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

NCT05478252 | Completed Phase 3 Results FDA Drug

• 3 other identifiers: NN9535-4820U1111-1266-23912021-001501-69
• Study Type: interventional
• Target: 388
• Locations: 5 countries
• Sites: 104

Brief 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).

Conditions

Diabetes Mellitus, Type 2

Outcome Measures

Primary Outcomes (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.

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

Secondary Outcomes (8)

• Change in Body Weight

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

• Number of Treatment-Emergent Adverse Events (TEAEs)

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

• Occurrence of Anti-semaglutide Antibodies (Yes/no)

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

• Occurrence of Anti-semaglutide Antibodies With In-vitro Neutralising Effect (Yes/no)

  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)

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

Study Arms (2)

Semaglutide J

EXPERIMENTAL

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

Semaglutide B

ACTIVE COMPARATOR

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

Interventions

Semaglutide J DRUG

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 J

Semaglutide B DRUG

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).

Semaglutide B

Eligibility Criteria

• Age: 18 Years - 64 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

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.
• 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.

Sponsors & Collaborators

• Novo Nordisk A/S: lead

Study Sites (104)

Prime Medical Group, LLC

Gilbert, Arizona, 85296, United States

Location

FDRC

Costa Mesa, California, 92627, United States

Location

Velocity Clinical Research San Diego

La Mesa, California, 91942, United States

Location

Velocity Clin Res Los Angeles

Los Angeles, California, 90017, United States

Location

LCGK Research

San Carlos, California, 94070, United States

Location

San Diego Family Care_San Diego

San Diego, California, 92111, United States

Location

Encompass Clinical Research_Spring Valley

Spring Valley, California, 91978, United States

Location

Med Partners, Inc.

Toluca Lake, California, 91602, United States

Location

University Clin Investigators

Tustin, California, 92780, United States

Location

Diablo Clinical Research, Inc.

Walnut Creek, California, 94598, United States

Location

Innovative Research of W Florida Inc.

Clearwater, Florida, 33756, United States

Location

Innovative Research of W FL

Clearwater, Florida, 33756, United States

Location

Alliance for Multispec Res

Coral Gables, Florida, 33134, United States

Location

Encore Medical Research LLC

Hollywood, Florida, 33024, United States

Location

New Horizon Research Center

Miami, Florida, 33165, United States

Location

Reyes Clinical Research, Inc

Miami, Florida, 33175, United States

Location

International Research Associates, LLC_Miami

Miami, Florida, 33183, United States

Location

South Broward Research LLC

Miramar, Florida, 33027, United States

Location

Adult Medicine of Lake County, Inc.

Mt. Dora, Florida, 32757, United States

Location

Omega Research Consultants LLC

Orlando, Florida, 32806, United States

Location

South Broward Research LLC

Pembroke Pines, Florida, 33027, United States

Location

Progressive Medical Research

Port Orange, Florida, 32127, United States

Location

CVS Store Number: 7689

Atlanta, Georgia, 30329-4015, United States

Location

CVS Store Number: 05520

Savannah, Georgia, 31405-6901, United States

Location

Elite Clinical Trials

Blackfoot, Idaho, 83221, United States

Location

Solaris Clinical Research

Meridian, Idaho, 83646, United States

Location

Macoupin Research Group

Gillespie, Illinois, 62033, United States

Location

Clin Invest Spec, Inc

Wauconda, Illinois, 60084, United States

Location

The Research Group of Lexington LLC

Lexington, Kentucky, 40503, United States

Location

MD Medical Research

Oxon Hill, Maryland, 20745, United States

Location

BTC of New Bedford, LLC

New Bedford, Massachusetts, 02740, United States

Location

Elite Research Center

Flint, Michigan, 48532, United States

Location

Arcturus Healthcare, PLC.

Troy, Michigan, 48098, United States

Location

Montana Medical Research

Missoula, Montana, 59808, United States

Location

N.Y. Family Practice Physicians

Woodhaven, New York, 11421, United States

Location

PharmQuest Life Sciences LLC

Greensboro, North Carolina, 27408, United States

Location

Whiteville Medical Assoc, PA

Whiteville, North Carolina, 28472, United States

Location

Albert J Weisbrot

Mason, Ohio, 45040-6815, United States

Location

Advanced Med Res Maumee

Maumee, Ohio, 43537, United States

Location

Tristar Clin Investigations, PC

Philadelphia, Pennsylvania, 19114, United States

Location

Spartanburg Medical Research

Spartanburg, South Carolina, 29303, United States

Location

Elligo Clin Res Centre

Austin, Texas, 78704, United States

Location

Velocity Clinical Res-Dallas

Dallas, Texas, 75230, United States

Location

UT Southwestern Med Cntr

Dallas, Texas, 75390-9302, United States

Location

Southwest Clinical Trials

Houston, Texas, 77081, United States

Location

Tapia Internal Medicine Clinic

Paris, Texas, 75462, United States

Location

Univ Of Texas Hlth Science Cntr

San Antonio, Texas, 78229, United States

Location

VIP Trials_San Antonio

San Antonio, Texas, 78230, United States

Location

VIP Trials

San Antonio, Texas, 78230, United States

Location

Dwayne O. Williams, M.D., P.A.

Sugar Land, Texas, 77479, United States

Location

Sugar Lakes Family Practice PA

Sugar Land, Texas, 77479, United States

Location

Martin Diagnostic Clinic

Tomball, Texas, 77375, United States

Location

CVS Store Number: 01396

Reston, Virginia, 20191-4327, United States

Location

CVS Store Number: 1537

Richmond, Virginia, 23230-3005, United States

Location

Wenatchee Valley Hospital and Clinics

Wenatchee, Washington, 98801-2028, United States

Location

Care Clinic

Red Deer, Alberta, T4P 1K4, Canada

Location

Ocean West Research Clinic

Surrey, British Columbia, V3Z 2N6, Canada

Location

G.A. Research Associates Ltd.

