What side effects are associated with this type of intervention?

Long-acting insulin analogs, such as insulin glargine, are commonly associated with side effects like hypoglycemia (low blood sugar), weight gain, and injection site reactions. GLP-1 receptor agonists, such as semaglutide, often cause gastrointestinal issues including nausea, vomiting, and diarrhea. They may also lead to weight loss and have been linked to a potential risk of pancreatitis and, in rare cases, thyroid tumors.

What prior FDA approvals exist?

The FDA has approved several treatments for Type 2 Diabetes that are similar to the components of IcoSema. Insulin glargine, a long-acting insulin analog, is widely prescribed and has been approved for managing blood sugar levels. Semaglutide, a GLP-1 receptor agonist, has also received FDA approval for its efficacy in improving glycemic control and promoting weight loss. Other GLP-1 receptor agonists like liraglutide and extended-release exenatide have been approved for both adults and children with Type 2 Diabetes. These approvals highlight the effectiveness of combining long-acting insulin analogs and GLP-1 receptor agonists in diabetes management.

What other types of research exist?

Promising novel alternatives to IcoSema for Type 2 Diabetes patients include: 1) Oral Semaglutide, a GLP-1 receptor agonist, which has shown efficacy in various clinical trials (PIONEER studies). 2) Tirzepatide, a dual GIP and GLP-1 receptor agonist, which has demonstrated significant glycemic control and weight loss benefits. 3) Once-weekly Exenatide, another GLP-1 receptor agonist, which has been effective in improving glycemic control. These alternatives offer different administration routes and mechanisms of action that may suit individual patient needs.

← Back to Search

Combination Therapy

IcoSema for Type 2 Diabetes (COMBINE 4 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

Be older than 18 years old

Must not have

History of myocardial infarction, stroke, hospitalization for unstable angina pectoris or transient ischaemic attack within 180 days before screening

Chronic heart failure classified as being in New York Heart Association Class IV at screening

Timeline

Screening 3 weeks

Treatment Varies

Follow Up from week 38 to week 40

Awards & highlights

No Placebo-Only Group

Pivotal Trial

Summary

This trial will compare IcoSema, a new treatment combining two medicines, to insulin glargine in people with type 2 diabetes. The study targets those whose blood sugar isn't controlled by other oral medicines. IcoSema helps the body use sugar more effectively and reduces appetite to manage blood sugar levels. Insulin glargine is a long-acting insulin commonly used with oral antidiabetic drugs to improve blood sugar control in patients with type 2 diabetes.

Who is the study for?

This trial is for people with type 2 diabetes whose blood sugar isn't well-controlled by oral medications. Participants will be randomly chosen to receive either the new weekly medicine IcoSema or daily insulin glargine. The study excludes specific details on eligibility criteria.

What is being tested?

The effectiveness of a new once-weekly medication, IcoSema (a mix of insulin icodec and semaglutide), is being compared to the daily use of insulin glargine in controlling blood sugar levels over approximately 11 months.

What are the potential side effects?

Potential side effects are not detailed here but may include those common to diabetes treatments such as low blood sugar, injection site reactions, weight changes, and gastrointestinal issues.

Eligibility Criteria

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

Select...

I haven't had a heart attack, stroke, or severe heart chest pain in the last 6 months.

Select...

My heart failure is severe, limiting my ability to carry out any physical activity without discomfort.

Select...

I haven't had diabetic ketoacidosis or taken diabetes/obesity meds not listed in the criteria in the last 90 days.

Select...

I have had severe low blood sugar episodes in the last year.

Select...

I have severe, untreated eye problems from diabetes.

Select...

I am pregnant, breastfeeding, planning to become pregnant, or not using effective birth control.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ from week 38 to week 40

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~from week 38 to week 40

This trial's timeline: 3 weeks for screening, Varies for treatment, and from week 38 to week 40 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)

Secondary study objectives

Change in Diabetes Treatment Satisfaction Questionnaire (DTSQs) in total treatment satisfaction

Change in body weight

Change in fasting plasma glucose (FPG)

+7 more

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

2Treatment groups

Experimental Treatment

Group I: Insulin glargineExperimental Treatment1 Intervention

Participants will receive once daily insulin glargine subcutaneously with or without oral anti diabetic drugs for 40 weeks.

Group II: IcoSemaExperimental Treatment1 Intervention

Participants will receive once weekly IcoSema subcutaneously with or without oral anti diabetic drugs for 40 weeks.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Insulin glargine

2013

Completed Phase 4

~10810

IcoSema

2021

Completed Phase 3

~700

0 / 6Eligibility 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

Long-acting insulin analogs, such as insulin icodec, help maintain basal insulin levels to reduce blood glucose levels throughout the day and night, which is crucial for patients with insulin resistance or insufficient insulin production. GLP-1 receptor agonists, like semaglutide, enhance glucose-dependent insulin secretion, suppress glucagon release, slow gastric emptying, and promote satiety. These mechanisms collectively improve glycemic control and aid in weight management, addressing both hyperglycemia and associated metabolic issues in Type 2 Diabetes patients.

Efficacy and Safety of Once-Weekly Semaglutide Versus Exenatide ER in Subjects With Type 2 Diabetes (SUSTAIN 3): A 56-Week, Open-Label, Randomized Clinical Trial.