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 *
* Due to open
Who is running this study?
The study is sponsored and funded by Imcyse SA.
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
Diabetic Twin Study: A study of epigenetics of type 1 diabetes using identical twins
Eligibility to take part
Identical twin pairs where one twin has type 1 diabetes and the other does not.
Who is running this study?
This study is being run by Queen Mary University of London. The Chief Investigator is Prof David Leslie.
It is funded by the Juvenile Diabetes Research Foundation.
Participants will be asked to visit St Bartholomew’s or The Royal London Hospital.
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
DROPLeT STUDY
Recruiting to December 2021
Aim: The aim of this research is to find out if older adults (aged over 30) with Type 1 diabetes have similar rates of progression to young adults (aged under 30).
What will taking part involve?
The study can be completed entirely from home, with the equipment sent to you and samples returned by post.
On 3 occasions you will be asked to fast overnight and collect blood samples before and after a liquid meal, and you will be asked to wear a Continuous Glucose Monitor for the year and optionally provide weekly fingerprick blood samples.
Contact the study directly:
Call 01392 408184 or email: rde-tr.DiabetesResearch@nhs.net
Defining The Rate Of Progression Of Late Onset Type 1 Diabetes
Eligibility to take part
Adults diagnosed with Type 1 diabetes within the previous 100 days.
Aged >30 at the time of Type 1 diabetes diagnosis OR (additional early onset Type 1 diabetes cohort) aged ≥18 and ≤30 at the time of Type 1 diabetes diagnosis*.
Insulin treated at the time of recruitment
Able and willing to provide informed consent.
* Clinical diagnosis of Type 1 diabetes mellitus.
What will I be asked to do?
The study takes 1 year to complete and everything can be done at home. On 3 occasions we will ask you to fast overnight (not to eat or drink anything except water for 8 hours) and collect finger prick blood samples both before and 90 minutes after drinking a liquid meal (a bit like a milk shake). We will also ask you to collect finger prick blood samples at home on 2 other occasions during the year. We will provide special packaging for you to post the samples to the central laboratory in Exeter. We will ask you to wear a continuous glucose monitor (CGM) &, in some people, we would like to be able to collect fingerpick samples up to weekly (these are optional extras).
Who is running this study?
The CI’s central coordinating team at the NIHR Exeter Clinical Research Facility are running the study. As all study procedures are carried out at home, with remote consent & telephone support from an experienced researcher, the study welcomes participants from all parts of England, Wales & Scotland.
Study packs are delivered to participant’s home by courier or tracked post, depending on participant preference, and returned to Exeter by the same means.
INNODIA
An innovative approach towards understanding and arresting type 1 diabetes
Recruiting
Summary Europe-wide study collecting blood samples and data from people newly diagnosed with type 1 diabetes and first degree relatives, aged 1-45 years.
Aim To develop a European infrastructure for the recruitment of newly diagnosed patients with type 1 diabetes (T1D) and unaffected family members, generating an unrivaled Bioresource for T1D discovery science.
Study outline INNODIA will collect blood samples and data throughout Europe from newly diagnosed patients with type 1 diabetes and first degree relatives of people with type 1 diabetes to study and understand the development and progression of the disease. INNODIA participants will form a large European resource (living Biobank) where their samples can be analysed and used by scientists and doctors to further their understanding and help design clinical trials to arrest or stop type 1 diabetes from occurring.
We plan to recruit 1500 children and adults aged between 1 and 45 years who have been diagnosed with T1D within the previous 6 weeks and 3000 first degree relatives of people with type 1 diabetes, also aged between 1-45 years who may be at risk of developing type 1 diabetes in the future.
Eligibility to take part Newly Diagnosed individuals with type 1 diabetes 1. Age 1-45 years 2. Diagnosed with type 1 diabetes in the last 6 weeks
First degree relatives of people with type 1 diabetes (unaffected family members) 1. Age 1-45 years 2. Have a first degree relative with type 1 diabetes (parent, child, full or half siblings) diagnosed less than 45 years of age
What will I/my child be asked to do? Newly Diagnosed individuals with type 1 diabetes The first visit will need to be within 6 weeks from when you were told you had diabetes and then at 3, 6, 12 and 24 months from diagnosis. At each visit you will have blood samples taken and a mixed meal tolerance test will be performed at visit 2 and at each visit until the end of the study. A mixed meal tolerance test can tell us how much insulin your body is still making.
Between the hospital visits and up until the end of the study we will ask for a tiny sample of your blood to be collected every 4 weeks by finger prick at home. We call these samples dried blood spots.
First degree relatives of people with type 1 diabetes (unaffected family members) We will ask you to attend a screening visit which will take about one hour, where a sample of your blood will be taken for genes and autoantibody testing.
The results of these tests will be available within 3 months. Depending on the results you may or may not be invited for further study visits.
If your autoantibody results are negative We will send you a health questionnaire, each year for 4 years or until the end of the study. We may ask you to provide further samples to compare results from people with type 1 diabetes and those from family members who do not have type 1 diabetes.
If your autoantibody results are positive We will invite you to come to hospital for a further 7 study visits over 4 years. At each visit we will take blood samples and perform an oral glucose tolerance test which can tell us how good your body is at making insulin.
Between the hospital visits and up until the end of the study we will ask for a tiny sample of your blood to be collected every 4 weeks by finger prick at home. We call these samples dried blood spots.
Study locations This study is open across around 21 sites across England and Scotland. For a full, current list of sites please see the INNODIA study website map.
Who is running this study? This study is sponsored by Cambridge University Hospitals NHS Foundation Trust and the University of Cambridge UK.
This project has received funding from the Innovative Medicines Initiative 2 Joint Undertaking under grant agreement No 115797 (INNODIA). This Joint Undertaking receives support from the European Union’s Horizon 2020 research and innovation programme and European Federation of Pharmaceutical Industries and Associations (EFPIA), Juvenile Diabetes Research Foundation (JDRF) and The Leona M. and Harry B. Helmsley Charitable Trust.
