insulin icodec for Diabetes, Autoimmune

Phase-Based Progress Estimates
2
Effectiveness
3
Safety
Novo Nordisk Investigational Site, New Dehli, India
Diabetes, Autoimmune+1 More
insulin icodec - Drug
Eligibility
18+
All Sexes
Eligible conditions
Select

Study Summary

A Research Study to Compare a New Weekly Insulin, Insulin Icodec, and an Available Daily Insulin, Insulin Degludec, Both in Combination With Mealtime Insulin in People With Type 1 Diabetes (ONWARDS 6)

See full description

Eligible Conditions

  • Diabetes, Autoimmune

Treatment Effectiveness

Effectiveness Progress

2 of 3
This is further along than 85% of similar trials

Other trials for Diabetes, Autoimmune

Study Objectives

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.

Week 26
Change in DTSQs (Diabetes Treatment Satisfaction Questionnaire) in total treatment satisfaction
Change in HbA1c (glycated haemoglobin)
Change in body weight
Change in fasting plasma glucose (FPG)
Week 52
Change in HbA1c
Week 57
Number of clinically significant hypoglycaemic episodes (level 2) (below 3.0 mmol/L (54 mg/dL), confirmed by BG meter)
Number of clinically significant hypoglycaemic episodes (level 2) (below 3.0 mmol/L (54 mg/dL), confirmed by BG meter) or severe hypoglycaemic episodes (level 3)
Number of nocturnal clinically significant hypoglycaemic episodes (level 2) (below 3.0 mmol/L (54 mg/dL), confirmed by BG meter) or severe hypoglycaemic episodes (level 3)
Number of severe hypoglycaemic episodes (level 3)
Week 26
Time in range 3.9-10.0 mmol/L (70-180 mg/dL) using continuous glucose monitoring (CGM) system, Dexcom G6
Time spent below 3.0 mmol/L (54 mg/dL) using continuous glucose monitoring (CGM) system, Dexcom G6
Time spent greater than 10 mmol/L (180 mg/dL) using continuous glucose monitoring (CGM) system, Dexcom G6
Week 52
Mean total weekly insulin dose

Trial Safety

Safety Progress

3 of 3
This is further along than 85% of similar trials

Other trials for Diabetes, Autoimmune

Trial Design

2 Treatment Groups

Insulin degludec + insulin aspart
1 of 2
Insulin icodec + insulin aspart
1 of 2
Active Control
Experimental Treatment

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.

Insulin icodec + insulin aspartinsulin icodec once a week in combination with 2-4 times daily injections of insulin aspart at meal times
Insulin degludec + insulin aspartinsulin degludec once a day in combination with 2-4 times daily injections of insulin aspart at meal times
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Insulin aspart
FDA approved
Insulin icodec
Not yet FDA approved

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: from week 50 to week 52
This trial has the following approximate timeline: 3 weeks for initial screening, variable treatment timelines, and roughly from week 50 to week 52 for reporting.

Closest Location

Novo Nordisk Investigational Site - San Antonio, TX

Eligibility Criteria

This trial is for patients born any sex aged 18 and older. There are 4 eligibility criteria to participate in this trial as listed below.

Mark “yes” if the following statements are true for you:
Male or female aged greater than or equal to 18 years at the time of signing informed consent.
Diagnosed with type 1 diabetes mellitus greater than or equal to 1 year prior to the day of screening.
Treated with multiple daily insulin injections (basal and bolus insulin analogue regimes) greater than or equal to 1 year prior to the day of screening.
HbA1c below10% at screening visit based on analysis from central laboratory.

Patient Q&A Section

Can diabetes, autoimmune be cured?

"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

Unverified Answer

What causes diabetes, autoimmune?

"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

Unverified Answer

What are the signs of diabetes, autoimmune?

"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

Unverified Answer

How many people get diabetes, autoimmune a year in the United States?

"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

Unverified Answer

What are common treatments for diabetes, autoimmune?

"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

Unverified Answer

What is diabetes, autoimmune?

"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

Unverified Answer

Have there been other clinical trials involving insulin icodec?

"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

Unverified Answer

What is the primary cause of diabetes, autoimmune?

"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

Unverified Answer

Does insulin icodec improve quality of life for those with diabetes, autoimmune?

"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

Unverified Answer

What are the latest developments in insulin icodec for therapeutic use?

"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

Unverified Answer

What does insulin icodec usually treat?

"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

Unverified Answer
Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
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