IcoSema for Type 2 Diabetes

(COMBINE 4 Trial)

Recruiting at 113 trial locations

Overseen By Novo Nordisk

Age: 18+

Sex: Any

Trial Phase: Phase 3

Sponsor: Novo Nordisk A/S

Must be taking: Oral antidiabetics

Must not be taking: Corticosteroids, Orlistat, others

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: 40 weeks

485 Participants Needed

What You Need to Know Before You Apply

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.

Do I need to stop my current medications to join the trial?

The trial does not specify if you need to stop your current medications. However, you must be on stable doses of 1-3 oral diabetes medications for at least 90 days before joining the trial.

How is the drug IcoSema different from other treatments for type 2 diabetes?

IcoSema is unique because it combines insulin glargine, a long-acting insulin that provides stable blood sugar control over 24 hours, with another component that may enhance its effectiveness. This combination could offer more consistent blood sugar management compared to other treatments that require multiple daily injections. ^{1 2 3 4 5}

What data supports the effectiveness of the drug IcoSema for Type 2 Diabetes?

Research shows that insulin glargine, a component of IcoSema, is effective in controlling blood sugar levels in people with Type 2 Diabetes. It provides stable blood sugar control over 24 hours and reduces the risk of low blood sugar, especially at night. ^{1 2 3 6 7}

Who Is on the Research Team?

Clinical Transparency (dept. 2834)

Principal Investigator

Novo Nordisk A/S

Are You a Good Fit for This Trial?

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'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

Body mass index (BMI) less than or equal to 40.0 kilogram per square meter (kg/m^2)

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.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either once weekly IcoSema or daily insulin glargine for 40 weeks

40 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

7 weeks

What Are the Treatments Tested in This Trial?

Interventions

• IcoSema
• Insulin glargine

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.

How Is the Trial Designed?

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

Published Research Related to This Trial

In a study involving 1,291 patients with type 1 and type 2 diabetes, LY2963016 insulin glargine (LY IGlar) showed similar immunogenicity profiles to Lantus® insulin glargine (IGlar), with low levels of anti-insulin glargine antibodies observed in both groups.

There were no significant differences in clinical outcomes or safety between LY IGlar and IGlar, indicating that both treatments are equally effective and safe for managing diabetes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Evaluation of immunogenicity of LY2963016 insulin glargine compared with Lantus® insulin glargine in patients with type 1 or type 2 diabetes mellitus. Ilag, LL., Deeg, MA., Costigan, T., et al.[2018]

In a pilot study involving 52 patients with Type 2 diabetes poorly controlled on premixed insulin, switching to insulin glargine combined with oral antidiabetic drugs (OADs) significantly improved glycaemic control, as evidenced by a notable decrease in HbA1c levels in both treatment groups (A and B).

The study found no significant differences in hypoglycaemia rates between the treatment groups, indicating that insulin glargine plus OADs is a safe alternative to premixed insulin therapy, with high patient satisfaction leading to a majority opting to continue their assigned treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy and treatment satisfaction of once-daily insulin glargine plus one or two oral antidiabetic agents versus continuing premixed human insulin in patients with type 2 diabetes previously on long-term conventional insulin therapy: the Switch pilot study. Schiel, R., Müller, UA.[2022]

In a pilot study of 52 patients with Type 2 diabetes, switching from premixed insulin to insulin glargine combined with oral antidiabetic drugs (OADs) led to significant reductions in HbA1c levels, indicating improved glycaemic control.

The study found no significant differences in hypoglycaemia rates between the treatment groups, suggesting that insulin glargine plus OADs is a safe alternative to premixed insulin for patients with inadequate glycaemic control.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy and treatment satisfaction of once-daily insulin glargine plus one or two oral antidiabetic agents versus continuing premixed human insulin in patients with Type 2 diabetes previously on long-term conventional insulin therapy: the SWITCH Pilot Study. Schiel, R., Müller, UA.[2022]

Citations

1. England pubmed.ncbi.nlm.nih.gov

Evaluation of immunogenicity of LY2963016 insulin glargine compared with Lantus® insulin glargine in patients with type 1 or type 2 diabetes mellitus. [2018]

2. United States pubmed.ncbi.nlm.nih.gov

Reduced hypoglycemia risk with insulin glargine: a meta-analysis comparing insulin glargine with human NPH insulin in type 2 diabetes. [2022]

3. Belgium pubmed.ncbi.nlm.nih.gov

[Medication of the month. Insulin glargine (Lantus)]. [2015]

4. England pubmed.ncbi.nlm.nih.gov

The effects of insulin glargine treatment and an educational programme on glycaemic control in type 2 diabetes patients in clinical practice. [2015]

5. Germany pubmed.ncbi.nlm.nih.gov

Efficacy and treatment satisfaction of once-daily insulin glargine plus one or two oral antidiabetic agents versus continuing premixed human insulin in patients with type 2 diabetes previously on long-term conventional insulin therapy: the Switch pilot study. [2022]

6. Germany pubmed.ncbi.nlm.nih.gov

Efficacy and treatment satisfaction of once-daily insulin glargine plus one or two oral antidiabetic agents versus continuing premixed human insulin in patients with Type 2 diabetes previously on long-term conventional insulin therapy: the SWITCH Pilot Study. [2022]

7. England pubmed.ncbi.nlm.nih.gov

Efficacy and safety of MK-1293 insulin glargine compared with originator insulin glargine (Lantus) in type 1 diabetes: A randomized, open-label clinical trial. [2022]