Efficacy and Safety of Semaglutide Once Weekly Versus Insulin Glargine Once Daily as add-on to Metformin With or Without Sulphonylurea in Insulin-naïve Subjects With Type 2 Diabetes

(SUSTAIN™ 4 Trial)

Recruiting in Palo Alto (17 mi)

+207 other locations

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 trial is conducted in Africa, North and South America, Asia and Europe. The purpose of the trial is to compare the effect of once-weekly dosing of two dose levels of semaglutide versus insulin glargine once-daily on glycaemic control after 30 weeks of treatment in insulin-naïve subjects with type 2 diabetes.

Research Team

Global Clinical Registry (GCR, 1452)

Principal Investigator

Novo Nordisk A/S

Eligibility Criteria

Inclusion Criteria

Male or female, 18 years or older at the time of signing informed consent

Insulin-naïve subjects diagnosed with type 2 diabetes and on stable diabetes treatment with metformin or metformin and SU (metformin 1500 mg or higher or maximum tolerated dose and SU half of maximum allowed dose according to national label or higher) for at least 90 days before screening. Stable is defined as unchanged medication and unchanged dose

HbA1c 7.0 - 10.0% (53 - 86 mmol/mol) both inclusive

Treatment Details

Interventions

• Insulin Glargine (Insulin)
• Semaglutide (Glucagon-like peptide-1 (GLP-1) receptor agonist)

Participant Groups

Group I: Semaglutide 1.0 mg/week Experimental Treatment 1 Intervention

Group II: Semaglutide 0.5 mg/week Experimental Treatment 1 Intervention

Group III: Insulin glargine Active Control 1 Intervention

Insulin Glargine is already approved in Canada, Japan, China, Switzerland for the following indications:

Approved in Canada as Lantus for:

• Type 1 diabetes
• Type 2 diabetes

Approved in Japan as Lantus for:

• Type 1 diabetes
• Type 2 diabetes

Approved in China as Lantus for:

• Type 1 diabetes
• Type 2 diabetes

Approved in Switzerland as Lantus for:

• Type 1 diabetes
• Type 2 diabetes

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