What is the mechanism of action of this treatment?

Common treatments for Type 2 Diabetes, such as insulin and GLP-1 receptor agonists, work through complementary mechanisms to manage blood glucose levels. Insulin icodec, a long-acting insulin, facilitates cellular glucose uptake, thereby reducing blood glucose levels. Semaglutide, a GLP-1 receptor agonist, enhances insulin secretion in response to food intake, inhibits glucagon release, and slows gastric emptying. These actions help to improve blood glucose control by addressing both insulin deficiency and insulin resistance, which are central to the management of Type 2 Diabetes.

What side effects are associated with this type of intervention?

Common treatments for Type 2 Diabetes, such as insulin icodec and GLP-1 receptor agonists like semaglutide, have specific side effects. Insulin icodec can cause hypoglycemia, weight gain, and injection site reactions. Semaglutide may lead to gastrointestinal issues like nausea, vomiting, and diarrhea, and there are concerns about potential risks of pancreatitis and rare cases of pancreatic cancer. Both treatments require careful monitoring to manage these side effects effectively.

What prior FDA approvals exist?

The FDA has approved several long-acting insulins and GLP-1 receptor agonists for the treatment of Type 2 Diabetes. Long-acting insulins such as insulin glargine and insulin degludec help lower blood glucose by facilitating cellular glucose uptake. GLP-1 receptor agonists like semaglutide, liraglutide, and exenatide enhance insulin secretion and inhibit glucagon release. Combination therapies, such as those involving insulin and GLP-1 receptor agonists, have been explored to improve glycemic control by leveraging the complementary mechanisms of these drugs.

What other types of research exist?

Promising alternatives to IcoSema for Type 2 Diabetes patients include: 1) Tirzepatide, a dual GIP and GLP-1 receptor agonist, which has shown significant efficacy in glycemic control and weight loss. 2) Oral semaglutide, which offers the convenience of oral administration while providing similar benefits to injectable GLP-1 receptor agonists. 3) Weekly insulin glargine combined with GLP-1 receptor agonists, which may offer similar benefits to IcoSema with a different insulin component.

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Combination Product

IcoSema for Type 2 Diabetes (COMBINE 1 Trial)

Verified 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

Are you 18 years or older?

Is your HbA1c between 7% and 10%?

Timeline

Screening 3 days

Treatment Varies

Follow Up 3 days

Awards & highlights

No Placebo-Only Group

Pivotal Trial

Summary

This trial will test a new weekly injection called IcoSema, which combines two drugs, in people with type 2 diabetes. The goal is to see if it controls blood sugar better than just using one of the drugs alone. Participants will receive either IcoSema or the single drug and will be monitored for several months.

Who is the study for?

This trial is for adults with type 2 diabetes who have been managing their condition for at least 6 months and have an HbA1c level between 7% and 10%. They should be using insulin once or twice daily. Pregnant or breastfeeding women, or those planning to become pregnant during the study, cannot participate.

What is being tested?

The trial is testing IcoSema—a new weekly medication combining insulin icodec and semaglutide—against weekly insulin icodec alone. The goal is to see which one controls blood sugar better in people with type 2 diabetes over approximately a year of treatment involving injections with a pen device.

What are the potential side effects?

Potential side effects may include typical reactions to insulin such as low blood sugar levels, injection site reactions, weight gain, tiredness, allergic reactions including skin rash or itching. Semaglutide can cause nausea, vomiting, diarrhea, abdominal pain and loss of appetite.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am 18 years old or older.

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Your average blood sugar level, as measured by HbA1c, should be between 7% and 10%.

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I have had type 2 diabetes for at least 6 months.

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I use insulin once or twice daily.

Timeline

Screening ~ 3 days1 visit

Treatment ~ Varies

Follow Up ~ 3 days1 visit

Screening ~ 3 days

Treatment ~ Varies

Follow Up ~3 days

This trial's timeline: 3 days for screening, Varies for treatment, and 3 days 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 body weight

Number of clinically significant hypoglycaemic episodes (level 2) (below 3.0 mmol/L (54 mg/dL), confirmed by BG meter) or severe hypoglycaemic episodes (level 3)

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

Active Control

Group I: IcoSemaExperimental Treatment1 Intervention

Group II: Insulin icodecActive Control1 Intervention

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

IcoSema

2021

Completed Phase 3

~1990

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, such as insulin and GLP-1 receptor agonists, work through complementary mechanisms to manage blood glucose levels. Insulin icodec, a long-acting insulin, facilitates cellular glucose uptake, thereby reducing blood glucose levels. Semaglutide, a GLP-1 receptor agonist, enhances insulin secretion in response to food intake, inhibits glucagon release, and slows gastric emptying. These actions help to improve blood glucose control by addressing both insulin deficiency and insulin resistance, which are central to the management of Type 2 Diabetes.