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

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

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).

Study Overview

• Status: Completed
• Conditions: Diabetes Mellitus, Type 2
• Intervention / Treatment: Drug: Semaglutide J; Drug: Semaglutide B

• Study Type: Interventional
• Enrollment (Actual): 388
• Phase: Phase 3

Contacts and Locations

Study Locations

• Canada
  • Alberta
    • Red Deer, Alberta, Canada, T4P 1K4
      • CARe Clinic
  • British Columbia
    • Surrey, British Columbia, Canada, V3Z 2N6
      • Ocean West Research Clinic
  • New Brunswick
    • Moncton, New Brunswick, Canada, E1G 1A7
      • G.A. Research Associates Ltd.
  • Nova Scotia
    • Halifax, Nova Scotia, Canada, B3H 2Y9
      • Nova Scotia Hlth Halifax
    • New Minas, Nova Scotia, Canada, B4N 3R7
      • Centricity Research New Minas
  • Ontario
    • Brampton, Ontario, Canada, L6S 0C6
      • Centricity Research Brampton
    • Concord, Ontario, Canada, L4K 4M2
      • LMC Clin Res Inc. Thornhill
    • Courtice, Ontario, Canada, L1E2J5
      • Medical Trust Clinics, Inc.
    • Etobicoke, Ontario, Canada, M9R 4E1
      • Centricity Research Etobicoke
    • Hamilton, Ontario, Canada, L8L 5G8
      • Wharton Med Clin Trials
    • London, Ontario, Canada, N5W 6A2
      • Milestone Research
    • Sarnia, Ontario, Canada, N7T 4X3
      • Bluewater Clin Res Group,Inc
    • Smiths Falls, Ontario, Canada, K7A 4W8
      • Canadian Centre for Research on Diabetes_Smiths Falls
    • Toronto, Ontario, Canada, M4G 3E8
      • LMC Manna Research
    • Toronto, Ontario, Canada, M4G 3E8
      • LMC Endo Centres Ltd.(Bayview)
  • Quebec
    • Lévis, Quebec, Canada, G6W 0M5
      • Manna Research Quebec
    • Montreal, Quebec, Canada, H4T 1Z9
      • LMC Clin Rsrch Inc. (Montreal)
    • Montreal, Quebec, Canada, H1Y 3H5
      • Recherche GCP Research
    • Pointe-Claire, Quebec, Canada, H9R 4S3
      • Manna Research Inc.
    • Pointe-Claire, Quebec, Canada, H9R 4S3
      • Centricity Res Pointe-Claire
    • Saint-Laurent, Quebec, Canada, H4T 1Z9
      • Centricity Research Ville St. Laurent VSL
• Poland
  • Bialystok, Poland, 15-351
    • Osteo Medic s.c. Artur Racewicz Jerzy Supronik
  • Bialystok, Poland, 15-435
    • NZOZ Specjalistyczny Osrodek Internistyczno-Diabetologiczny Małgorzata Arciszewska
  • Chorzów, Poland, 41-500
    • M2M Badania Kliniczne
  • Gdansk, Poland, 80-858
    • NZOZ Gdanska Poradnia Cukrzycowa Sp.z o.o.
  • Krakow, Poland, 31-501
    • Krakowskie Centrum Medyczne Sp. z o.o.
  • Lodz, Poland, 91-363
    • FutureMeds Sp. z o.o. Lodz
  • Lublin, Poland, 20-412
    • ETG Lublin
  • Radom, Poland, 26-600
    • Centrum Medyczne "Diabetika"
  • Warsaw, Poland, 02-507
    • PANSTWOWY INSTYTUT MEDYCZNY MSWiA
  • Wroclaw, Poland, 50-088
    • Futuremeds sp. z o.o.
  • Lower Silesian Voivodeship
    • Legnica, Lower Silesian Voivodeship, Poland, 59-220
      • Beata Miklaszewicz&Dariusz Dabrowski "CARDIAMED" s.j.
  • Lublin Voivodeship
    • Lublin, Lublin Voivodeship, Poland, 20-412
