A Research Study to Compare Two Semaglutide Medicines in People With Type 2 Diabetes

Completed · Phase 3

Conditions studied: Diabetes Mellitus, Type 2

In brief

The study compares two semaglutide medicines and looks at how well they control blood sugar levels, in participants with type 2 diabetes (T2D). Participants will either get the currently available semaglutide or the semaglutide which is produced through a new manufacturing process. Participants need to take one injection of semaglutide once a week, on the same day of every week. Participants will have a total of 11 clinic visits and the study will last for about 35 weeks (approximately 8 months).

Key facts

Study ID

NCT05478252

Run by

Novo Nordisk A/S

People needed

388

Starts

2022-08-03

Expected to finish

2023-09-18

Last updated by the study team

2025-12-12

Who can join

Age: 18 and older, up to 64. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Diagnosed with type 2 diabetes (T2D) mellitus greater than equal to (≥) 180 days before screening.
• Stable daily dose(s) ≥ 90 days prior to the day of screening of metformin ≥ 1500 milligrams (mg) or maximum tolerated or effective dose.
• HbA1c of 7.0-10.5 percentage (%) [53-91.3 millimoles per mole (mmol/mol)] (both inclusive).

You may not qualify if…

• Known or suspected hypersensitivity to study intervention(s) or related products.
• Treatment with any medication for the indication of diabetes or obesity other than stated in the inclusion criteria within 90 days before screening. However, short term insulin treatment for a maximum of 14 days and prior insulin treatment for gestational diabetes are allowed.
• Uncontrolled and potentially unstable diabetic retinopathy or maculopathy. Verified by a fundus examination performed within 90 days before screening or in the period between screening and randomisation. Pharmacological pupil-dilation is a requirement unless using a digital fundus photography camera specified for nondilated examination.

Where it is running

• FDRC — Costa Mesa, California, United States
• Velocity Clinical Research San Diego — La Mesa, California, United States
• Velocity Clin Res Los Angeles — Los Angeles, California, United States
• LCGK Research — San Carlos, California, United States
• San Diego Family Care_San Diego — San Diego, California, United States
• Encompass Clinical Research_Spring Valley — Spring Valley, California, United States
• Med Partners, Inc. — Toluca Lake, California, United States
• University Clin Investigators — Tustin, California, United States
• Diablo Clinical Research, Inc. — Walnut Creek, California, United States
• Innovative Research of W Florida Inc. — Clearwater, Florida, United States
• Innovative Research of W FL — Clearwater, Florida, United States
• Alliance for Multispec Res — Coral Gables, Florida, United States
• Encore Medical Research LLC — Hollywood, Florida, United States
• New Horizon Research Center — Miami, Florida, United States
• Reyes Clinical Research, Inc — Miami, Florida, United States
• International Research Associates, LLC_Miami — Miami, Florida, United States
• South Broward Research LLC — Miramar, Florida, United States
• Adult Medicine of Lake County, Inc. — Mt. Dora, Florida, United States
• Omega Research Consultants LLC — Orlando, Florida, United States
• South Broward Research LLC — Pembroke Pines, Florida, United States
• Progressive Medical Research — Port Orange, Florida, United States
• CVS Store Number: 7689 — Atlanta, Georgia, United States
• CVS Store Number: 05520 — Savannah, Georgia, United States
• Elite Clinical Trials — Blackfoot, Idaho, United States
• Prime Medical Group, LLC — Gilbert, Arizona, United States

Full record on ClinicalTrials.gov

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