Weekly Insulin for Type 2 Diabetes

Recruiting at 72 trial locations

Age: 18+

Sex: Any

Trial Phase: Phase 4

Sponsor: Novo Nordisk A/S

Disqualifiers: Pregnancy, Hypersensitivity, Recent study, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

Duration: 52 weeks

586 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to compare the effectiveness of a weekly insulin, insulin icodec, in controlling blood sugar against daily basal insulins like insulin glargine in people with type 2 diabetes. Participants will receive either the weekly insulin or one of the daily options for about 13 months. The trial targets individuals who have had type 2 diabetes for at least six months, are currently on certain diabetes medications, and need to start using insulin to better manage their blood sugar. As a Phase 4 trial, this research seeks to understand how the already FDA-approved and effective treatment benefits more patients, offering an opportunity to contribute to broader advancements in diabetes care.

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

The trial does not specify that you need to stop your current diabetes medications. It seems you can continue taking them while participating.

What is the safety track record for these treatments?

Research shows that once-a-week insulin icodec is safe and effective for patients. Studies have found it to be as safe as daily insulin treatments, with no significant difference in the risk of side effects like low blood sugar. Patients using insulin icodec report greater satisfaction, likely due to the convenience of weekly dosing. Overall, insulin icodec appears to be a safe and effective method for managing blood sugar in people with type 2 diabetes. ^{1 2 3 4 5}

Why are researchers enthusiastic about this study treatment?

Insulin icodec is unique because it offers the convenience of a once-weekly injection, unlike the standard basal insulin analogues that require daily injections. This less frequent dosing could greatly enhance adherence and quality of life for people managing type 2 diabetes. Researchers are excited about the potential for Insulin icodec to maintain effective blood sugar control with fewer injections, making diabetes management simpler and more flexible.

What is the effectiveness track record for insulin icodec in treating type 2 diabetes?

Studies have shown that once-weekly insulin icodec, which participants in this trial may receive, works well for people with type 2 diabetes. It has been found to lower HbA1c levels, a measure of average blood sugar over time, more effectively than daily insulin shots. More patients using icodec reached their blood sugar goals. People using icodec also reported greater satisfaction, mainly due to fewer required injections. Research indicates that it works well regardless of kidney health and may have a lower risk of causing low blood sugar. Meanwhile, another group in this trial will receive daily injections of basal insulin analogues, serving as an active comparator. ^{1 2 4 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?

Adults with type 2 diabetes are eligible for this study. Participants will be using either a new weekly insulin (icodec) or standard daily basal insulins. The trial lasts about 13 months, and candidates must meet specific health criteria to join.

Inclusion Criteria

I am currently taking medication for my blood sugar that is not insulin.

My doctor thinks I need to start or increase my insulin.

Recorded HbA1c value ≥7% within the last 90 days prior to randomization

Exclusion Criteria

Known or suspected hypersensitivity to study intervention(s) or related products

Previous participation in this study (defined as signed informed consent)

Any disorder which in the investigator's opinion might jeopardize participant's safety

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either weekly insulin icodec or daily basal insulin analogues for blood sugar management

52 weeks

Weekly or daily administration as per assigned treatment

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Insulin Icodec

Trial Overview The trial is testing the effectiveness of insulin icodec, which is taken once a week, against daily basal insulins like glargine, detemir, or degludec in maintaining blood sugar levels in adults with type 2 diabetes.

How Is the Trial Designed?

Group I: Insulin icodec Experimental Treatment 1 Intervention

Participants will receive subcutaneous (s.c) injection of once weekly insulin icodec.

Group II: Basal insulin analogues Active Control 1 Intervention

Participants will receive once daily s.c. injection of basal insulin analogues.

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. dom-pubs.onlinelibrary.wiley.com dom-pubs.onlinelibrary.wiley.com/doi/full/10.1111/dom.16231

Efficacy and hypoglycaemia outcomes with once‐weekly ... Efficacy and hypoglycaemia outcomes of icodec versus once-daily comparators were generally consistent among adults with T2D, regardless of kidney function.

4. diabetesjournals.org diabetesjournals.org/diabetes/article/73/Supplement_1/1882-LB/155182/1882-LB-Efficacy-and-Safety-Outcomes-with-Once

1882-LB: Efficacy and Safety Outcomes with Once-Weekly ... Conclusion: Similar to degludec, when used as part of a basal-bolus regimen in T1D, once-weekly icodec may offer a lower risk of hypoglycemia ...

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 meta-analysis showed that once-weekly insulin icodec had higher glycated haemoglobin (HbA1c) reduction [mean difference −0.17%, 95% ...

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 ...