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Insulin

Insulin icodec for Type 2 Diabetes (ONWARDS 1 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
Insulin naïve. However, short term insulin treatment for a maximum of 14 days prior to the day of screening is allowed, as is prior insulin treatment for gestational diabetes.
Stable daily dose(s) 90 days or more prior to the day of screening of any of the following anti-diabetic drug(s) or combination regimen(s): a. Any metformin formulations at least or greater than 1500 mg or maximum tolerated or effective dose. b. Any metformin combination formulations equal to or above 1500 mg or maximum tolerated or effective dose. c. Any of the following oral anti-diabetic drug classes including combinations ((equal to or above half of the maximum approved dose according to local label or maximum tolerated or effective dose): Sulfonylureas, Meglitinides (glinides), dipeptidyl peptidase-4 (DPP-4) inhibitors, Sodium-glucose co-transporter-2 (SGLT2) inhibitors, Thiazolidinediones, Alpha-glucosidase inhibitors, Oral combination products (for the allowed individual oral anti-diabetic drugs), Oral or injectable glucagon-like peptide 1 (GLP-1) receptor agonists
Timeline
Screening 3 weeks
Treatment Varies
Follow Up from week 50 (v44) to week 52 (v46)
Awards & highlights

ONWARDS 1 Trial Summary

This trial compares a new weekly insulin to a daily insulin that is already on the market, in people with type 2 diabetes. It will look at how well the weekly insulin controls blood sugar compared to the daily insulin. The study will last for about 1 ½ years, with 37 clinic visits and 26 phone calls with the study doctor.

Eligible Conditions
  • Type 2 Diabetes

ONWARDS 1 Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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Women who have never been treated with insulin can participate in the study, but they must have stopped using insulin for at most 14 days before the screening date
Select...
People with BMI equal to or below 40.0 kg/m^2 are considered to have a very high body weight.

ONWARDS 1 Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from week 50 (v44) to week 52 (v46)
This trial's timeline: 3 weeks for screening, Varies for treatment, and from week 50 (v44) to week 52 (v46) 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 HbA1c
Secondary outcome measures
Change in body weight
Change in fasting plasma glucose (FPG)
Mean weekly insulin dose
+6 more

Side effects data

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

ONWARDS 1 Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Insulin icodecExperimental Treatment1 Intervention
Insulin icodec + non-insulin anti-diabetic drugs. The pre-trial non-insulin anti-diabetic background medication should be maintained at the stable, pre-trial dose and at the same frequency during the entire treatment period
Group II: Insulin glargineActive Control1 Intervention
Insulin glargine + non-insulin anti-diabetic drugs. The pre-trial non-insulin anti-diabetic background medication should be maintained at the stable, pre-trial dose and at the same frequency during the entire treatment period
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
1,503 Previous Clinical Trials
2,384,830 Total Patients Enrolled
Clinical Transparency (1452)Study DirectorNovo Nordisk A/S
7 Previous Clinical Trials
602,043 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 Insulin icodec deadly if used incorrectly?

"Insulin icodec has been studied enough to support its efficacy and safety, and has thus been given a score of 3."

Answered by AI

Is this trial commonly conducted in American hospitals?

"Currently, there are 55 sites worldwide where patients can enroll in this clinical trial. Kenosha, Fresno, Ventura and other cities have active locations where people can be enrolled. To limit travel, it is best to choose the location nearest to you."

Answered by AI

Are there similar treatments to Insulin icodec that have been tested in the past?

"Insulin icodec was first trialled in 2005 by the Division of Paediatrics at Karolinska University Hospital. Since then, there have been 398 completed studies. There are 17 active studies currently underway, with a large concentration of these in Kenosha, Wisconsin."

Answered by AI

How many people are you testing this medication on?

"Unfortunately, this study is no longer enrolling patients. The posting for this clinical trial was first published on November 25th, 2020 and was last updated on November 3rd, 2022. However, there are 1,453 other trials related to diabetes mellitus, type 2 currently enrolling patients and 17 trials for Insulin icodec that are still admitting participants."

Answered by AI

What medical conditions are most often remedied by Insulin icodec?

"Insulin icodec is most commonly used as a form of diet control, but it also has benefits for patients with type 1 diabetes mellitus, type 2 diabetes mellitus, and hyperglycemia."

Answered by AI

Who else is applying?

What state do they live in?
Texas
How old are they?
18 - 65
What site did they apply to?
Novo Nordisk Investigational Site
What portion of applicants met pre-screening criteria?
Met criteria
~227 spots leftby Mar 2025