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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
Must not have
Chronic heart failure classified as being in New York Heart Association (NYHA) Class IV at screening
Myocardial infarction, stroke, transient ischaemic attack or hospitalisation for unstable angina pectoris within 180 days before the day of screening and between screening and initiation visits
Timeline
Screening 3 weeks
Treatment Varies
Follow Up from initiation week 0 (visit 3) to week 26 (visit 26)
Awards & highlights
No Placebo-Only Group
Pivotal Trial
Summary
This trial tests a new insulin injection and a small device that continuously measures blood sugar levels for people with type 2 diabetes. The goal is to see how well this combination controls blood sugar. Participants will use an app to share their blood sugar data with the study team.
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.
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.
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.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am 18 years old or older.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I have severe heart failure that severely limits my daily activities.
Select...
I haven't had a heart attack, stroke, or severe chest pain in the last 6 months.
Select...
I haven't had diabetic ketoacidosis in the last 90 days.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ from initiation week 0 (visit 3) to week 26 (visit 26)
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from initiation week 0 (visit 3) to week 26 (visit 26)
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Change in glycated haemoglobin (HbA1c)
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
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
Research Highlights
Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.Mechanism Of Action
Side Effect Profile
Prior Approvals
Other Research
Common treatments for Type 2 Diabetes include long-acting insulins, GLP-1 receptor agonists, and oral hypoglycemic agents. Long-acting insulins, such as Insulin Icodec, provide a steady release of insulin over an extended period (e.g., a week), helping to maintain stable blood glucose levels and reduce the risk of hyperglycemia.
GLP-1 receptor agonists enhance insulin secretion in response to meals and slow gastric emptying, which helps to control postprandial blood sugar spikes. Oral hypoglycemic agents, like metformin, decrease hepatic glucose production and improve insulin sensitivity.
These mechanisms are crucial for Type 2 Diabetes patients as they help to manage blood sugar levels effectively, reduce complications, and improve overall quality of life.
The use of continuous glucose monitoring in patients with type 2 diabetes.Oral spray insulin in treatment of type 2 diabetes: a comparison of efficacy of the oral spray insulin (Oralin) with subcutaneous (SC) insulin injection, a proof of concept study.Optimized transient insulin infusion in uncontrolled type 2 diabetes: evaluation of a pragmatic attitude.
The use of continuous glucose monitoring in patients with type 2 diabetes.Oral spray insulin in treatment of type 2 diabetes: a comparison of efficacy of the oral spray insulin (Oralin) with subcutaneous (SC) insulin injection, a proof of concept study.Optimized transient insulin infusion in uncontrolled type 2 diabetes: evaluation of a pragmatic attitude.
Find a Location
Who is running the clinical trial?
Novo Nordisk A/SLead Sponsor
1,551 Previous Clinical Trials
2,444,854 Total Patients Enrolled
Clinical Transparency (dept. 2834)Study DirectorNovo Nordisk A/S
131 Previous Clinical Trials
153,095 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have not used insulin regularly, except for a short period or during pregnancy.Your body mass index (BMI) is 40 or lower.I am taking diabetes medication at a significant dose.I have been on a stable dose of my diabetes medication for at least 90 days.I have severe heart failure that severely limits my daily activities.Your HbA1c levels are between 7.0% and 11.0%.I plan to start or change medication soon that could affect my weight or blood sugar.I was diagnosed with type 2 diabetes more than 6 months ago.I haven't had a heart attack, stroke, or severe chest pain in the last 6 months.I don't have unstable diabetic eye problems verified by a recent eye exam.I am 18 years old or older.I need insulin to control my morning blood sugar levels.I haven't had diabetic ketoacidosis in the last 90 days.
Research Study Groups:
This trial has the following groups:- Group 1: Insulin Icodec
Awards:
This trial has 2 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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