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Diabetes Mellitus, Type 2Phase 3NCT05478252

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

A Phase 3 study testing Semaglutide J and Semaglutide B in people with Diabetes Mellitus, Type 2, run by Novo Nordisk A/S at 104 sites in 5 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 18 to 64 years
Conditions the study is for
Diabetes Mellitus, Type 2
What is being tested?
Semaglutide J and Semaglutide B
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
388 participants
Where
104 sitesin 5 countries
Study dates
3 Aug 2022to 18 Sep 2023
Phase
Phase 3
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 64 years
  • All sexes
  • No healthy volunteers
  • Adult

Who may be able to join

  • 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).

Who cannot join

  • 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.

Trial locations and contacts

104 sites in 5 countries.

104 sites in 5 countries

United States55 sites

  • CVS Store Number: 7689

    Atlanta, Georgia, 30329-4015

  • Elligo Clin Res Centre

    Austin, Texas, 78704

  • Elite Clinical Trials

    Blackfoot, Idaho, 83221

  • Innovative Research of W Florida Inc.

    Clearwater, Florida, 33756

  • Innovative Research of W FL

    Clearwater, Florida, 33756

  • Alliance for Multispec Res

    Coral Gables, Florida, 33134

  • FDRC

    Costa Mesa, California, 92627

  • Velocity Clinical Res-Dallas

    Dallas, Texas, 75230

  • UT Southwestern Med Cntr

    Dallas, Texas, 75390-9302

  • Elite Research Center

    Flint, Michigan, 48532

  • Prime Medical Group, LLC

    Gilbert, Arizona, 85296

  • Macoupin Research Group

    Gillespie, Illinois, 62033

  • PharmQuest Life Sciences LLC

    Greensboro, North Carolina, 27408

  • Encore Medical Research LLC

    Hollywood, Florida, 33024

  • Southwest Clinical Trials

    Houston, Texas, 77081

  • Velocity Clinical Research San Diego

    La Mesa, California, 91942

  • The Research Group of Lexington LLC

    Lexington, Kentucky, 40503

  • Velocity Clin Res Los Angeles

    Los Angeles, California, 90017

  • Albert J Weisbrot

    Mason, Ohio, 45040-6815

  • Advanced Med Res Maumee

    Maumee, Ohio, 43537

  • Solaris Clinical Research

    Meridian, Idaho, 83646

  • New Horizon Research Center

    Miami, Florida, 33165

  • Reyes Clinical Research, Inc

    Miami, Florida, 33175

  • International Research Associates, LLC_Miami

    Miami, Florida, 33183

  • South Broward Research LLC

    Miramar, Florida, 33027

  • Montana Medical Research

    Missoula, Montana, 59808

  • Adult Medicine of Lake County, Inc.

    Mt. Dora, Florida, 32757

  • BTC of New Bedford, LLC

    New Bedford, Massachusetts, 02740

  • Omega Research Consultants LLC

    Orlando, Florida, 32806

  • MD Medical Research

    Oxon Hill, Maryland, 20745

  • Tapia Internal Medicine Clinic

    Paris, Texas, 75462

  • South Broward Research LLC

    Pembroke Pines, Florida, 33027

  • Tristar Clin Investigations, PC

    Philadelphia, Pennsylvania, 19114

  • Progressive Medical Research

    Port Orange, Florida, 32127

  • CVS Store Number: 01396

    Reston, Virginia, 20191-4327

  • CVS Store Number: 1537

    Richmond, Virginia, 23230-3005

  • Univ Of Texas Hlth Science Cntr

    San Antonio, Texas, 78229

  • VIP Trials_San Antonio

    San Antonio, Texas, 78230

  • VIP Trials

    San Antonio, Texas, 78230

  • LCGK Research

    San Carlos, California, 94070

  • San Diego Family Care_San Diego

    San Diego, California, 92111

  • CVS Store Number: 05520

    Savannah, Georgia, 31405-6901

  • Spartanburg Medical Research

    Spartanburg, South Carolina, 29303

  • Encompass Clinical Research_Spring Valley

    Spring Valley, California, 91978

  • Dwayne O. Williams, M.D., P.A.

