IcoSema for Type 2 Diabetes

Recruiting at 245 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

679 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial will test a new weekly injection called IcoSema, which combines two drugs, in people with type 2 diabetes. It aims to see if IcoSema can control blood sugar better than the current daily treatments. Participants will receive either IcoSema or the standard daily injections. The study will take place over several months, and participants will wear a sensor to monitor their blood sugar levels.

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