Aim: This study aims to evaluate the effect of IMCY-0098 on the immune signature (treatment-specific biomarkers), and the effect of the study drug upon the preservation of beta-cell function in adult patients with Type 1 Diabetes. Further safety data will also be collected.
What will taking part involve?
Going to one of the study locations eleven times over the course of a year, including screening and randomisation visits.
The main study (for patients who are HLA DR4 positive) will include receiving a dose of either the treatment being studied, or a placebo every two weeks, from randomisation to week 10, six times in total.
The sub-study (for patients who are HLA DR4 negative, but HLA DR3 positive) will include receiving a dose of the treatment being studied, every 2 weeks from randomisation to week 10, six times in total.
For both the main study and sub-study, a ‘booster’ dose of the same treatment will be given 24 weeks after the first treatment.
Phase IIa, randomized, double-blind, placebo-controlled, dose comparison, multi-centre adaptive design clinical trial to evaluate the immune signature of the treatment with the Imotope™ IMCY-0098 and its effect on the preservation of beta-cell function in adult patients with a recent onset Type 1 diabetes
Eligibility to take part
1. Aged 18-44 years old.
2. Diagnosed with type 1 diabetes in the last 9 weeks.
3. Positive for 1 or more islet autoantibody.
The main study will include 84 patients. The sub-study will include 24 patients.
What will I be asked to do?
The main study will include 84 HLA DR4 positive patients, aged 18-44 who will be randomised 1:1:1 to treatment with 450 μg IMCY-0098 or 1350 μg IMCY-0098 or placebo, at 2-weekly intervals, for 6 treatments, with a booster treatment given at 24 weeks. Patients will undergo 11 study visits, including screening and randomisation visits, over a period of approximately 52 weeks.
The sub-study will include 24 HLA DR4 negative, HLA DR3 positive patients aged 18-44, who will be randomised 1:1 to treatment with 450 μg IMCY-0098 or 1350 μg IMCY-0098 at 2-weekly intervals, for 6 treatments, with a booster treatment given at 24 weeks.
Study locations
Churchill Hospital, Oxford
University of Wales Hospital, Cardiff
Addenbrooke’s Hospital, Cambridge
Royal London Hospital, London
Royal Victoria Infirmary, Newcastle
Royal Devon and Exeter Hospital, Exeter
Guy’s Hospital, London
St. Georges Hospital, London
Leeds General Infirmary
Leicester Royal Infirmary
Royal Infirmary, Edinburgh
Who is running this study?
The study is sponsored and funded by Imcyse SA.
Ver-A-T1D STUDY
Recruiting to November 2022
Aim: Verapamil, a known blood pressure lowering drug, has been shown recently to protect and strengthen beta cells and slows down beta cell destruction in Type 1 diabetes. The aim is to confirm the effect of 360mg Verapamil sustained release (SR) administered orally once daily (titrated over the first 3 months from 120 mg to 360 mg).
What will taking part involve?
Those who take part will be asked to attend a study visit for screening, then take a tablet once a day for 1 year which will either be Verapamil or a placebo.
There will be seven treatment visits and three phone visits during this time with different tests taken, and an optional follow up visit at 2 years.
A randomised, double-blind, placebo controlled, parallel group, multi-centre trial in adult subjects with newly diagnosed type 1 diabetes mellitus investigating the effect of Verapamil SR on preservation of beta-cell function (Ver-A- T1D)
Eligibility to take part
Age 18-45
Diagnosed with type 1 diabetes in the last 6 weeks
What will I be asked to do?
After signing the informed consent, you will be asked to come in for a screening visit to check if you are eligible for the study. If you are eligible, you will attend for a randomisation visit where it will be decided by chance which study medication you will receive (active or dummy). This is followed by 7 treatment visits (at the clinic), accompanied by 3 phone calls (phone visits). The amount of time you will spend at the clinic at each visit may vary. This is because the tests and checks will differ at each visit.
Study locations
Southmead Hospital, Bristol.
Queen Elizabeth Hospital, Birmingham.
Addenbrookes Hospital Cambridge,
University Hospital of Wales, Cardiff,
Guy’s Hospital (KCL), London,
Bart’s Hospital (QMUL), London,
Queen’s Medical Centre, Nottingham,
OCDEM, John Radcliffe Hospital, Oxford,
Royal Hallamshire Hospital, Sheffield,
Singleton Hospital, Swansea.
Who is running this study?
