A Research Study to Compare Two Semaglutide Medicines in People With Type 2 Diabetes
NCT ID: NCT05478252
Last Updated: 2025-12-12
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
388 participants
INTERVENTIONAL
2022-08-03
2023-09-18
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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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.
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).
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.
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).
Interventions
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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).
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).
Eligibility Criteria
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Inclusion Criteria
* 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).
* 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.
Exclusion Criteria
18 Years
64 Years
ALL
No
Sponsors
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Novo Nordisk A/S
INDUSTRY
Responsible Party
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Principal Investigators
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Clinical Transparency (dept. 2834)
Role: STUDY_DIRECTOR
Novo Nordisk A/S
Locations
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BTC of New Bedford, LLC
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N.Y. Family Practice Physicians
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Care Clinic
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Moncton, New Brunswick, Canada
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Beata Miklaszewicz&Dariusz Dabrowski "CARDIAMED" s.j.
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ETG Lublin
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Osteo Medic s.c. Artur Racewicz Jerzy Supronik
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NZOZ Specjalistyczny Osrodek Internistyczno-Diabetologiczny Małgorzata Arciszewska
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M2M Badania Kliniczne
Chorzów, , Poland
NZOZ Gdanska Poradnia Cukrzycowa Sp.z o.o.
Gdansk, , Poland
Krakowskie Centrum Medyczne Sp. z o.o.
Krakow, , Poland
FutureMeds Sp. z o.o. Lodz
Lodz, , Poland
ETG Lublin
Lublin, , Poland
Centrum Medyczne "Diabetika"
Radom, , Poland
PANSTWOWY INSTYTUT MEDYCZNY MSWiA
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FutureMeds Sp. z o.o.
Wroclaw, , Poland
Diabetologicka ambulancia DIASTYLE s.r.o.
Banská Bystrica, , Slovakia
Diabetologicka ambulancia DIAMO s.r.o.
Kežmarok, , Slovakia
IVAMEDIC s.r.o.
Košice, , Slovakia
DIA - SANTMART, s.r.o., Ambulancia diabetologie a poruch latkovej premeny a vyzivy
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Diabetologicka ambulancia MUDr. Iveta Markova s.r.o
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MUDr. Jan Culak, s.r.o.
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Medi-Clinic Bloemfontein
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Shop#1 Health Emporium
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Dr A Amod
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Countries
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Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
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U1111-1266-2391
Identifier Type: OTHER
Identifier Source: secondary_id
2021-001501-69
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
NN9535-4820
Identifier Type: -
Identifier Source: org_study_id
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