      • ETG Lublin
• Slovakia
  • Banská Bystrica, Slovakia, 97401
    • Diabetologicka ambulancia DIASTYLE s.r.o.
  • Kežmarok, Slovakia, 06001
    • Diabetologicka ambulancia DIAMO s.r.o.
  • Košice, Slovakia, 040 11
    • IVAMEDIC s.r.o.
  • Martin, Slovakia, 036 01
    • DIA - SANTMART, s.r.o., Ambulancia diabetologie a poruch latkovej premeny a vyzivy
  • Nitra, Slovakia, 94911
    • Diabetologicka ambulancia MUDr. Iveta Markova s.r.o
  • Prievidza, Slovakia, 97101
    • MUDr. Jan Culak, s.r.o.
  • Sabinov, Slovakia, 08301
    • MEDI-DIA s.r.o.
• South Africa
  • Free State
    • Bloemfontein, Free State, South Africa, 9301
      • Medi-Clinic Bloemfontein
    • Winnie Mandela, Free State, South Africa, 9400
      • Moriana Clinical Research
  • Gauteng
    • Midrand, Gauteng, South Africa, 1685
      • Shop#1 Health Emporium
    • Pretoria, Gauteng, South Africa, 0183
      • Jongaie Research
    • Pretoria, Gauteng, South Africa, 0186
      • Clinical Trial Systems (CTC)
    • Pretoria, Gauteng, South Africa, 0002
      • Prinshof Medical Campus
  • KwaZulu-Natal
    • Durban, KwaZulu-Natal, South Africa, 4450
      • Dr Pillay's Rooms
    • Durban, KwaZulu-Natal, South Africa, 4092
      • Dr A Amod
    • Durban, KwaZulu-Natal, South Africa, 4092
      • Precise Clinical Solutions (Pty) Ltd
• United States
  • Arizona
    • Gilbert, Arizona, United States, 85296
      • Prime Medical Group, LLC
  • California
    • Costa Mesa, California, United States, 92627
      • FDRC
    • La Mesa, California, United States, 91942
      • Velocity Clinical Research San Diego
    • Los Angeles, California, United States, 90017
      • Velocity Clin Res Los Angeles
    • San Carlos, California, United States, 94070
      • LCGK Research
    • San Diego, California, United States, 92111
      • San Diego Family Care_San Diego
    • Spring Valley, California, United States, 91978
      • Encompass Clinical Research_Spring Valley
    • Toluca Lake, California, United States, 91602
      • Med Partners, Inc.
    • Tustin, California, United States, 92780
      • University Clin Investigators
    • Walnut Creek, California, United States, 94598
      • Diablo Clinical Research, Inc.
  • Florida
    • Clearwater, Florida, United States, 33756
      • Innovative Research of W Florida Inc.
    • Clearwater, Florida, United States, 33756
      • Innovative Research of W FL
    • Coral Gables, Florida, United States, 33134
      • Alliance for Multispec Res
    • Hollywood, Florida, United States, 33024
      • Encore Medical Research LLC
    • Miami, Florida, United States, 33165
      • New Horizon Research Center
    • Miami, Florida, United States, 33175
      • Reyes Clinical Research, Inc
    • Miami, Florida, United States, 33183
      • International Research Associates, LLC_Miami
    • Miramar, Florida, United States, 33027
      • South Broward Research LLC
    • Mt. Dora, Florida, United States, 32757
      • Adult Medicine of Lake County, Inc.
    • Orlando, Florida, United States, 32806
      • Omega Research Consultants LLC
