← Back to Search

Insulin

Once-Weekly Insulin Icodec for Type 2 Diabetes (ONWARDS 9 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
Age above or equal to 18 years at the time of signing informed consent
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up from initiation week 0 (visit 3) to week 26 (visit 26)
Awards & highlights

ONWARDS 9 Trial Summary

This trial will test how well a weekly insulin injection and a small sensor inserted under the skin can control blood sugar in people with type 2 diabetes. Participants will have to wear the sensor and inject insulin for 8 months.

Who is the study for?
This trial is for adults over 18 with type 2 diabetes who haven't used insulin before. They should have an HbA1c level between 7.0%-11.0% and a BMI of <=40 kg/m^2, be on stable diabetes medication doses, and not planning to change medications that affect weight or glucose metabolism during the study.Check my eligibility
What is being tested?
The trial tests Insulin Icodec, a new once-weekly injectable insulin combined with continuous blood sugar monitoring using a flash glucose sensor. Participants will use this treatment for about 8 months while regularly scanning their glucose levels with a provided phone.See study design
What are the potential side effects?
Potential side effects may include typical insulin-related reactions like low blood sugar (hypoglycemia), injection site reactions, allergic responses, weight changes, and possibly others as it's a new form of insulin.

ONWARDS 9 Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I am 18 years old or older.

ONWARDS 9 Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from initiation week 0 (visit 3) to week 26 (visit 26)
This trial's timeline: 3 weeks for screening, Varies for treatment, and from initiation week 0 (visit 3) to week 26 (visit 26) 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 glycated haemoglobin (HbA1c)

Side effects data

From 2016 Phase 4 trial • 85 Patients • NCT01970241
21%
Hypoglycemia
100%
80%
60%
40%
20%
0%
Study treatment Arm
NPH With Corticosteroid
Control

ONWARDS 9 Trial Design

1Treatment groups
Experimental Treatment
Group I: Insulin IcodecExperimental Treatment1 Intervention
Participants will receive 70 Units (U) insulin icodec subcutaneously once-weekly for 26 weeks.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Insulin Icodec
2021
Completed Phase 3
~630

Find a Location

Who is running the clinical trial?

Novo Nordisk A/SLead Sponsor
1,518 Previous Clinical Trials
2,415,879 Total Patients Enrolled
Clinical Transparency (dept. 2834)Study DirectorNovo Nordisk A/S
109 Previous Clinical Trials
140,461 Total Patients Enrolled

Media Library

Insulin Icodec (Insulin) Clinical Trial Eligibility Overview. Trial Name: NCT05823948 — Phase 3
Type 2 Diabetes Research Study Groups: Insulin Icodec
Type 2 Diabetes Clinical Trial 2023: Insulin Icodec Highlights & Side Effects. Trial Name: NCT05823948 — Phase 3
Insulin Icodec (Insulin) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05823948 — Phase 3

Frequently Asked Questions

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

Has the FDA endorsed Insulin Icodec?

"There is a history of clinical data that supports the safety profile of Insulin Icodec, which has earned it a score of 3."

Answered by AI

Which areas are offering access to this research protocol?

"Currently, nine different sites are running this trial. Choosing a centre close to you is encouraged as it helps reduce the need for travel; these locations include Sacramento, Minneapolis and Las Vegas in addition to six other cities."

Answered by AI

Are there still openings in this research study for participants?

"As indicated on clinicaltrials.gov, the posting for this study is no longer accepting patients. It was initially published on April 11th 2023 and most recently edited on April 9th 2023. However, there are numerous other trials that require participants; at current count 1423 studies have open recruitment."

Answered by AI

Who else is applying?

What state do they live in?
Minnesota
What site did they apply to?
Novo Nordisk Investigational Site
What portion of applicants met pre-screening criteria?
Met criteria
Did not meet criteria
How many prior treatments have patients received?
2

Why did patients apply to this trial?

I enjoy trying new things. I've tried many drugs for type 2 diabetes that have not worked Hopefully this will work.
PatientReceived 2+ prior treatments
I am having trouble controlling the high blood sugar levels so thought a weekly dose might give me less highs.
PatientReceived no prior treatments
Recent research and studies
clinicaltrials.govStudy
A Study Using Flash Glucose Measurements for a New Once-weekly Insulin (Insulin Icodec) in People With Type 2 Diabetes Who Have Not Used Insulin Before (ONWARDS 9)
2023. "A Study Using Flash Glucose Measurements for a New Once-weekly Insulin (Insulin Icodec) in People With Type 2 Diabetes Who Have Not Used Insulin Before (ONWARDS 9)". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05823948.
~24 spots leftby May 2025
Unbiased ResultsWe believe in providing patients with all the options.
Your Data Stays Your DataWe only share your information with the clinical trials you're trying to access.
Verified Trials OnlyAll of our trials are run by licensed doctors, researchers, and healthcare companies.
Back to top