (hyperglycaemia) and Moxifloxacin (a commonly used antibiotic) have both been shown independently to affect heart activity in healthy volunteers as recorded by ECG. i.e. Both cause prolongation of the QTc interval which is a measure of the time between the start of the Qwave and the end of the Twave during a heartbeat cycle. In this study, the investigators want to find out whether moxifloxacin and hyperglycaemia cause QTc prolongation in Type 1 diabetic patients. The investigators also want to assess whether C-peptide (a fragment if insulin normally found in the blood but not present in the blood of Type 1 diabetics) has the opposite effect on heart activity i.e it shortens the QTc interval will reverse the effect of QTc prolongation in Type 1 diabetes as this may be useful for preventing 'dead in bed' syndrome also known as 'Sudden Cardiac Death' which is more common in diabetic patients compared to healthy volunteers.
Detailed description
The investigators previous research (Taubel et al., 2013) has shown that in healthy individuals glucose by itself can prolong (with C-peptide antagonising the effects) the QT interval, which has long been used as a clinical index of the duration of ventricular repolarisation. This observation warrants serious attention because it suggests that high glucose levels by themselves may be pro-arrhythmogenic. To investigate whether glucose has an effect on cardiac repolarisation, it would be advantageous to test this in an environment uncomplicated by C-peptide. In order to elucidate the effects of glucose on the QTc in the absence of C-peptide, the investigators will use diabetic patients who are no longer able to release endogenous C-peptide. This will allow better understanding to whether (1) the well established QTc prolongation caused by moxifloxacin is exaggerated by elevated levels of blood glucose, which would be important for evaluating the risk in diabetic patients using an IKr blocking drug such as moxifloxacin, and (2) to investigate whether C-peptide substitution will reverse or attenuate the effect in the presence of moxifloxacin. Using the conditions of a formal TQT study, the investigators would also want to confirm the QTc prolonging effects described in Gordin et al. (2008) and whether in this setting C-Peptide substitution will reverse or attenuate the glucose effect on QTc.
This will be a phase I, single centre, randomised, placebo-controlled, open-label, crossover study designed to evaluate the effect of glucose and C-peptide on cardiac repolarisation using a hyperglycaemic clamp and a single 400 mg dose of moxifloxacin as a positive control in non-elderly male and female patients with type I diabetes. The results from this study will form the basis for decisions for future studies.
This study will be performed in compliance with the protocol, ICH GCP and applicable regulatory requirements including EU GMP requirements for investigational medicinal product(s) (IMPs).
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| hyper-glycaemic clamp: | Experimental | Other: hyper-glycaemic clamphyper-glycaemic clamp: intra-venous Glucose as an initial bolus of 250mg/kg followed by a variable maintenance infusion for 4 hours |
| Moxifloxacin | Experimental | Drug: MoxifloxacinSingle oral dose of 400 mg Moxifloxacin |
| Placebo | Placebo comparator | Drug: MoxifloxacinPlacebo |
Who may qualify
- Ages
- 20 to 64 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (26 listed)
- A subject will be eligible for inclusion in this study only if all of the following criteria apply:
- Subject is a male or female with a confirmed diagnosis of C-peptide deficiency Type 1 diabetes mellitus, HbA1c levels of ≤ 60 mmol/mol and 20 - 64 years of age (inclusive) at screening.
- Healthy (apart from the confirmed diagnosis of C-peptide deficiency Type 1 diabetes mellitus) on the physical examination at screening and at admission on Day -1.
- Body mass index (BMI) between 18 and 30 kg/m2 (inclusive) at screening and at admission on Day -1, body weight at least 48 kg.
- Haematology, biochemistry and urinalysis test results within the normal range to a clinically relevant extent at screening and at admission.
Key exclusion criteria (42 listed)
- A subject will not be eligible for inclusion in this study if any of the following criteria apply:
- History or clinical evidence of Type 1 diabetes mellitus related secondary complications in particular autonomic neuropathy, rhythm disturbances, post medical history of syncope and potassium abnormalities.
- 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 (appendectomy and herniotomy allowed, cholecystectomy not allowed).
- History or clinical evidence of 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 the past one month.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MoxifloxacinAlso: Avelox®1. a single oral dose of 400mg Moxifloxacin plus a hyper-glycaemic clamp for 4 hours 2. a single oral dose of 400mg Moxifloxacin plus C-peptide 3. a single oral dose of 400mg Moxifloxacin 4. placebo Oral doses of placebo and moxifloxacin will be administered by a Research Physician or Pharmacy staff member between 08:00 a.m. and 10:00 a.m. | Drug | Moxifloxacin, Placebo |
| hyper-glycaemic clampAlso: glucose infusion, glucose clampa hyper-glycaemic clamp only for 2 hours followed by a hyper-glycaemic clamp plus C-peptide for 2 hours | Other | hyper-glycaemic clamp: |
Primary outcome
ECG Analysis
Time frame: 1, 2, 3 Days
* The paired PK and QTc interval parameters pre-dose compared to post-administration of glucose. Clinically significant ECG morphology and interval changes from baseline. * The effect on QTc will be calculated using concentration-effect analysis.
1 secondary outcome
Proportion of Participants with Adverse Events
Time frame: 1, 2, 3 Days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 May 2021.
- Background: PubMed 22775199Taubel J, Lorch U, Ferber G, Singh J, Batchvarov VN, Savelieva I, Camm AJ. Insulin at normal physiological levels does not prolong QT(c) interval in thorough QT studies performed in healthy volunteers. Br J Clin Pharmacol. 2013 Feb;75(2):392-403. doi: 10.1111/j.1365-2125.2012.04376.x.
- BackgroundTaubel J, Naseem A, Shakeri-Nejad K, Dingemanse J, Ferber G and Camm A. J. Comparison of digital 12-lead ECG and digital 12-lead holter ECG recordings in healthy male subjects. Clinical Pharmacology and Therapeutics / 89:Supplement 1 (2011) / S11.
- Derived from this study: PubMed 35596784Taubel J, Pimenta D, Cole ST, Graff C, Kanters JK, Camm AJ. Effect of hyperglycaemia in combination with moxifloxacin on cardiac repolarization in male and female patients with type I diabetes. Clin Res Cardiol. 2022 Oct;111(10):1147-1160. doi: 10.1007/s00392-022-02037-8. Epub 2022 May 21.
- Clincal Research OrganisationLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jorg Taubel, MD FFPM principal investigator
Richmond Pharmacology Limited
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Moxifloxacin and hyper-glycaemic clamp in people with Diabetes, run by Richmond Research Institute at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 26 inclusion and 42 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 May 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
ECG Analysis (time frame: 1, 2, 3 Days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01984827, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 May 2021.