1206659 / ADDRESS-2

A Blinded Long-term Extension Study to Evaluate the Safety and Efficacy of Pioglitazone(AD-4833 Sustained Release 0.8 mg Daily) to Slow the Progression of Cognitive Decline inSubjects Who Have Completed the AD-4833/TOMM40_301 Study With Diagnosis of MildCognitive Impairment Due to Alzheimer Disease (Study due to close 31/12/2018)

1207681 / TrialNet Natural History Study

TrialNet Natural History Study of the Development of Type 1 Diabetes. Phase 1,2 and 3. (Study due to close 01/09/2019)

 

1208687 / Effects of Intermittent Compression on the hand or foot

Phase III, double-blind, placebo-controlled, multicenter, randomized study of pracinostat in combination with azacitidine in patients ≥18 years with newly diagnosed acute myeloid leukemia unfit for standard induction chemotherapy

1308826 / Genetic Beta Cell Research Bank inc Extension

Genetic Beta Cell Research Bank inc Extension (Study due to close 18/11/2022)

1311863 / iDEND

iDEND (Neuropsychological assessment of patients known to have iDEND neonatal diabetes) (Study due to close 31/12/2017)

1407957 / Type 1 Diabetes, Immunology, Genetics and endogenous Insulin     production

Type I diabetes occurs when an individual loses the ability to make enough insulin to control their blood sugar levels.  They need insulin injections to replace the insulin production that has been lost. Traditionally people with T1D are thought to make none of their own insulin after diagnosis, but we have recently identified that there are some people who have T1D but go one making insulin for many years. We would like to explore this in more depth and understand why some people with T1D go on making insulin and some do not. This will help us understand the causes of T1D and may help work out ways to protect this remaining insulin production, with improved blood sugar control, and reduced long term complications of diabetes. (Study due to close 30/06/2018)

 1507116 / DIVA

Defining the molecular and physiological mechanisms of pancreatic islet dysfunction which lead to type 2 diabetes (Study due to close 04/02/2019)

1603221 / Randomised Double-Blind Crossover study of a DPP4 inhibitor, SGLT2 inhibitor and thiazolidinedione as third line therapy in patients with type 2 diabetes who have suboptimal glycaemic control on dual therapy with metformin and a sulphonylurea

The TriMaster trial is part of the larger MASTERMIND project which aims to help identify the most suitable treatment for patients with type 2 diabetes.

It is known that patients with type 2 diabetes vary greatly in how well they respond to different diabetes drugs and whether they develop side effects to particular medications. In this study the research team aims to identify subgroups of patients that respond well or poorly to third-line therapies based on particular clinical characteristics such as their BMI and renal function.

The current choice for non-injectable third-line therapy is between a DPP4 inhibitor, an SGLT2 inhibitor and a thiazolidinedione (TZD). However the decision of which treatment to choose lacks guidance on which patients will respond well or poorly to a particular therapy.

This study is a randomised double-blind crossover trial in patients with type 2 diabetes who have poor glucose control on two classes of drugs. Patients who meet the current NICE guidelines for the addition of a third-line drug will be invited to take the 3 different available therapies for 4.5 months each in random order. As these drugs work in different ways the research team will be able to test whether the different clinical characteristics affect whether they respond well to the drugs, and/or make them more likely to experience side effects. (Study due to close 31/01/2020)

1608298 / BAY 1193397

A randomized, single blind, threefold crossover, single center study to assess the safety and the effects of 1 mg and 5 mg BAY 1193397 in comparison to placebo on skin capillary blood flow and transcutaneous oxygen pressure after single dose in type II diabetic patients with peripheral artery disease (Study due to close 30/09/2018)

1701366 / The FoND Study

Assessing the effect of Food composition on postprandial insulin secretion in KCNJ11 Neonatal Diabetes (FoND study) (Study due to close 31/08/2018)

1703396 / StartRight

To assess whether blood tests, either alone or in combination with clinical features, can help us tell if a patient needs rapid insulin treatment and should be initially treated as Type 1 or Type 2 diabetes. We will combine results from this study and existing previous studies to produce a calculator, called a clinical probability model that will allow doctors and patients to combine information from clinical features and (where necessary) blood tests to accurately diagnose what type of diabetes a person has and therefore give the correct treatment. (Study due to close 30/09/2018)

1706442 / The use of near infra-red spectroscopy as a diagnostic tool to measure haemodynamic markers of the microvascular blood supply in bone tissue.

Near infrared spectroscopy (NIRS) uses similar technology to the commonly used devices that measure your pulse. It works by shining near infra-red light on a body part and measuring changes in the reflected light that scatters back. This can provide a measure of the concentration of haemoglobin (the part of blood that carries oxygen) in that body part.  Our project will investigate the suitability of using NIRS to specifically measure markers of the blood supply in bone tissue using simple and tolerable tests. This will include how much oxygen the blood in bone has (oxygenation), how quickly blood is delivered to bone (bone perfusion) and the volume of blood per unit mass of bone (blood volume).

This study aims to prove that NIRS tests are as accurate as existing MRI tests for measuring microvascular blood supply in bone tissue.  We also wish to use participants with and without type 2 diabetes mellitus (T2DM), and some participants who have had a recent fracture.  This will help us investigate whether NIRS can detect any differences in blood supply in the bone in those with T2DM.  This is because we know T2DM is a risk factor for low impact bone fractures.

