Author: Oliver Jelley

Positive results in type 1 diabetes cell therapy study

All six people treated with engrafted islet cells in a clinical trial produced endogenous insulin (C-peptide) and had improved glycaemic control while reducing or eliminating insulin use, according to results presented at the American Diabetes Association’s 83rd Scientific Sessions. Vertex Pharmaceuticals Incorporated presented data on June 23 on all patients dosed in Parts A and B of its Phase 1/2 clinical trial of VX-880, an investigational stem cell-derived, fully differentiated islet cell therapy, in people with type 1 diabetes with impaired hypoglycaemic awareness and severe hypoglycaemic events (SHEs). Study participants treated with VX-880 had undetectable fasting C-peptide (endogenous insulin secretion) at baseline, a history of recurrent SHEs in the year prior to treatment and required an average of 34.0 units of insulin per day, according to the study. Following treatment, all six participants demonstrated endogenous insulin secretion, improved glycemic control as measured by HbA1c, improved time-in-range on continuous glucose monitoring, and reduction or elimination of exogenous insulin use. Patients with greater than 90 days of follow-up had elimination of SHEs in the evaluation period. One patient in Part A received a half-target dose of VX-880 and was followed for approximately nine months, at which time this patient received a second half dose, scientists reported. This patient subsequently withdrew consent (not related to adverse events [AEs]) and was therefore not evaluable for the primary endpoint, according to the study. These data represent a foundational advance in the potential treatment of T1D, bringing us one step closer to a potentially curative therapy for patients who are waiting. Dr Felicia Pagliuca, Disease Area Executive, Type 1 Diabetes at Vertex. Two patients treated with VX-880 had at least 12 months of follow-up after the last infusion and were therefore evaluable for the study’s primary efficacy endpoint of elimination of SHEs between Day 90 and Month 12 with a reduction of HbA1c (<7.0% or a decrease of at least 1% compared to baseline). Both of these patients met the criteria for the primary endpoint of the study, Vertex said. In addition, these two patients are insulin independent. Patient A1 had HbA1c of 5.3% at Month 21, compared to 8.6% at baseline, and Patient B1 had HbA1c of 6.0% at Month 12, compared to 7.6% at baseline. Both patients showed over 95% time-in-range based on continuous glucose monitoring. The ADA recommended target is ≥70%. The three additional patients in Part B, each administered the full target dose of VX-880 given as a single infusion, have follow-up between 29 and 90 days and have shown endogenous insulin secretion, reduction in HbA1c, improvements in glucose time-in-range, and reductions in daily exogenous insulin use. Their trajectory is consistent with that observed in the two patients with more than one year of follow-up at equivalent periods of follow-up after VX-880 infusion. VX-880 has been generally well tolerated in all patients dosed to date. The majority of AEs were mild or moderate, and there were no serious AEs related to VX-880 treatment. The most common AEs were dehydration, diarrhea, hypomagnesemia and rash. As previously reported, one subject had SHEs in the perioperative period. As a result of these safety and efficacy data in Parts A and B, the independent data review committee has recommended moving to Part C of the trial, which allows for concurrent dosing of patients at the full target dose of VX-880. Dr Felicia Pagliuca, Disease Area Executive, Type 1 Diabetes at Vertex, said: “These data represent a foundational advance in the potential treatment of type 1 diabetes, bringing us one step closer to a potentially curative therapy for patients who are waiting. These data are particularly meaningful in the context of our overall investigational T1D program, as these same VX-880 cells are the building blocks for our Phase 1/2 VX-264 cells-plus-device program, as well as our research-stage hypoimmune islet cell program.” Dr Trevor Reichman, from the Department of Surgery, University of Toronto, said: “The reproducible efficacy across multiple patients and endpoints, including the level of glucose control and the elimination of SHEs, observed in this trial is highly unusual in T1D patients treated with exogenous insulin, wherein only ~25% of people with T1D meet the recommended HbA1c target of 7.0%, and is truly remarkable. The normalization of HbA1c without the need for exogenous insulin one year after therapy with VX-880 is historic and offers hope that the transformative therapies the T1D community has been waiting for may finally become reality.” These data were presented during the American Diabetes Association 83rd Scientific Sessions Conference on June 23, 2023 in San Diego, California at 3.50pm PT as an oral presentation, ‘Glucose-Dependent Insulin Production and Insulin-Independence in Type 1 Diabetes from Stem Cell-Derived, Fully Differentiated Islet Cells: Updated Data from the VX-880 Clinical Trial’, as part of the ‘Designer Beta Cells’ symposium from 3.45pm to 5.15 pm PT.

