Weekly vs Daily Insulin for Type 2 Diabetes

No longer recruiting at 87 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, thyroid hormones, corticosteroids

Disqualifiers: Diabetic ketoacidosis, myocardial infarction, 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: 26 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if a new once-a-week insulin, called insulin icodec, is as effective as the daily insulin glargine in managing type 2 diabetes. It includes two groups: one using the weekly insulin icodec and the other using the daily insulin glargine. The trial seeks participants who have had type 2 diabetes for at least six months, use insulin daily, and have a BMI of 40 or less. Participants will inject the insulin under their skin with a pen for six months. As a Phase 3 trial, this study represents the final step before FDA approval, offering participants the opportunity to contribute to potentially groundbreaking diabetes treatment.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop your current medications. However, it mentions that participants should not anticipate starting or changing medications that affect weight or glucose for more than 14 days. It's best to discuss your specific medications with the trial team.

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

Previous studies have shown that insulin icodec, taken once a week, has a safety profile similar to daily insulin glargine. Research indicates that both treatments generally produce similar safety outcomes. However, insulin icodec resulted in more instances of low blood sugar compared to glargine. Despite this, insulin icodec maintained a favorable side-effect profile, with no unexpected issues reported. This suggests that insulin icodec is generally well-tolerated in humans, similar to the already-approved insulin glargine. ^{1 2 3 4 5}

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

Researchers are excited about Insulin icodec because it offers a unique approach to managing Type 2 diabetes by requiring only a once-weekly injection, compared to the current standard of daily insulin injections like Insulin glargine. This new delivery method could significantly improve convenience and adherence for patients. Additionally, Insulin icodec is designed to maintain stable blood sugar levels over a longer period, potentially reducing the risk of fluctuations and enhancing overall blood sugar control.

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

In this trial, participants will receive either insulin icodec, administered once weekly, or insulin glargine, administered once daily. Studies have shown that insulin icodec lowers blood sugar levels more effectively than daily insulin glargine. In previous trials, more participants reached their blood sugar targets with icodec compared to daily insulin. Many found it easier to adhere to icodec due to fewer required injections. The once-a-week format was popular, with 93.7% of users preferring it over daily shots. Overall, insulin icodec offers a promising new option for managing type 2 diabetes. ^{1 5 6 7 8}

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 adults with type 2 diabetes who are currently managing their condition with daily basal insulin. Participants should be interested in potentially switching to a new weekly insulin option.

Inclusion Criteria

HbA1c from 7.0-10.0% (53.0-85.8 mmol/mol) at screening confirmed by central laboratory analysis

I was diagnosed with type 2 diabetes more than 6 months ago.

Body mass index (BMI) must be ≤ 40.0 kg/m^2

Exclusion Criteria

I have unstable diabetic eye problems.

I have not had diabetic ketoacidosis in the last 3 months.

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

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

4 weeks

Treatment

Participants receive either insulin icodec once weekly or insulin glargine once daily for 6 months

26 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

5 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Insulin glargine
• Insulin icodec

Trial Overview The study compares two types of insulin: Insulin Icodec, which is taken once a week, and Insulin Glargine, which is taken daily. The goal is to see if the new weekly insulin can better control blood sugar levels than the daily one.

How Is the Trial Designed?

Group I: Insulin icodec Experimental Treatment 2 Interventions

Participants will receive Insulin icodec subcutaneously once weekly.

Group II: Insulin glargine U100 Active Control 2 Interventions

Participants will receive Insulin glargine subcutaneously once daily.

Insulin glargine is already approved in European Union, United States, Canada, Japan, China, Switzerland for the following indications:

Approved in European Union as Lantus for:

• Type 1 diabetes mellitus
• Type 2 diabetes mellitus

Approved in United States as Lantus for:

• Type 1 diabetes mellitus
• Type 2 diabetes mellitus

Approved in Canada as Lantus for:

• Type 1 diabetes mellitus
• Type 2 diabetes mellitus

Approved in Japan as Lantus for:

• Type 1 diabetes mellitus
• Type 2 diabetes mellitus

Approved in China as Lantus for:

• Type 1 diabetes mellitus
• Type 2 diabetes mellitus

Approved in Switzerland as Lantus for:

• Type 1 diabetes mellitus
• Type 2 diabetes mellitus

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. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/38192022/

Efficacy and safety of once-weekly insulin icodec in type 2 ... Once-weekly insulin icodec showed a better HbA1c reduction with a higher proportion of patients achieving HbA1c targets in comparison with ...

2. sciencedirect.com sciencedirect.com/science/article/pii/S0168822724007952

Improved treatment satisfaction with once-weekly insulin ... In ONWARDS 2, 93.7 % of icodec users preferred once-weekly over once-daily basal insulin, mainly owing to less frequent injections and ease of use. ONWARDS 1 ...

3. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/40853353/

Cost-effectiveness of insulin icodec for the treatment of type ... Compared to insulin glargine U100 and U300, insulin icodec was associated with ICURs of $17,876, $20,844, and $73,253; and $6,439, $8,623, and ...

4. dom-pubs.onlinelibrary.wiley.com dom-pubs.onlinelibrary.wiley.com/doi/full/10.1111/dom.16328

Efficacy and hypoglycaemia outcomes with once‐weekly ... The efficacy and hypoglycaemia profile of icodec versus once-daily comparators was generally consistent across ONWARDS trials irrespective of background GLP-1 ...

5. academic.oup.com academic.oup.com/jcem/article/110/11/e3596/8086419

Efficacy and Hypoglycemia Profile of Once-weekly Insulin ... Here, we describe a post hoc analysis of data from ONWARDS 1 to 5 that assessed, by trial, the efficacy and hypoglycemia profile of once-weekly icodec vs OD ...

6. dom-pubs.onlinelibrary.wiley.com dom-pubs.onlinelibrary.wiley.com/doi/10.1111/dom.15408

Efficacy and safety of once‐weekly insulin icodec in type 2 ... The safety profile was comparable between insulin icodec and glargine U100, whereas insulin icodec reported higher incidence of hypoglycaemia ...

7. journals.lww.com journals.lww.com/annals-of-medicine-and-surgery/fulltext/2025/07000/once_weekly_insulin_icodec_vs__daily_insulin.56.aspx

Once-weekly insulin icodec vs. daily insulin glargine in... Safety outcomes: Both once-weekly insulin icodec and daily insulin glargine displayed similar safety profiles, including comparable risks of ...

8. nejm.org nejm.org/doi/full/10.1056/NEJMoa2022474

Once-Weekly Insulin for Type 2 Diabetes without Previous ... Insulin icodec had a favorable side-effect profile, and no unexpected safety findings occurred. In our trial, the blinded design with a double-dummy strategy ...