Study Sponsor: Medical University of Graz,
Medical University of Graz Department of Internal Medicine
Austria
Chief Investigator: Prof. Thomas Pieber, MD
Medical University of Graz
Co-Chief Investigator: Prof. Colin Dayan, MD
Cardiff University School of Medicine
Extod-Immune
Recruiting to: December 2023
Summary
The project is for patients with type-1 diabetes (diagnosed within 1 year) who are not physically active. Patients will be asked to undertake an exercise intervention for 12 weeks in their own home, followed by a 12-week control period with no prescribed exercise.
Aim
The aim of this project is to investigate the impact of a remotely monitored exercise intervention on immune driven disease activity in patients with a recent diagnosis of type-1 diabetes vs. standard care with no prescribed exercise.
Full Study title: Can a remotely monitored, home-based exercise intervention for individuals with type-one diabetes reduce immune-driven disease activity?
Eligibility to take part
Inclusion Criteria
Age: 18-60 years old
Clinical diagnosis of T1D made within 11 months.
Self‐administering their insulin as part of a multiple dose injection regime or insulin pump therapy.
Both participant and physician feel that they are able to exercise safely.
Patient is able to estimate carbohydrate content of meals
Patient is willing to test glucose and adjust insulin and carbohydrate doses accordingly
Patients will be able to recognise hypoglycaemic symptoms before capillary blood glucose falls to 3.5mmol/L
Exclusion Criteria
Uncontrolled blood pressure
Pregnancy or planning pregnancy
Adhering to the current recommended physical activity guidelines (> 150 minutes)
Additional health conditions that might put the participant at risk for this study e.g. cardiac disease, active proliferative diabetic retinopathy, autonomic neuropathy and/or a history of severe hypoglycaemia requiring third party assistance within the last 3 months. Any other condition (medical or psychological) that is deemed inappropriate will be at the PI’s discretion.
Unable to provide full informed consent.
What will I be asked to do? If you agree to take part in the study and meet the inclusion criteria after our initial screening (conducted remotely, including a saliva sample), you will be invited to attend your local Clinical Research Facility (CRF) on four separate occasions over a 36-week period. On each visit, we will carry out a medical review and measure your weight, blood pressure, pulse and draw a blood sample. We will also ask you to wear a flash glucose monitor for 2 weeks. You will then be
You will then be randomly allocated to either a home-based exercise or control group (undertake your usual level of exercise without any extra support from us) between weeks 1-12. Following a 12-week break from the study, you will be allocated to the other group in weeks 24-36. Please see a simplified study schematic below:
The exercise is safe for people with type-1 diabetes to undertake at home. Details are outlined below:
For weeks 1-2 of the intervention, we will ask participants to:
Perform a low intensity warm up for 2-minutes
Perform 6 x 1-minute high intensity intervals (bodyweight exercises), interspersed with 1-minute rest intervals (11 minutes). You will be asked to exercise at an intensity that elicits 80% of your maximum heart rate.
Total exercise time will be 13 minutes.
For weeks 3-4 of the intervention, this will increase to 8 intervals (total exercise time will be 17 minutes).
For weeks 5-12 of the intervention, this will increase to 10 intervals (total exercise time will be 21 minutes).
Who is running this study? Sponsor: University of Birmingham,
Chief Investigator: Dr Alex Wadley
Funder: The Rosetrees Trust
Study site:
Queen Elizabeth Hospital, University Hospitals Birmingham
Musgrove Park Hospital, Somerset NHS Foundation Trust
School of Sport and Exercise Sciences, Liverpool John Moors University
MELD-ATG
Recruiting to: Nov 2022
Aim People develop Type 1 diabetes (T1D) because their immune system, the part of the body which helps fight infections, mistakenly attacks and destroys the insulin-producing cells in the pancreas (beta cells). When the immune system destroys these cells, the body’s ability to produce insulin decreases, blood glucose levels run high, and T1D develops.
At the time of diagnosis of T1D, there are usually a small number of beta cells (10-20%) left in the pancreas, which still produce small amounts of insulin. We call this level of activity “beta cell function”. Most people with T1D will eventually stop producing insulin themselves. This may occur rapidly in a few months, or more slowly over several years. However, the longer people with T1D can produce their own insulin, the better it is for the control of blood glucose levels and to avoid long-term complications.