    • Pembroke Pines, Florida, United States, 33027
      • South Broward Research LLC
    • Port Orange, Florida, United States, 32127
      • Progressive Medical Research
  • Georgia
    • Atlanta, Georgia, United States, 30329-4015
      • CVS Store Number: 7689
    • Savannah, Georgia, United States, 31405-6901
      • CVS Store Number: 05520
  • Idaho
    • Blackfoot, Idaho, United States, 83221
      • Elite Clinical Trials
    • Meridian, Idaho, United States, 83646
      • Solaris Clinical Research
  • Illinois
    • Gillespie, Illinois, United States, 62033
      • Macoupin Research Group
    • Wauconda, Illinois, United States, 60084
      • Clin Invest Spec, Inc
  • Kentucky
    • Lexington, Kentucky, United States, 40503
      • The Research Group of Lexington LLC
  • Maryland
    • Oxon Hill, Maryland, United States, 20745
      • MD Medical Research
  • Massachusetts
    • New Bedford, Massachusetts, United States, 02740
      • BTC of New Bedford, LLC
  • Michigan
    • Flint, Michigan, United States, 48532
      • Elite Research Center
    • Troy, Michigan, United States, 48098
      • Arcturus Healthcare, PLC.
  • Montana
    • Missoula, Montana, United States, 59808
      • Montana Medical Research
  • New York
    • Woodhaven, New York, United States, 11421
      • N.Y. Family Practice Physicians
  • North Carolina
    • Greensboro, North Carolina, United States, 27408
      • PharmQuest Life Sciences LLC
    • Whiteville, North Carolina, United States, 28472
      • Whiteville Medical Assoc, PA
  • Ohio
    • Mason, Ohio, United States, 45040-6815
      • Albert J Weisbrot
    • Maumee, Ohio, United States, 43537
      • Advanced Med Res Maumee
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19114
      • Tristar Clin Investigations, PC
  • South Carolina
    • Spartanburg, South Carolina, United States, 29303
      • Spartanburg Medical Research
  • Texas
    • Austin, Texas, United States, 78704
      • Elligo Clin Res Centre
    • Dallas, Texas, United States, 75230
      • Velocity Clinical Res-Dallas
    • Dallas, Texas, United States, 75390-9302
      • UT Southwestern Med Cntr
    • Houston, Texas, United States, 77081
      • Southwest Clinical Trials
    • Paris, Texas, United States, 75462
      • Tapia Internal Medicine Clinic
    • San Antonio, Texas, United States, 78230
      • VIP Trials
    • San Antonio, Texas, United States, 78230
      • VIP Trials_San Antonio
    • San Antonio, Texas, United States, 78229
      • Univ Of Texas Hlth Science Cntr
    • Sugar Land, Texas, United States, 77479
      • Sugar Lakes Family Practice PA
    • Sugar Land, Texas, United States, 77479
      • Dwayne O. Williams, M.D., P.A.
    • Tomball, Texas, United States, 77375
      • Martin Diagnostic Clinic
  • Virginia
    • Reston, Virginia, United States, 20191-4327
      • CVS Store Number: 01396
    • Richmond, Virginia, United States, 23230-3005
      • CVS Store Number: 1537
  • Washington
    • Wenatchee, Washington, United States, 98801-2028
      • Wenatchee Valley Hospital and Clinics