    Sugar Land, Texas, 77479

  • Sugar Lakes Family Practice PA

    Sugar Land, Texas, 77479

  • Med Partners, Inc.

    Toluca Lake, California, 91602

  • Martin Diagnostic Clinic

    Tomball, Texas, 77375

  • Arcturus Healthcare, PLC.

    Troy, Michigan, 48098

  • University Clin Investigators

    Tustin, California, 92780

  • Diablo Clinical Research, Inc.

    Walnut Creek, California, 94598

  • Clin Invest Spec, Inc

    Wauconda, Illinois, 60084

  • Wenatchee Valley Hospital and Clinics

    Wenatchee, Washington, 98801-2028

  • Whiteville Medical Assoc, PA

    Whiteville, North Carolina, 28472

  • N.Y. Family Practice Physicians

    Woodhaven, New York, 11421

Other trials in United States

Canada21 sites

  • Centricity Research Brampton

    Brampton, Ontario, L6S 0C6

  • LMC Clin Res Inc. Thornhill

    Concord, Ontario, L4K 4M2

  • Medical Trust Clinics, Inc.

    Courtice, Ontario, L1E2J5

  • Centricity Research Etobicoke

    Etobicoke, Ontario, M9R 4E1

  • Nova Scotia Hlth Halifax

    Halifax, Nova Scotia, B3H 2Y9

  • Wharton Med Clin Trials

    Hamilton, Ontario, L8L 5G8

  • Manna Research Quebec

    Lévis, Quebec, G6W 0M5

  • Milestone Research

    London, Ontario, N5W 6A2

  • G.A. Research Associates Ltd.

    Moncton, New Brunswick, E1G 1A7

  • Recherche GCP Research

    Montreal, Quebec, H1Y 3H5

  • LMC Clin Rsrch Inc. (Montreal)

    Montreal, Quebec, H4T 1Z9

  • Centricity Research New Minas

    New Minas, Nova Scotia, B4N 3R7

  • Centricity Res Pointe-Claire

    Pointe-Claire, Quebec, H9R 4S3

  • Manna Research Inc.

    Pointe-Claire, Quebec, H9R 4S3

  • Care Clinic

    Red Deer, Alberta, T4P 1K4

  • Centricity Research Ville St. Laurent VSL

    Saint-Laurent, Quebec, H4T 1Z9

  • Bluewater Clin Res Group,Inc

    Sarnia, Ontario, N7T 4X3

  • Canadian Centre for Research on Diabetes_Smiths Falls

    Smiths Falls, Ontario, K7A 4W8

  • Ocean West Research Clinic

    Surrey, British Columbia, V3Z 2N6

  • LMC Endo Centres Ltd.(Bayview)

    Toronto, Ontario, M4G 3E8

  • LMC Manna Research

    Toronto, Ontario, M4G 3E8

Other trials in Canada

Poland12 sites

  • Osteo Medic s.c. Artur Racewicz Jerzy Supronik

    Bialystok, 15-351

  • NZOZ Specjalistyczny Osrodek Internistyczno-Diabetologiczny Małgorzata Arciszewska

    Bialystok, 15-435

  • M2M Badania Kliniczne

    Chorzów, 41-500

  • NZOZ Gdanska Poradnia Cukrzycowa Sp.z o.o.

    Gdansk, 80-858

  • Krakowskie Centrum Medyczne Sp. z o.o.

    Krakow, 31-501

  • Beata Miklaszewicz&Dariusz Dabrowski "CARDIAMED" s.j.

    Legnica, Lower Silesian Voivodeship, 59-220

  • FutureMeds Sp. z o.o. Lodz

    Lodz, 91-363

  • ETG Lublin

    Lublin, Lublin Voivodeship, 20-412

  • ETG Lublin

    Lublin, 20-412

  • Centrum Medyczne "Diabetika"

    Radom, 26-600

  • PANSTWOWY INSTYTUT MEDYCZNY MSWiA

    Warsaw, 02-507

  • FutureMeds Sp. z o.o.

