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Insulin

Long-acting Insulin Icodec for Type 2 Diabetes in Youth If there was an error and this study is actually intended for adults (18+), then the title would simply be: Long-acting Insulin Icodec for Type 2 Diabetes

Phase 1
Recruiting
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
Male or female aged 10 to less than 18 years at the time of signing informed consent
Treated with basal insulin, premix insulin or continuous subcutaneous insulin infusion (CSII) with or without bolus insulin or additional anti-diabetic drug(s)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up from 0 hours until last measurement time after trial product administration (day 1)
Awards & highlights

Study Summary

This trial is testing a new medicine for diabetes, which will be injected with a needle into a skin fold in the afternoon/evening. Participants must be 18+ and not pregnant/nursing.

Who is the study for?
This trial is for children and teenagers aged 10 to less than 18 with type 2 diabetes, currently on daily insulin treatment. They must have stable insulin doses for at least the past month and an HbA1c level of ≤10%. Participants should not be pregnant, breastfeeding, planning pregnancy, or have serious health conditions.Check my eligibility
What is being tested?
The study tests a new long-acting insulin called Insulin Icodec in young people with type 2 diabetes. It involves one dose administered subcutaneously using a pen injector. The trial will monitor how this new insulin works over approximately eight weeks.See study design
What are the potential side effects?
While specific side effects are not listed here, common side effects of insulin therapy can include low blood sugar (hypoglycemia), injection site reactions, weight gain, and possibly allergic reactions.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am between 10 and 17 years old.
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I am currently being treated with insulin or other diabetes medications.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from 0 hours until infinity after trial product administration (day 1)
This trial's timeline: 3 weeks for screening, Varies for treatment, and from 0 hours until infinity after trial product administration (day 1) for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Area under the serum insulin icodec concentration-time curve after a single dose (AUCIco,0-inf,SD)
Maximum observed serum insulin icodec concentration after a single dose (Cmax,Ico,SD)
Time to maximum observed serum insulin icodec concentration after a single dose (tmax,Ico,SD)
Secondary outcome measures
Model-based area under the serum insulin icodec concentration-time curve during one dosing interval at steady state (AUC,Ico,τ,SS,model)
Model-based maximum serum insulin icodec concentration during one dosing interval at steady state (Cmax,Ico,SS,model)

Side effects data

From 2020 Phase 2 trial • 247 Patients • NCT03751657
11%
Headache
8%
Nasopharyngitis
6%
Upper respiratory tract infection
1%
Lower limb fracture
1%
Metrorrhagia
100%
80%
60%
40%
20%
0%
Study treatment Arm
Insulin 287
Insulin Glargine

Trial Design

1Treatment groups
Experimental Treatment
Group I: Participants with Type 2 DiabetesExperimental Treatment1 Intervention
Participants will receive single subcutaneous (s.c.) fixed dose of insulin icodec (700 units per milliliter [U/mL]) that is 5.6 units per kilogram (U/kg) bodyweight. Subjects will be followed up for 5 weeks after dosing.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Insulin icodec
2021
Completed Phase 3
~4120

Find a Location

Who is running the clinical trial?

Novo Nordisk A/SLead Sponsor
1,514 Previous Clinical Trials
2,415,049 Total Patients Enrolled
Clinical Transparency dept. 2834Study DirectorNovo Nordisk A/S
36 Previous Clinical Trials
522,988 Total Patients Enrolled

Media Library

Insulin Icodec (Insulin) Clinical Trial Eligibility Overview. Trial Name: NCT05790681 — Phase 1
Type 2 Diabetes Research Study Groups: Participants with Type 2 Diabetes
Type 2 Diabetes Clinical Trial 2023: Insulin Icodec Highlights & Side Effects. Trial Name: NCT05790681 — Phase 1
Insulin Icodec (Insulin) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05790681 — Phase 1
Type 2 Diabetes Patient Testimony for trial: Trial Name: NCT05790681 — Phase 1

Frequently Asked Questions

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

Are individuals aged 55 and above eligible to participate in this research trial?

"Affording the opportunity to participate in this study are those aged 10 and above, but younger than 18."

Answered by AI

Has the FDA authorized participants with Type 2 Diabetes to take part in this study?

"Due to limited evidence of safety and efficacy, participants with Type 2 diabetes are assigned a score of 1 in terms of potential risks when participating in this Phase 1 trial."

Answered by AI

Who should be considered as ideal participants for this trial?

"To gain admittance to this study, participants must possess a diagnosis of type 2 diabetes and be within the age range of 10-18 years. As such, approximately 16 patients will be accepted into the trial."

Answered by AI

Are there any current opportunities for individuals to join this research endeavor?

"As reported on clinicaltrials.gov, this research is not accepting new participants at the moment. This inquiry was first posted on March 20th 2023 and has since been updated twice; the last update being conducted on March 17th 2023. Although recruitment for this trial has ceased, there are currently 802 other medical studies recruiting patients."

Answered by AI

Are there any US-based sites executing this experiment?

"This study is accepting participants at 11 different sites, with major hubs in New Haven, Jacksonville and Baton Rouge. Those wishing to participate should consider the site closest to them so that they can limit their travel needs if accepted."

Answered by AI

Who else is applying?

What state do they live in?
Connecticut
California
What site did they apply to?
Novo Nordisk Investigational Site
What portion of applicants met pre-screening criteria?
Did not meet criteria
How many prior treatments have patients received?
0

Why did patients apply to this trial?

I'm trying to find help with my diabetes.
PatientReceived no prior treatments
Recent research and studies
clinicaltrials.govStudy
A Study to Test How New Long-acting Insulin (Insulin Icodec) Works in the Body of Children and Teenagers
2023. "A Study to Test How New Long-acting Insulin (Insulin Icodec) Works in the Body of Children and Teenagers". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05790681.
~10 spots leftby Jan 2026
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