Semaglutide + Low-Dose Insulin Glargine for Type 2 Diabetes

Recruiting at 218 trial locations

Overseen By Novo Nordisk

Age: 18+

Sex: Any

Travel: May Be Covered

Trial Phase: Phase 3

Sponsor: Novo Nordisk A/S

Must be taking: Metformin, Basal insulin

Disqualifiers: Uncontrolled retinopathy, Type 1 diabetes, Pancreatitis, Renal impairment, 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: 9

Duration: 40 weeks

568 Participants Needed

Trial Summary

What is the purpose of this trial?

This study compares semaglutide, together with a lower dose of insulin glargine, to a higher dose of insulin glargine in participants with type 2 diabetes. The study looks at how well the study medicines control blood glucose levels. Participants will either get semaglutide together with a lower dose of insulin glargine or a higher dose of insulin glargine. The study will last for about 47 weeks (approximately 11 months). Participants will have 9 clinic visits, 15 phone/video calls and 1 home visit. Participants will be asked to wear a sensor that measures their blood sugar all the time in 2 periods of 10 days during the study.

Research Team

Clinical Transparency (dept. 2834)

Principal Investigator

Novo Nordisk A/S

Eligibility Criteria

This trial is for adults with type 2 diabetes who've been on once-daily insulin for at least 3 months, have a BMI of 25 or more, and stable metformin use. Not eligible if they have unstable diabetic eye disease, severe kidney issues, recent pancreatitis, history of ketoacidosis, unawareness of low blood sugar episodes, or certain other conditions.

Inclusion Criteria

I have been using insulin daily for at least 3 months.

I have been taking the same dose of metformin for at least 3 months.

Is your Body Mass Index (BMI) 25 or higher?

Exclusion Criteria

I have been using insulin glargine at 40 units or less daily for over 90 days.

I was diagnosed with Type 2 Diabetes more than 6 months ago.

Glycated haemoglobin (HbA1c) of 7-9 percentage [(53-75 millimoles per mole (mmol/mol)] (both inclusive) as assessed by central laboratory on the day of screening.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive semaglutide with a lower dose of insulin glargine or a higher dose of insulin glargine alone to control blood glucose levels

40 weeks

9 clinic visits, 15 phone/video calls, 1 home visit

Follow-up

Participants are monitored for safety and effectiveness after treatment

4-7 weeks

Treatment Details

Interventions

• Insuline glargine (reduced)
• Insuline glargine (titrated)
• Insuline glargine U100 (reduced)
• Insuline glargine U100 (titrated)
• Semaglutide

Trial Overview The study compares semaglutide with a lower dose of insulin glargine versus a higher dose of insulin glargine alone in controlling blood glucose over about 11 months. Participants will be monitored through clinic visits and continuous glucose sensors during the study.

Participant Groups

Group I: Insuline glargine U100 (reduced) + semaglutide Experimental Treatment 2 Interventions

Participants will initially receive 0.25 milligrams (mg) once-weekly semaglutide subcutaneously (s.c.) and the dose will be gradually escalated to 2 mg as an add-on to dose-reduced insulin glargine s.c. given once-daily. Insulin glargine U100 will be reduced by 10 U at the initiation of semaglutide and then again at each semaglutide dose escalation. Insulin glargine dose will be adjusted based on the mean of three pre-breakfast self-measured plasma glucose (SMPG) values (target SMPG: 4.4-7.2 millimoles per litre (mmol/L)).

Group II: Insuline glargine U100 (titrated) Active Control 1 Intervention

Participants will receive titrated insuline glargine U100 s.c. once-daily. Insulin glargine U100 dose will be adjusted based on the mean of three pre-breakfast SMPG values (target SMPG: 4.4-7.2 mmol/L).

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