Giving statins to people in hospital with COVID-19 shown to benefit those with diabetes

Using statins in hospital for people with COVID-19 and diabetes has been linked to reducing mortality rates by almost 60%, a recent study reveals. The research has also associated the use of statins with a 40% decrease in admissions to ICU and 55% less requirement for mechanical ventilation. The use of statins for individuals without diabetes who were in hospital with COVID-19, were not notably linked to any of the clinical outcomes being investigated. The co-author of the study, Doctor Prateek Lohia, commented: “the presence of diabetes mellitus was an important factor affecting this association between inpatient statins and clinical outcomes”. 922 people with COVID-19 were analysed divided into two groups dependant on whether they received statins in hospital, or not. Around 45% of these patients had pre-existing or a history of diabetes. Approximately 27.1% of the 922 individuals received statins in hospital, and 32.9% of the people with a history of diabetes received statins. The main statin medication used was Atorvastatin, given to 82% of the 922. Dr Lohia said: “Our findings indicate that the continuation of statin therapy seems to be safe in hospitalized COVID-19 patients who were using statins as home medications, unless they present with one of the contraindications for statin administration, although randomized control trials are warranted to provide the best level of evidence.” This study, published in the journal Cardiovascular Diabetology, was built on previous work from Dr Lohia’s lab assessing the use of statins at home. She commented: “Building upon our previous work, this study identifies a reduction in the severe disease outcomes among antecedent statin users who were continued on statins in the hospital, compared to those whose statins were discontinued in the hospital.”

Diabetes Technology Network-UK kickstarts webinar series

A new three-part educational webinar series aimed at exploring clinical novel systems has been launched last week. The first session took place on Wednesday, July 21, 2021, and covered the basic aspects of hybrid closed-loop systems. Hosted by the Diabetes Technology Network-UK (DTN-UK), the opening webinar discussed the details of systems available in the UK, key concepts of how they have worked and overviews of practical features relevant to using these methods in clinics. Consultant Diabetes and Endocrine Physician Dr Sufyan Hussain and Senior Diabetes Specialist Nurse Geraldine Gallen both shared their expertise on hybrid closed-loop systems in the first webinar. Attendees were encouraged to interact with the speakers in a live Q&A at the end of their talks. The three-part webinar series is part of a wider NHS hybrid-closed loop pilot and is open to all NHS healthcare professionals caring for people with type 1 diabetes. Details for the remaining two webinars will be announced soon. To access the first webinar, click here. Photo by Kaitlyn Baker on Unsplash

Hyperglycaemia increases the risk of COVID-19 mortality in people without diabetes by almost double, when compared to those with diabetes

According to recent study results, hyperglycaemia has been recognised as an “independent risk factor for mortality” for people with COVID-19. Hyperglycaemia has been found to pose nearly double the risk of mortality to people with COVID-19 who do not have diabetes, despite diabetes being distinguished as a risk factor for individuals with COVID-19. The study suggests that the mortality risk in people with COVID-19 who have been admitted to hospital can be adapted and improved using glucose control. The research surveyed data from 74,148 people with, and without, pre-existing diabetes who had tested positive for COVID-19 and were admitted to hospital. Statistics from one or more glucose measurement per individual were assessed to investigate and identify the link between hyperglycaemia and poor outcomes. A hyperglycaemic measurement during their time in hospital was associated with a higher risk of morality when compared to those who had glucose measurements that were within the “normal range”. The risk of mortality for people with pre-existing diabetes increased by 10.1% when they had a glucose measurement classified as hyperglycaemic. Whereas risk for individuals without pre-existing diabetes increased by 18.4%, the study said. Nevertheless, COVID-19 mortality is still higher in people with diabetes, whether hyperglycaemia was detected or not. Photo by CDC on Unsplash

Updated guidance now available for those with diabetes waiting for surgical treatment

Individuals with diabetes who are awaiting surgery can now access a digital brochure to best prepare themselves before undergoing a clinical procedure. The virtual brochure contains specialist advice on how to keep your glucose levels stabilised before surgery and signposts individuals to trustworthy websites that help people participate in regular physical activities, look after their feet and reduce their feelings of stress. The guidance has been produced by a team of clinicians, including doctors, anaesthetists and a psychologist, to support people with diabetes before surgical operations. Consultant Diabetologist Professor Gerry Rayman is the joint clinical lead for diabetes for the Getting It Right First Time (GIRFT) programme and has been heavily involved with the creation of this new leaflet. Additionally, Professor Rayman chairs the programme’s IP3D project supporting the improvements of perioperative pathways for those with diabetes. Typically, more than 300,000 people with diabetes undergo surgery every year but recently waiting times have extended due to the COVID-19 pandemic bringing all elective operations to a halt. With waiting lists at an all-time high, the digital guide will be given to most people with diabetes who are awaiting surgery by either primary or secondary care teams. To access the online brochure, click here. Photo by Piron Guillaume on Unsplash

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