Investigation of Clinical Comparability of Semaglutide Drug Products Based on the Proposed and the Approved Drug Substance Manufacturing Processes in Participants With Type 2 Diabetes

Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 3
SUMMARY

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).

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 64
Healthy Volunteers: No
View:

• 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).

Locations
United States
Florida
Novo Nordisk Investigational Site
Recruiting
Pembroke Pines
Contact Information
Primary
Novo Nordisk
clinicaltrials@novonordisk.com
(+1) 866-867-7178
Time Frame
Start Date: August 3, 2022
Estimated Completion Date: July 27, 2023
Participants
Target number of participants: 332
Treatments
Experimental: Semaglutide J
Participants will initially receive 0.25 milligrams (mg) subcutaneous injections of semaglutide J once weekly (OW) and the dose will be then escalated once in 4 weeks for 8 weeks until the target maintenance dose of 1.0 mg is reached which will be maintained for a period of 20 weeks. Metformin will be considered as background therapy during the trial.
Active Comparator: Semaglutide B
Participants will initially receive 0.25 mg subcutaneous injections of semaglutide B OW and the dose will be then escalated once in 4 weeks for 8 weeks until the target maintenance dose of 1.0 mg is reached which will be maintained for a period of 20 weeks. Metformin will be considered as background therapy during the trial.
Related Therapeutic Areas
Sponsors
Leads: Novo Nordisk A/S

This content was sourced from clinicaltrials.gov

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