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Insulin

insulin icodec for Type 1 Diabetes (ONWARDS 6 Trial)

Phase 3
Waitlist Available
Research Sponsored by Novo Nordisk A/S
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up from week 50 to week 52
Awards & highlights

ONWARDS 6 Trial Summary

This trial is comparing a new insulin to one that is already available, to see how well the new one works in people with type 1 diabetes.

Eligible Conditions
  • Type 1 Diabetes

ONWARDS 6 Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from week 50 to week 52
This trial's timeline: 3 weeks for screening, Varies for treatment, and from week 50 to week 52 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Change in Glycosylated Haemoglobin (HbA1c) at Week 26
Secondary outcome measures
Change in Body Weight
Change in Diabetes Treatment Satisfaction Questionnaire (DTSQs) in Total Treatment Satisfaction
Change in Fasting Plasma Glucose (FPG)
+14 more

ONWARDS 6 Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Insulin icodec + insulin aspartExperimental Treatment2 Interventions
insulin icodec once a week in combination with 2-4 times daily injections of insulin aspart at meal times.
Group II: Insulin degludec + insulin aspartActive Control2 Interventions
insulin 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 icodec
2021
Completed Phase 3
~700
insulin aspart
2002
Completed Phase 4
~9040

Find a Location

Who is running the clinical trial?

Novo Nordisk A/SLead Sponsor
1,514 Previous Clinical Trials
2,414,486 Total Patients Enrolled
Clinical Transparency (1452)Study DirectorNovo Nordisk A/S
7 Previous Clinical Trials
602,445 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is this a new or novel clinical trial?

"There are currently 21 ongoing clinical trials for insulin icodec in 169 cities and 29 countries. The first clinical trial for insulin icodec was conducted in 2016 and sponsored by Hamad Medical Corporation. It involved 150 participants and completed its N/A drug approval stage. Since 2016, 452 studies have been conducted."

Answered by AI

Is this the first time insulin icodec has been trialed?

"There are currently 21 ongoing clinical trials evaluating insulin icodec's efficacy. Out of these, 8 are in Phase 3. Most of the research being conducted is taking place in Baltimore, Maryland; however, there are 435 different locations running clinical trials for insulin icodec."

Answered by AI

Do you have any open positions for volunteers right now?

"Recruitment for this clinical trial has ceased. The study was originally posted on April 30th, 2021 and was last updated on October 7th, 2022. If you're looking for similar studies, there are currently 1302 studies for patients with diabetes and 21 studies for patients with autoimmune conditions actively recruiting participants."

Answered by AI

Why is insulin icodec often prescribed?

"liraglutide is often co-administered with insulin icodec. However, insulin icodec can also be used as a monotherapy to treat other conditions like exercise, gestational diabetes mellitus (gdm), and type 1 diabetes mellitus."

Answered by AI

How will insulin icodec impact the safety of individuals?

"Insulin icodec is a Phase 3 trial drug, which means that while there is some efficacy data, there is stronger evidence for its safety. Our team at Power gives it a 3."

Answered by AI

Who else is applying?

What state do they live in?
Texas
California
How old are they?
18 - 65
What portion of applicants met pre-screening criteria?
Met criteria
What site did they apply to?
Novo Nordisk Investigational Site
Recent research and studies
clinicaltrials.govStudy
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)
2021. "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)". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04848480.
~149 spots leftby Apr 2025
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