This is important research as existing tests are not efficient at measuring blood supply to bone tissue, and also have more risks for the patient.  If successful, NIRS technology has the potential to become an inexpensive, fast and effective way to measure blood supply to bone that is safe for the participant.  This could be useful for future research and potentially when screening for, or diagnosing, common bone diseases like osteoporosis, poor fracture healing, arthritis and blood-bourne cancers like leukemia. (Study due to close 01/09/2019)

1706443 / Understanding beta-cell destruction through the study of EXtremely Early-onset Type 1 Diabetes (A Musketeers’ Memorandum study)

A study to assess clinical phenotype, beta cell function, genetics, and autoantibodies in Extremely Early Type 1 Diabetes (EET1D) to better understand the aetiology and progression of beta cell destruction in Type 1 diabetes (T1D) occurring in the first year of life.

As a study of a very rare disease (< 100 in UK) defined by genetics, it is adopted as a Musketeers’ Memorandum Study. (Study due to close 31/07/2020)

1712543 / A phase I, placebo controlled, double-blind, dose escalation clinical trial to evaluate the safety and immune responses of imcyse’s imcy-0098 in patients with recent onset type 1 diabetes.

A phase i, placebo controlled, double-blind, dose escalation clinical trial to evaluate the safety and immune responses of imcyse’s imcy-0098 in patients with recent onset type 1 diabetes. (Study due to close 31/12/2018)

1804570 / The Vascular actions of glucagon-like peptide-1 analogues and its mediators in people with type 2 diaBetes and diabetic rEtinopathy

Medications that mimic the natural gut hormone, glucagon-like peptide-1 (GLP-1) i.e. GLP-1 analogues, are used to aid sugar control in people with diabetes. Research suggests that these medications may also help improve blood vessel function. However, this research has focussed on people with well controlled diabetes with little or no diabetes-related small blood vessel complications (eg diabetic retinopathy). As individuals with type 2 diabetes (T2DM) and its related small blood vessel complications tend to have widespread health complications, eg heart disease, it is crucial to identity therapies that could protect blood vessels. This project will examine whether GLP-1 analogues have beneficial effects on blood vessel function in people with T2DM and diabetic retinopathy, and thus help us decide whether they may be a viable cardiovascular related treatment in this higher risk population.

We will recruit participants without diabetes; participants with T2DM and no complications and participants with T2DM and advanced retinopathy. We will assess the effects of GLP-1 mimetics (analogues) on (a) skin blood flow by injecting tiny amounts of the drugs into the skin and (b) in isolated vessels that we will obtain from small donated fat biopsies. Isolated vessels will be used to examine the mechanisms by which the GLP-1 analogues may act and whether any of these are blunted in vessels from participants with advanced retinopathy. We will measure markers of damage to the complex coating of the blood vessel wall (glycocalyx) in the blood from participants and from video images of the small blood vessels under the tongue to see if these vary with severity of retinopathy. Finally, we will explore whether the small blood vessel response to GLP-1 mimetics is associated with blood vessel function and structure in the back of the eye (retina), the area responsible for our sight. (Study due to close 31/10/2019)

1805634 / A 26-week Randomized, Double-blind, Controlled, Parallel-group, Multicenter Study to Evaluate the Efficacy and Safety of Sotagliflozin compared to Empagliflozin, and Placebo in Patients with Type 2 Diabetes Who Have Inadequate Glycemic Control on Dipeptidyl Peptidase 4 Inhibitor (DPP4(i)) With or Without Metformin

A 26-week Randomized, Double-blind, Controlled, Parallel-group, Multicenter Study to Evaluate the Efficacy and Safety of Sotagliflozin compared to Empagliflozin, and Placebo in Patients with Type 2 Diabetes Who Have Inadequate Glycemic Control on Dipeptidyl Peptidase 4 Inhibitor (DPP4(i)) With or Without Metformin (Study due to close 30/11/2018)

1810690 / Improving Clinical Care in Diabetes

Diabetes is one of the most common conditions in the world.  It is a condition that occurs when the amount of glucose (sugar) in the blood is too high. Insulin is a hormone that helps move glucose into our cells, where it is used as fuel for energy. The most common subtypes of diabetes are Type 1 and Type 2. People with Type 1 diabetes rapidly stop making their own insulin, so need insulin injections from diagnosis. In type 2 diabetes there often some resistance to the action of the insulin hormone, combined with a slow reduction in the bodies secretion over years which leads to an eventual need for insulin injections in most people with this condition.

Progression of both Type 1 and Type 2 diabetes is very variable. Many patients with type 1 diabetes keep making some insulin for many years, which makes keeping glucose levels well controlled much easier, whereas other lose all their own insulin secretion very rapidly. In type 2 diabetes some people will need insulin within a year or two of diagnosis, whereas others may not need insulin treatment for many decades. The reasons for the variation in progression seen in Type 1 and Type 2 diabetes are poorly understood.

This study aims to determine the predictors of differences in diabetes progression. This will help us understanding the reasons for variation in progression, which is important for developing new treatments to slow progression,  and help doctors identify those patients who will rapidly progress. These patients may benefit from closer monitoring, and use of alternative treatments that may slow progression.

For this study we will recruit 2000 participants with diabetes aged 16 years old and above.

We will record clinical features, biomarkers, medical history and diabetes treatment, and seek consent to use and store left-over samples taken as part of routine clinical care or in some cases take extra blood tests as part of the study. We will follow participants for up to 10 years after recruitment using electronic healthcare records where available and by re-contacting participants (by phone, email or in person) to collect data that will inform diabetes progression including treatment change and development of diabetes complications.

This will be a low cost study with minimal patient burden without the need for frequent face to face participant research visits. (Study due to close 01/03/2022)