IcoSema for Type 2 Diabetes

(COMBINE 4 Trial)

Recruiting at 111 trial locations

Overseen By Novo Nordisk

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 3

Waitlist Available

Sponsor: Novo Nordisk A/S

No Placebo Group

Pivotal Trial (Near Approval)

Prior Safety Data

Trial Summary

What is the purpose of this trial?

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.

Research Team

Clinical Transparency (dept. 2834)

Principal Investigator

Novo Nordisk A/S

Eligibility Criteria

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.

Inclusion Criteria

I am 18 years or older.

I've been taking 1-3 diabetes pills daily for at least 90 days.

HbA1c ≥ 8.0% (≥ 64.0 millimoles per mole [mmol/mol]) as assessed by central laboratory on the day of screening

Exclusion Criteria

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

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

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

Treatment Details

Interventions

• IcoSema (Combination Therapy)
• Insulin glargine (Hormone Therapy)

Trial Overview 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.

Participant Groups

Group I: Insulin glargine Experimental Treatment 1 Intervention

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

Group II: IcoSema Experimental Treatment 1 Intervention

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

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