Moncton, New Brunswick, E1G 1A7, Canada

Location

Nova Scotia Hlth Halifax

Halifax, Nova Scotia, B3H 2Y9, Canada

Location

Centricity Research New Minas

New Minas, Nova Scotia, B4N 3R7, Canada

Location

Centricity Research Brampton

Brampton, Ontario, L6S 0C6, Canada

Location

LMC Clin Res Inc. Thornhill

Concord, Ontario, L4K 4M2, Canada

Location

Medical Trust Clinics, Inc.

Courtice, Ontario, L1E2J5, Canada

Location

Centricity Research Etobicoke

Etobicoke, Ontario, M9R 4E1, Canada

Location

Wharton Med Clin Trials

Hamilton, Ontario, L8L 5G8, Canada

Location

Milestone Research

London, Ontario, N5W 6A2, Canada

Location

Bluewater Clin Res Group,Inc

Sarnia, Ontario, N7T 4X3, Canada

Location

Canadian Centre for Research on Diabetes_Smiths Falls

Smiths Falls, Ontario, K7A 4W8, Canada

Location

LMC Endo Centres Ltd.(Bayview)

Toronto, Ontario, M4G 3E8, Canada

Location

LMC Manna Research

Toronto, Ontario, M4G 3E8, Canada

Location

Manna Research Quebec

Lévis, Quebec, G6W 0M5, Canada

Location

Recherche GCP Research

Montreal, Quebec, H1Y 3H5, Canada

Location

LMC Clin Rsrch Inc. (Montreal)

Montreal, Quebec, H4T 1Z9, Canada

Location

Centricity Res Pointe-Claire

Pointe-Claire, Quebec, H9R 4S3, Canada

Location

Manna Research Inc.

Pointe-Claire, Quebec, H9R 4S3, Canada

Location

Centricity Research Ville St. Laurent VSL

Saint-Laurent, Quebec, H4T 1Z9, Canada

Location

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

Legnica, Lower Silesian Voivodeship, 59-220, Poland

Location

ETG Lublin

Lublin, Lublin Voivodeship, 20-412, Poland

Location

Osteo Medic s.c. Artur Racewicz Jerzy Supronik

Bialystok, 15-351, Poland

Location

NZOZ Specjalistyczny Osrodek Internistyczno-Diabetologiczny Małgorzata Arciszewska

Bialystok, 15-435, Poland

Location

M2M Badania Kliniczne

Chorzów, 41-500, Poland

Location

NZOZ Gdanska Poradnia Cukrzycowa Sp.z o.o.

Gdansk, 80-858, Poland

Location

Krakowskie Centrum Medyczne Sp. z o.o.

Krakow, 31-501, Poland

Location

FutureMeds Sp. z o.o. Lodz

Lodz, 91-363, Poland

Location

ETG Lublin

Lublin, 20-412, Poland

Location

Centrum Medyczne "Diabetika"

Radom, 26-600, Poland

Location

PANSTWOWY INSTYTUT MEDYCZNY MSWiA

Warsaw, 02-507, Poland

Location

FutureMeds Sp. z o.o.

Wroclaw, 50-088, Poland

Location

Diabetologicka ambulancia DIASTYLE s.r.o.

Banská Bystrica, 97401, Slovakia

Location

Diabetologicka ambulancia DIAMO s.r.o.

Kežmarok, 06001, Slovakia

Location

IVAMEDIC s.r.o.

Košice, 040 11, Slovakia

Location

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

Martin, 036 01, Slovakia

Location

Diabetologicka ambulancia MUDr. Iveta Markova s.r.o

Nitra, 94911, Slovakia

Location

MUDr. Jan Culak, s.r.o.

Prievidza, 97101, Slovakia

Location

MEDI-DIA s.r.o.

Sabinov, 08301, Slovakia

Location

Medi-Clinic Bloemfontein

Bloemfontein, Free State, 9301, South Africa

Location

Moriana Clinical Research

Winnie Mandela, Free State, 9400, South Africa

Location

Shop#1 Health Emporium

Midrand, Gauteng, 1685, South Africa

Location

Prinshof Medical Campus

Pretoria, Gauteng, 0002, South Africa

Location

Jongaie Research

Pretoria, Gauteng, 0183, South Africa

Location

Clinical Trial Systems (CTC)

Pretoria, Gauteng, 0186, South Africa

Location

Dr A Amod

Durban, KwaZulu-Natal, 4092, South Africa

Location

Precise Clinical Solutions (Pty) Ltd

Durban, KwaZulu-Natal, 4092, South Africa

Location

Dr Pillay's Rooms

Durban, KwaZulu-Natal, 4450, South Africa

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Results Point of Contact

• Title: Clinical Reporting Anchor and Disclosure (1452)
• Organization: Novo Nordisk A/S

clinicaltrials@novonordisk.com

(+1) 866-867-7178

Study Officials

• Clinical Transparency (dept. 2834)

  Novo Nordisk A/S

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 26, 2022
• First Posted: July 28, 2022
• Study Start: August 3, 2022
• Primary Completion: August 9, 2023
• Study Completion: September 18, 2023
• Last Updated: December 12, 2025
• Results First Posted: October 9, 2024

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will share

Locations

SL (7); PL (12); CA (21); ZA (9); US (55)