What side effects are associated with this type of intervention?

Common treatments for Type 2 Diabetes, such as insulin and GLP-1 receptor agonists, have specific side effects. Insulin treatments can cause hypoglycemia, weight gain, and injection site reactions. GLP-1 receptor agonists, like semaglutide, often cause gastrointestinal issues such as nausea, vomiting, and diarrhea, and may also lead to weight loss and, rarely, pancreatitis. Combining these treatments, as in IcoSema, may result in a combination of these side effects.

What prior FDA approvals exist?

The FDA has approved several treatments for Type 2 Diabetes that are similar to the components of IcoSema. Insulin analogs like insulin glargine and insulin detemir have been approved to help regulate blood sugar by facilitating glucose uptake into cells. GLP-1 receptor agonists such as liraglutide, exenatide, dulaglutide, and semaglutide have also been approved. These drugs increase insulin secretion and decrease glucagon release in response to meals. Combination therapies, such as those involving insulin and GLP-1 receptor agonists, have been explored to improve glycemic control in patients with Type 2 Diabetes.

What other types of research exist?

Promising novel alternatives to IcoSema for Type 2 Diabetes patients include: 1) Tirzepatide, a dual GIP and GLP-1 receptor agonist, which has shown 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. Both alternatives have demonstrated significant improvements in glycemic control and weight management in clinical trials.

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Combination Drug

IcoSema for Type 2 Diabetes (COMBINE 2 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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up from baseline week 0 (v2) to week 57 (v56)

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 the existing drug, semaglutide. Participants will be randomly assigned to receive either IcoSema or semaglutide for several months.

Who is the study for?

Adults with type 2 diabetes, BMI ≤40.0 kg/m^2, stable on certain diabetes meds for 90+ days, and HbA1c between 7.0-10.0%. Excludes those with recent severe heart failure or pancreatitis, uncontrolled diabetic eye disease, recent major cardiovascular events, pregnant/breastfeeding women or those planning pregnancy without effective contraception.

What is being tested?

The trial is testing IcoSema—a new weekly injectable combo of insulin icodec and semaglutide—against the existing diabetes medication semaglutide alone. Participants will be randomly assigned to one of these treatments for about a year and monitored through clinic visits and calls.

What are the potential side effects?

Potential side effects may include typical reactions at injection sites (like pain or swelling), low blood sugar levels (hypoglycemia), nausea, digestive issues due to insulin or GLP-1 receptor agonists in the medications being tested.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ from baseline week 0 (v2) to week 57 (v56)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~from baseline week 0 (v2) to week 57 (v56)

This trial's timeline: 3 weeks for screening, Varies for treatment, and from baseline week 0 (v2) to week 57 (v56) 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

Change in fasting plasma glucose (FPG)

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

+2 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: SemaglutideExperimental Treatment1 Intervention

Participants will get once weekly dose

Group II: IcoSemaExperimental Treatment1 Intervention

Participants will get once weekly dose

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

IcoSema

2021

Completed Phase 3

~1990

Do I qualify?Apply below to find out

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 insulin therapy and GLP-1 receptor agonists. Insulin, such as insulin icodec, helps regulate blood sugar by facilitating glucose uptake into cells, thereby lowering blood glucose levels. GLP-1 receptor agonists, like semaglutide, increase insulin secretion and decrease glucagon release in response to meals, aiding in blood sugar control. These treatments are essential for Type 2 Diabetes patients as they address insulin resistance and impaired insulin secretion, helping to maintain better glycemic control and reduce the risk of complications.