What side effects are associated with this type of intervention?

Common treatments for Type 2 Diabetes, such as long-acting insulins like Insulin Icodec, can cause side effects including hypoglycemia (low blood sugar), weight gain, and injection site reactions. Oral medications like metformin may cause gastrointestinal issues such as nausea and diarrhea. GLP-1 receptor agonists, another class of diabetes medications, can lead to side effects like nausea, vomiting, and potential risk of pancreatitis. It is important to discuss these potential side effects with a healthcare provider to manage and mitigate risks effectively.

What prior FDA approvals exist?

The FDA has approved several long-acting insulins for the treatment of Type 2 Diabetes, which provide a steady release of insulin to help control blood sugar levels. Notable examples include insulin glargine (Lantus), insulin detemir (Levemir), and insulin degludec (Tresiba). These insulins are designed to be administered once daily to maintain consistent blood glucose levels. Additionally, the FDA has approved GLP-1 receptor agonists like dulaglutide (Trulicity), which are also administered once weekly and help improve glycemic control by enhancing insulin secretion and inhibiting glucagon release.

What other types of research exist?

Promising alternatives to Insulin Icodec for Type 2 Diabetes patients include Insulin Degludec, an ultra-long-acting insulin with a duration of action over 42 hours, and extended-release exenatide, a GLP-1 receptor agonist approved for once-weekly administration. Both have shown good efficacy and safety profiles in clinical trials.

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Insulin

Once-Weekly Insulin Icodec for Type 2 Diabetes (ONWARDS 9 Trial)

Q: What is the mechanism of action of this treatment?

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.

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 below

Select...

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)

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

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

0 / 4Eligibility criteria met

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.