Weekly vs Daily Insulin for Type 2 Diabetes

Recruiting at 73 trial locations

Overseen By Novo Nordisk

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 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.

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.

Treatment Details

Interventions

• Insulin glargine (Insulin)
• Insulin icodec (Insulin)

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 Canada, Japan, China, Switzerland for the following indications:

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