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 64 years (Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• 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).

Exclusion Criteria:

• 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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.	Drug: Semaglutide J; Participants will initially receive 0.25 mg subcutaneous injections of semaglutide J 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: 0.25 mg (week 1 to week 4), 0.5 mg (week 5 to week 8), 1.0 mg (week 9 to week 28).
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.	Drug: 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: 0.25 mg (week 1 to week 4), 0.5 mg (week 5 to week 8), 1.0 mg (week 9 to week 28).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Glycosylated Haemoglobin (HbA1c)	Change in HbA1c from baseline (week 0) to end of treatment (week 28) is presented. The endpoint was evaluated based on the data from in-study period. The in-study period is defined as the uninterrupted time interval from date of randomisation to date of least contact with trial site.	From baseline (week 0) to end of treatment (week 28)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Body Weight	Change in body weight from baseline (week 0) to end of treatment (week 28) is presented. The endpoint was evaluated based on the data from in-study period. The in-study period is defined as the uninterrupted time interval from date of randomisation to date of least contact with trial site.	From baseline (week 0) to end of treatment (week 28)
Number of Treatment-Emergent Adverse Events (TEAEs)	An AE is any untoward medical occurrence in a clinical study participant that is temporally associated with the use of IMP, whether or not considered related to the IMP. An AE can therefore be any unfavourable and unintended sign (including an abnormal laboratory finding), symptom or disease (new or exacerbated) temporally associated with the use of an IMP. All presented adverse events are TEAE. A TEAE is defined as an adverse event with an onset date (or increase in severity) during the on-treatment observation period. On-treatment observation period is defined as from first drug date until the end of study.	From the time of first dosing (week 0) to end of study (week 33)
Occurrence of Anti-semaglutide Antibodies (Yes/no)	Occurrence of anti-semaglutide antibodies for in-study observation period is presented. The in-study period is defined as the uninterrupted time interval from date of randomisation to date of last contact with trial site. In the reported data 'yes' infers who tested positive for anti-semaglutide antibodies, whereas 'No' infers who tested negative for anti semaglutide antibodies.	From baseline (week 0) to end of study (week 33)
Occurrence of Anti-semaglutide Antibodies With In-vitro Neutralising Effect (Yes/no)	Occurrence of anti-semaglutide antibodies with in-vitro neutralizing effect was to be performed based on positive cross -reactivity to GLP-1. Since there was no sample with positive cross -reactivity to GLP-1, no further analysis was performed for invitro neutralizing effect towards native-GLP1. Therefore, no data is available for this end point. In the reported data 'yes' infers who tested positive for anti-semaglutide antibodies whereas 'No' infers who tested negative for anti-semaglutide antibodies.	From baseline (week 0) to end of study (week 33)
Occurrence of Anti-semaglutide Binding Antibodies Cross-reacting With Endogenous Glucagon Like Peptide-1 (GLP-1) (Yes/no)	Occurrence of anti-semaglutide binding antibodies cross-reacting with endogenous glucagon like peptide-1 (GLP-1) for in-study observation period is presented. The in-study period is defined as the uninterrupted time interval from date of randomisation to date of last contact with trial site. In the reported data 'yes' infers who tested positive for anti-semaglutide binding antibodies cross-reacting with endogenous glucagon like peptide-1 (GLP-1) whereas 'No' infers who tested negative for anti-semaglutide binding antibodies cross-reacting with endogenous glucagon like peptide-1 (GLP-1).	From baseline (week 0) to end of study (week 33)
Occurrence of In-vitro Neutralising Cross-reacting Antibodies to Endogenous GLP-1 (Yes/no)	Occurrence of in-vitro neutralising cross-reacting antibodies to endogenous GLP-1 at week 33 is presented. In the reported data 'yes' infers who tested positive for in-vitro neutralising cross-reacting antibodies to endogenous GLP-1 whereas 'No' infers who tested negative for in-vitro neutralising cross-reacting antibodies to endogenous GLP-1.	At week 33
Anti-semaglutide Antibodies Level Measured as Percentage (%) Bound/Total	Anti-semaglutide antibodies level measured as %Bound/Total at week 33 is presented.	At week 33
Anti-semaglutide Antibodies Level (Measured as Titre)	Anti-semaglutide antibodies level measured as titre at week 33 is presented.	At week 33

Collaborators and Investigators

• Sponsor: Novo Nordisk A/S
• Investigators: Study Director: Clinical Transparency (dept. 2834), Novo Nordisk A/S

Study record dates

Study Major Dates

• Study Start (Actual): August 3, 2022
• Primary Completion (Actual): August 9, 2023
• Study Completion (Actual): September 18, 2023

Study Registration Dates

• First Submitted: July 26, 2022
• First Submitted That Met QC Criteria: July 26, 2022
• First Posted (Actual): July 28, 2022

Study Record Updates

• Last Update Posted (Actual): December 12, 2025
• Last Update Submitted That Met QC Criteria: November 24, 2025
• Last Verified: November 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Endocrine System Diseases; Metabolic Diseases; Glucose Metabolism Disorders; Diabetes Mellitus; Nutritional and Metabolic Diseases; Diabetes Mellitus, Type 2; Hypoglycemic Agents; Physiological Effects of Drugs; Glucagon-Like Peptide-1 Receptor Agonists; Semaglutide
• Other Study ID Numbers: NN9535-4820; U1111-1266-2391 (Other Identifier: World Health Organization (WHO)); 2021-001501-69 (EudraCT Number)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: According to the Novo Nordisk disclosure commitment on novonordisk-trials.com

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No