    Wroclaw, 50-088

Other trials in Poland

South Africa9 sites

  • Medi-Clinic Bloemfontein

    Bloemfontein, Free State, 9301

  • Dr A Amod

    Durban, KwaZulu-Natal, 4092

  • Precise Clinical Solutions (Pty) Ltd

    Durban, KwaZulu-Natal, 4092

  • Dr Pillay's Rooms

    Durban, KwaZulu-Natal, 4450

  • Shop#1 Health Emporium

    Midrand, Gauteng, 1685

  • Prinshof Medical Campus

    Pretoria, Gauteng, 0002

  • Jongaie Research

    Pretoria, Gauteng, 0183

  • Clinical Trial Systems (CTC)

    Pretoria, Gauteng, 0186

  • Moriana Clinical Research

    Winnie Mandela, Free State, 9400

Other trials in South Africa

Slovakia7 sites

  • Diabetologicka ambulancia DIASTYLE s.r.o.

    Banská Bystrica, 97401

  • Diabetologicka ambulancia DIAMO s.r.o.

    Kežmarok, 06001

  • IVAMEDIC s.r.o.

    Košice, 040 11

  • DIA - SANTMART, s.r.o., Ambulancia diabetologie a poruch latkovej premeny a vyzivy

    Martin, 036 01

  • Diabetologicka ambulancia MUDr. Iveta Markova s.r.o

    Nitra, 94911

  • MUDr. Jan Culak, s.r.o.

    Prievidza, 97101

  • MEDI-DIA s.r.o.

    Sabinov, 08301

Other trials in Slovakia

About this study

Official title: 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).

Being tested
Semaglutide J, Semaglutide B
Medical subject headings
Diabetes Mellitus, Type 2

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Semaglutide JDrug

    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).

  • Semaglutide BDrug

    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).

Study groups in NCT05478252
Study groupRoleWhat they receive
Semaglutide JExperimentalParticipants 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.
Receives: Drug: Semaglutide J
Semaglutide BActive comparatorParticipants 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.
Receives: Drug: Semaglutide B

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: From baseline (week 0) to end of treatment (week 28)

Secondary outcomes (8)

  1. 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.

    Measured: From baseline (week 0) to end of treatment (week 28)

  2. 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.

    Measured: From the time of first dosing (week 0) to end of study (week 33)

  3. 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.

    Measured: From baseline (week 0) to end of study (week 33)

  4. 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.

    Measured: From baseline (week 0) to end of study (week 33)

  5. 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).

    Measured: From baseline (week 0) to end of study (week 33)

  6. 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.

    Measured: At week 33

  7. Anti-semaglutide Antibodies Level Measured as Percentage (%) Bound/Total

    Anti-semaglutide antibodies level measured as %Bound/Total at week 33 is presented.

    Measured: At week 33

  8. Anti-semaglutide Antibodies Level (Measured as Titre)

    Anti-semaglutide antibodies level measured as titre at week 33 is presented.

    Measured: At week 33

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted28 Jul 2022
  2. Study start3 Aug 2022
  3. Primary completion9 Aug 2023
  4. Study completion18 Sep 2023

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Triple blind
Who is masked
Participant, Care provider, Investigator
Enrolment
388 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05478252
Sponsor's protocol ID
NN9535-4820
Other IDs
U1111-1266-2391, 2021-001501-69
Status last verified
Nov 2025
First submitted
26 Jul 2022
Last updated
12 Dec 2025
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: According to the Novo Nordisk disclosure commitment on novonordisk-trials.com

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Semaglutide J and Semaglutide B in people with Diabetes Mellitus, Type 2, run by Novo Nordisk A/S at 104 sites in 5 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 12 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 104 sites in United States, Canada, Poland, South Africa, Slovakia. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 9 Oct 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in Glycosylated Haemoglobin (HbA1c) (time frame: From baseline (week 0) to end of treatment (week 28)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05478252.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Dec 2025.

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