Previous research has shown that a drug called anti-thymocyte globulin (ATG) may help prevent the immune system from attacking and destroying the insulin-producing beta cells. In the MELD-ATG trial, we are looking for the minimum effective low doseofATG in young people newly diagnosed with T1D that:
Can slow the decline of beta cell function and preserve the body’s own insulin production
Has manageable side effects
What Will Taking Part Involve?
Participation will involve 8-10 hospital/clinic visits over about 13 months, and some at-home collections. Most visits take 1-4 hours. Treatment is given over two consecutive days and includes one overnight stay for most participants.
Full Study title Phase II, dose ranging, efficacy study of anti-thymocyte globulin (ATG) within 6 weeks of diagnosis of type 1 diabetes (T1D)
Eligibility to take part 1. Be aged ≥5 years to ≤25 years at time of written informed consent/assent
(NOTE: Currently recruiting 12-25yrs. Recruitment will open to lower age range following safety review of first 10 participants aged 12-17 who have received an active dose of ATG).
2. Have been diagnosed with T1D within 3–9 weeks of planned treatment day 1
What will I be asked to do? (in detail)
Screening visit (duration 2 hours)
After signing the Consent Form, you will be invited for a screening visit to see if you are eligible for the trial. We will ask about your diabetes diagnosis, medical history, and recent medications and vaccinations. You will have blood samples taken which include tests to check you are fit and well, and to screen for T1D related auto-antibodies and c-peptide levels.
Baseline visit (duration 4 hours) – fasted
If you are eligible to take part, you will have a baseline visit no more than 3 weeks after the screening visit. We will do a number of assessments including height/weight, a physical exam, blood pressure, heart rate, temperature/respiratory rate, review of any recent changes in health and medications and a mixed meal tolerance test (MMTT).
Treatment visit (duration 2 days)
If you are fit and well, you will have a treatment visit no more than 9 weeks from T1D diagnosis. Most participants will need an overnight stay for this visit, as there is no gap between treatment days 1 and 2. You will be able to eat and drink and give your insulin, as normal.
Treatment will be assigned in a random way (by chance), much like flipping a coin, by a central computer programme. This treatment will be either:
Active drug (a low dose of ATG)
Placebo (dummy drug)
Neither you nor your research team will know which treatment you are given but overall 3 out of 4 people will get the active treatment.
Treatment day 1
A nurse or doctor will talk to you about your health.
An intravenous cannula will be inserted, through which your trial treatment will be given
Pre-treatment medications (an antihistamine, an anti-inflammatory and paracetamol) will be given. Some are given orally and others through the cannula. These medications are a precaution because some people can react to the trial treatment (see section 1.12, for possible side effects)
Trial treatment infusion will take at least 12 hours
Blood samples will be collected
Vital signs (blood pressure, heart rate, oxygen saturation, respiratory rate, and temperature) will be checked throughout.
Treatment day 2
You will start your second trial treatment infusion at least 12 hours after completing the first. With the exception of the trial infusion which will only last 8 hrs, day 2 is the same as day 1, including pre-treatment medications, collecting blood samples, and measuring vital signs. Where possible, your intravenous cannula will be kept in place and used again on day 2. You will be able to go home after the infusion, once your research team agrees you are fit and well enough to do so.
Follow up visits
You will have 6 follow up visits at the hospital/clinic during the 12 months after finishing the trial treatment.
1 week after treatment (duration 1 hour)
2 weeks after treatment (duration 1 hour)
Your doctor or nurse will also be in contact (e.g. by phone) between the 2- and 4-week visits to discuss any changes in your health
4 weeks after treatment (duration 1 hour)
3 months after treatment (duration 4 hours) – fasted to include MMTT
6 months after treatment (duration 4 hours) – fasted to include MMTT
12 months after treatment (duration 4 hours) – fasted to include MMTT
Visits will include medical review, height/weight, vital signs, blood samples and for visit 3, 6 and 12 a MMTT
Home collection
You will also be asked to collect the following samples at home. The research team will go over these to ensure you know what to do:
Dried blood spots
Collection of dried blood spot samples (via a small finger prick) and blood glucose measurements, before and after a liquid meal (like the milkshake drink for the mixed-meal tolerance test).
Urine and stool samples
Collection of urine and stool samples at home within 1 week before or after the baseline, 3, 6- and 12-month follow up visits.
Trial diary
A short trial diary to complete at home following trial treatment. This will cover things like taking any medications and describing any possible side effects.
