This trial is evaluating whether insulin icodec will improve 1 primary outcome and 12 secondary outcomes in patients with Diabetes, Autoimmune. Measurement will happen over the course of From baseline (week 0) to week 26.
This trial requires 580 total participants across 2 different treatment groups
This trial involves 2 different treatments. Insulin Icodec is the primary treatment being studied. Participants will all receive the same treatment. There is no placebo group. The treatments being tested are in Phase 3 and have had some early promising results.
"Diabetes and autoimmunity cannot be cured. However most adult cases of [type 1 diabetes](https://www.withpower.com/clinical-trials/type-1-diabetes) can be controlled, often adequately. It is possible to prevent type 1 diabetes in others by early recognition, exclusion of autoimmune risk factors, and careful insulin management to avoid hypoglycaemia and other complications such as autonomic neuropathy." - Anonymous Online Contributor
"Many factors such as viruses, diet, and genetic factors are believed to contribute to the development of diabetes. A combination of these factors leads to an autoimmune process." - Anonymous Online Contributor
"The signs and symptoms of diabetes are numerous, they occur throughout the day in all individuals having the disease, and vary greatly with age and gender. These symptoms are often unassociated with elevated glucose levels and therefore must be interpreted with confidence to enable effective management. Most importantly, they must be interpreted in the context of the patient's lifestyle to make decisions about treatment." - Anonymous Online Contributor
"The number of AITD patients in the USA has been decreasing for the past decade and this has been ascribed to the reduction in the use of thiazolidinedione in treatment. AITD is more prevalent in Japan, but an increasing percentage of diabetic patients with autoimmune thyroid manifestations has been reported in the US." - Anonymous Online Contributor
"Diabetes is one of the most common diseases in the United States, affecting 6–7% of the population. A total of 50% of these subjects are diagnosed with diabetes following a diabetes diagnosis or prior to diagnosis. The best approaches to diabetes treatment are the utilization of medications, lifestyle modification, proper diet and regular screenings for diabetes progression and complications.\n\n- American Medical Association (1979). "American Medical Association Journal." - Anonymous Online Contributor
"Diabetes is a disease of carbohydrate digestion, glucose regulation and insulin action. It was not known whether people with diabetes were also more likely to have autoimmune conditions during the period between the diagnosis of diabetes and the onset of symptoms. Now we can rule it out, because we found that about 23% of people with diabetes also had an autoimmune condition during the same period. People on statin therapy were more likely to be overweight, but did not have any advantage for autoimmune illnesses." - Anonymous Online Contributor
"There has been a number of clinical trials with icodec. Of the studies showing the effectiveness of an icodec-based treatment, the number were either case reports or studies with [no control groups] and only one of the studies showed the benefits to the patients. More research regarding icodec and its potential therapeutic benefits is warranted in diabetic cohorts." - Anonymous Online Contributor
"The findings support that autoimmune play a role in the pathogenesis of insulin resistance and that anti-CD3 antibodies may provide the most promising approach to treat T1D in terms of minimizing the effects of the drug over the long run on beta cells." - Anonymous Online Contributor
"Patients with diabetes and autoimmune disease who had previously failed conventional and intravenous insulin therapy saw improvement in HbA1c, hypoglycemia frequency, insulin requirements, and QoL as a result of treatment with icodec." - Anonymous Online Contributor
"Given the increased interest in insulin icodec, development of new insulin delivery strategies including icodecs will be of utmost interest. However, current safety precautions, including long-term, comparative studies, will have to be considered if new technology is to be adopted for use in humans." - Anonymous Online Contributor
"Icodevin should be used as the treatment of choice for diabetic ketoacidosis, because oral and parenteral insulin have similar efficacy. As for other uses, it may fail to work as well as insulin and may have side effects, so more rigorous investigations, such as a trial with a placebo, is necessary before its use is recommended." - Anonymous Online Contributor