IcoSema for Type 2 Diabetes
(COMBINE 2 Trial)

Recruiting in Palo Alto (17 mi)

+265 other locations

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 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.

Eligibility Criteria

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.

Inclusion Criteria

You have been diagnosed with type 2 diabetes for at least 180 days before the screening.

Your HbA1c level is between 7.0% and 10.0% as tested by the central laboratory at the time of screening.

Male or female and age above or equal to 18 years at the time of signing informed consent

+9 more

Exclusion Criteria

You have severe chronic heart failure.

Female who is pregnant, breast-feeding or intends to become pregnant or is of childbearing potential and not using a highly effective contraceptive method

Anticipated initiation or change in concomitant medication (for more than 14 consecutive days) known to affect weight or glucose metabolism

+5 more

Participant Groups

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.

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