Continuous glucose monitoring (CGM)
Use a CGM device (provided by the study) for 14 days after each of the 3-, 6- and 12-month follow up visits, to measure blood glucose levels 24 hours a day.
Who is running this study? (Sponsor, CI, Funder, the study hospital(s) for visit etc.) MELD-ATG is coordinated by the University of Cambridge, UK, on behalf of the sponsor (University Hospital Leuven [UZ Leuven], Belgium).
The trial is part of a large research group called INNODIA (An innovative approach towards understanding and arresting Type 1 diabetes; www.innodia.eu). INNODIA brings together diabetes experts from across the UK and Europe, and aims to better understand the reasons why T1D develops and how it could be prevented.
MELD-ATG is funded by the Innovative Medicines Initiative 2 Joint Undertaking (grant agreement 115797). This receives support from the EU’s Horizon 2020 research and innovation programme and European Federation of Pharmaceutical Industries and Associations (EFPIA), Juvenile Diabetes Research Foundation and the Leona M. and Harry B. Helmsley Charitable Trust.
CFZ533 Study
Recruiting to: June 2024
Aim Clinical study of a new medication called CFZ533 (or iscalimab) in children and young adults aged 6-21 years with newly diagnosed Type 1 diabetes. By administering CFZ533 soon after T1DM starts, it is thought that it may be possible to slow or stop destruction of the remaining insulin-producing beta cells in the pancreas, and so preserve remaining insulin production.
What will taking part involve? • After an initial screening visit to collect data, you will be asked to attend a hospital visit every 4 weeks for around a year. • You will receive either the CFZ533 drug or a dummy drug (also known as ‘placebo’), with the first dose being given by intravenous injection and subsequent doses being given subcutaneously, decided at random by a special computer programme. • This will be ‘blinded’ which means no one knows if its CFZ533 or placebo (though this can be found out in an emergency). • You will be assessed during the study in several ways: physical examinations, blood and urine samples, study diaries, continuous glucose monitoring and tests to see how well the body deals with a meal.
Contact the study directly: Please see the CFZ533X2207 study page on the Type 1 Diabetes UK Consortium website – once on the T1D UK website, you can request further information about the study by clicking the ‘get involved’ button. (Please be reassured that requesting further information does not commit you to taking part in the study).
Full Study Title Investigator- and subject-blinded, randomized, placebo-controlled study to evaluate safety, tolerability, pharmacokinetics and efficacy of CFZ533 in pediatric and young adults with new onset type 1 diabetes mellitus (T1DM) Eligibility to take part The research team will check eligibility carefully before enroling a participant in to the study. Some of the main criteria are listed below:
Age 6-21 years
Body weight range 20-125 Kg
Able to have first dose of study medication within 56 days of inital T1DM diagnosis (may be extended to 100 days in specific circumstances)
What will I be asked to do? Adult participants will be asked to provide their informed consent before starting the study. Where a participant is under 16 years, they will be asked to provide assent, and their parent/guardian will be asked to provide informed consent on the participant’s behalf. The study has an initial screening and baseline period where the doctors check that a participant is eligible, and collect some initial data. The treatment period (when study drug is taken) comes after this and will last for around a year, with hospital visits every 4 weeks. After the treatment period is over, no more study drug is taken but some further follow-up visits at the hospital will happen (follow-up will last for up to 2 years after finishing treatment) – these visits will be monthly for the first 4 months and then every 6 months. Participants in the study will get either CFZ533 or a dummy drug (also known as ‘placebo’) and this will be ‘blinded’ which means that no one knows if its CFZ533 or placebo (though this can be found out in an emergency). It will not be possible to choose between CFZ533 and placebo as this will be decided at random (by chance) by a special computer program. The first dose will be given by intravenous injection, then all other doses will be done by subcutaneous injection. Participants can continue to take their regular insulin therapy throughout the study. Assessments during the study will include things such as: physical examinations, blood and urine samples, study diaries, continuous glucose monitoring, tests to see how well the body deals with a meal.
Study locations Alder Hey
Who is running this study? This study is being organised and funded by Novartis Pharma AG.
DIABETIC TWIN STUDY
Currently Recruiting
Aim: To study the influence of environment and genes on the onset of type 1 diabetes using identical twins.
What will taking part involve?
You will be asked to give a blood sample and a mouth swab sample, and you will be asked about your health
Contact the study directly:
Call: 020 7882 2365 Dr Mohammed Hawa, Study Manager Email: m.i.hawa@qmul.ac.uk
