Weekly vs Daily Insulin for Type 2 Diabetes

Recruiting at 73 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

404 Participants Needed

Trial Summary

What is the purpose of this trial?

This study compares insulin icodec, a new insulin taken once a week, to insulin glargine, an insulin taken once a day. The study medicine will be investigated in participants with type 2 diabetes. Participants will either get insulin icodec or insulin glargine. Which treatment participants get is decided by chance. Insulin icodec is the new medicine being tested, while insulin glargine is already approved and can be prescribed by doctors. Participants will get one injection of insulin icodec once a week, or one injection of insulin glargine once a day, depending on the treatment group participants are assigned into. Participants will use a pen with a small needle to inject the medicine under participants skin into participants thigh, upper arm or stomach.The study will last for about 9 months, but participants will only be taking the study medicine for 6 months.

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.

What data supports the effectiveness of the drug Insulin glargine, Lantus, Insulin glargine, Glargine, Insulin icodec for treating type 2 diabetes?

Research shows that weekly insulin icodec is as effective as daily insulin glargine in controlling blood sugar levels in people with type 2 diabetes. Additionally, insulin glargine has been shown to provide effective blood sugar control with a lower risk of low blood sugar episodes compared to other insulins. ^{1 2 3 4 5}

How does the drug Insulin icodec differ from other treatments for type 2 diabetes?

Insulin icodec is unique because it is a once-weekly insulin, unlike traditional insulins like insulin glargine, which are taken daily. This weekly schedule can make it more convenient for patients to manage their diabetes. ^{1 2 3 5 6}

Research Team

Clinical Transparency (dept. 2834)

Principal Investigator

Novo Nordisk A/S

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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

References

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

In uncontrolled T2DM treated with a basal-bolus insulin regimen, weekly icodec was noninferior to daily glargine for HbA1c at 26 wk. [2023]

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

Once-weekly Insulin Icodec as Compared to Once-daily Basal Insulins: A Meta-analysis. [2023]

3. 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]

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

In T2DM uncontrolled with noninsulin glucose-lowering agents, weekly icodec reduced HbA1c vs. daily glargine at 52 wk. [2023]

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

Switching to Once-Weekly Insulin Icodec Versus Once-Daily Insulin Glargine U100 in Type 2 Diabetes Inadequately Controlled on Daily Basal Insulin: A Phase 2 Randomized Controlled Trial. [2022]

6. Belgium pubmed.ncbi.nlm.nih.gov

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