IcoSema for Type 2 Diabetes

No longer recruiting at 334 trial locations

Overseen By Novo Nordisk

Age: 18+

Sex: Any

Trial Phase: Phase 3

Sponsor: Novo Nordisk A/S

Must be taking: Basal insulin

Must not be taking: Orlistat, Corticosteroids

Disqualifiers: Pregnancy, Pancreatitis, Heart failure, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Pivotal Trial (Near Approval) This treatment is in the last trial phase before FDA approval

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

Duration: 52 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new once-a-week medication called IcoSema for people with type 2 diabetes. It compares IcoSema, a combination of insulin icodec and semaglutide, to a standard daily insulin treatment (insulin glargine with insulin aspart) to determine which better controls blood sugar. Participants will either take IcoSema weekly or the standard insulin treatment daily, assigned randomly. The trial seeks individuals who have had type 2 diabetes for at least six months and currently use a daily insulin treatment. As a Phase 3 trial, this study represents the final step before FDA approval, offering participants a chance to contribute to potentially groundbreaking diabetes treatment.

Will I have to stop taking my current medications?

If you are taking sulfonylureas, meglitinides (glinides), or DPP-4 inhibitors, you will need to stop these medications when you start the trial. Other diabetes medications you are taking can be continued if they have been stable for at least 90 days before the trial.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that IcoSema, a new medicine being tested for type 2 diabetes, has promising safety results. In studies involving over 2,600 patients, IcoSema was generally well-tolerated. About 9% of patients experienced serious side effects, but no deaths were linked to the treatment.

Although these numbers might seem concerning, similar studies often report such rates, and no treatment-related deaths were observed. This suggests that IcoSema could be a safe option for managing diabetes. However, consulting a doctor for personal advice is always recommended. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising for type 2 diabetes?

Researchers are excited about IcoSema for type 2 diabetes because it offers a new approach with a once-weekly injection, while most current treatments require daily doses. This could simplify management for patients and improve adherence to treatment plans. Additionally, IcoSema combines two active ingredients, insulin and semaglutide, which may offer better blood sugar control and weight management compared to standard insulin therapies alone.

What evidence suggests that this trial's treatments could be effective for type 2 diabetes?

Research shows that IcoSema, a mix of insulin icodec and semaglutide, effectively manages type 2 diabetes. In studies with over 2,600 patients, IcoSema significantly improved blood sugar control, demonstrated by a noticeable drop in HbA1c (a measure of long-term blood sugar levels) and fasting blood sugar levels. Participants in that trial experienced reduced concerns about low blood sugar episodes and weight gain. Compared to other insulin treatments, IcoSema provided similar blood sugar control with fewer injections, simplifying the regimen for patients. Overall, evidence suggests that IcoSema could be a promising once-a-week treatment for managing diabetes effectively. Another treatment arm in this trial involves insulin glargine combined with insulin aspart, serving as an active comparator. ^{1 2 3 5 6}

Who Is on the Research Team?

Clinical Transparency (dept. 1452)

Principal Investigator

Novo Nordisk A/S

Are You a Good Fit for This Trial?

Inclusion Criteria

Diagnosed with type 2 diabetes mellitus 180 days or more before screening

HbA1c of 7.0-10.0 percentage (53.- 85.8 mmol/mol) (both inclusive) as assessed by central laboratory on the day of screening

Treated with once daily or twice-daily basal insulin (neutral protamine hagedorn insulin, insulin degludec, insulin detemir, insulin glargine 100 units/mL, or insulin glargine 300 units/mL) 20-80 units/day 90 days or more before screening

Exclusion Criteria

Any of the following: Myocardial infarction, stroke, hospitalization for unstable angina pectoris or transient ischaemic attack within 180 days before screening

Uncontrolled and potentially unstable diabetic retinopathy or maculopathy. Verified by a fundus examination performed within the past 90 days before screening or in the period between screening and randomisation. Pharmacological pupil-dilation is a requirement unless using a digital fundus photography camera specified for non dilated examination.

Any episodes of diabetic ketoacidosis within 90 days before screening. As declared by the participant or in the medical records

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either IcoSema once weekly or insulin glargine daily with insulin aspart for 52 weeks

52 weeks

Weekly injections for IcoSema, daily injections for insulin glargine and insulin aspart

Monitoring

Participants wear a continuous glucose monitoring sensor for 8 weeks at the beginning and 4 weeks at the end of the study

12 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• IcoSema
• Insulin aspart
• Insulin glargine

How Is the Trial Designed?

Group I: IcoSema Experimental Treatment 1 Intervention

Participants will receive once weekly subcutaneous (s.c) injections of IcoSema during the 52-week treatment period.

Group II: Insuling glargine/insulin aspart Active Control 2 Interventions

Participants will receive subcutaneous (s.c) injections of insulin glargine once daily combined with 2-4 times daily injections of insulin aspart.

Who Is Running the Clinical Trial?

Novo Nordisk A/S

Lead Sponsor

Trials

1,578

Recruited

3,813,000+

Lars Fruergaard Jørgensen

Novo Nordisk A/S

Chief Executive Officer since 2017

MSc in Finance and Business Administration, Aarhus School of Business, Aarhus University, Denmark

Martin Holst Lange

Novo Nordisk A/S

Chief Medical Officer since 2021

MD from University of Copenhagen

Citations

1. endocrinologydiabetes.org endocrinologydiabetes.org/article/S3050-9157(25)00070-0/fulltext

Efficacy and Safety of Once-Weekly IcoSema in Adults With ... IcoSema, evaluated in 3 low-bias randomized controlled trials (RCTs) with 2653 patients with type 2 diabetes, significantly improved HbA1c ...

2. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/39820580/

the COMBINE 2 randomised clinical trial The estimated mean change in fasting plasma glucose from baseline to week 52 was statistically significantly reduced with IcoSema vs semaglutide (-2.48 mmol/l ...

3. sciencedirect.com sciencedirect.com/science/article/abs/pii/S2213858725000968

Once‑weekly IcoSema versus once‑weekly insulin icodec ... Overall, IcoSema might provide an option for insulin therapy intensification in adults with type 2 diabetes, reducing concerns around hypoglycaemia and weight ...

4. sciencehub.novonordisk.com sciencehub.novonordisk.com/content/dam/sciencehub/global/en/congresses-and-scientific-publications/congresses/easd2025/ji/documents/EASD25_Pre-trial_SGLT2i_ShortOral_12Sep25_Final.pdf

Efficacy and hypoglycaemia outcomes with once-weekly IcoSema vs comparators in type 2 diabetes according to pre-trial sodium-glucose cotransporter-2 inhibitor use: a post hoc ...

5. thelancet.com thelancet.com/journals/landia/article/PIIS2213-8587(25)00052-X/abstract

Once-weekly IcoSema versus multiple daily insulin ... Once-weekly IcoSema achieved non-inferior HbA1c reduction and superiority in change in bodyweight, weekly total insulin dose, and hypoglycaemia ...

6. clinicaltrials.gov clinicaltrials.gov/study/NCT05259033

NCT05259033 | A Research Study to See How Well the ... The study will look at how well IcoSema controls blood sugar level in people with type 2 diabetes compared to semaglutide. Participants will either get IcoSema ...