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): 401
• Phase: Phase 3

Contacts and Locations

• Study Contact: Name: Novo Nordisk; Phone Number: (+1) 866-867-7178; Email: clinicaltrials@novonordisk.com

Study Locations

• Canada
  • 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
  • Ontario
    • Brampton, Ontario, Canada, L6S 0C6
      • Centricity Research Brampton
    • Etobicoke, Ontario, Canada, M9R 4E1
      • Centricity Research Etobicoke
    • Hamilton, Ontario, Canada, L8L 5G8
      • Wharton Med Clin Trials
    • London, Ontario, Canada, N5W 6A2
      • Milestone Research
  • Quebec
    • Montreal, Quebec, Canada, H1M 1B1
      • Recherche GCP Research
    • Montreal, Quebec, Canada, H4T 1Z9
      • LMC Clin Rsrch Inc. (Montreal)
    • Pointe Claire, Quebec, Canada, H9R 4S3
      • Manna Research Inc.
• Poland
  • Bialystok, Poland, 15-351
    • Osteo Medic s.c. Artur Racewicz Jerzy Supronik
  • 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"
  • Warszawa, Poland, 02-507
    • Panstwowy Instytut Medyczny MSWiA
  • Dolnoslaskie
    • Legnica, Dolnoslaskie, Poland, 59-220
      • Beata Mikłaszewicz&Dariusz Dąbrowski "CARDIAMED" s.j.
  • Lubelskie
    • Lublin, Lubelskie, Poland, 20-412
      • Etg Lublin
• Slovakia
  • Banska Bystrica, Slovakia, 97401
    • Diabetologicka ambulancia DIASTYLE s.r.o.
  • Kezmarok, Slovakia, 06001
    • Diabetologicka ambulancia DIAMO s.r.o.
  • Kosice, 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
    • Brandfort, 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
  • California
    • La Mesa, California, United States, 91942
      • Velocity Clinical Research San Diego
    • Los Angeles, California, United States, 90057
      • Velocity Clin Res Wstlke
    • San Carlos, California, United States, 94070
      • LCGK Research
    • San Diego, California, United States, 92111
      • San Diego Family Care_San Diego
    • Toluca Lake, California, United States, 91602
      • Med Partners, Inc.
    • Tustin, California, United States, 92780
      • University Clin Investigators
  • Florida
    • Clearwater, Florida, United States, 33756
      • Innovative Research of W Florida Inc.
    • Hollywood, Florida, United States, 33021
      • Encore Medical Research LLC
    • Miami, Florida, United States, 33165
      • New Horizon Research Center
    • Miami, Florida, United States, 33183
      • International Research Associates, LLC_Miami
    • Miramar, Florida, United States, 33027
      • South Broward Research LLC
    • Pembroke Pines, Florida, United States, 33027
      • South Broward Research LLC
  • Idaho
    • Blackfoot, Idaho, United States, 83221
      • Elite Clinical Trials
  • Kentucky
    • Lexington, Kentucky, United States, 40503
      • The Research Group of Lexington LLC
  • 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.
  • 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
    • 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
    • Paris, Texas, United States, 75462
      • Tapia Internal Medicine Clinic
    • Sugar Land, Texas, United States, 77479
      • Sugar Lakes Family Practice PA
    • Tomball, Texas, United States, 77375
      • Martin Diagnostic Clinic

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 Glycated Haemoglobin (HbA1c)	Measured as Percentage	From baseline visit (visit 2; week 0) to end of treatment visit (visit 10; week 28)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Body Weight	Measured in Kilogram	From baseline visit (visit 2; week 0) to end of treatment visit (visit 10; week 28)
Number of Treatment-Emergent Adverse Events	Measured as Number of events	From the time of first dosing (visit 2; week 0) to end of study visit (visit 11; week 33)
Occurence of Anti-semaglutide Antibodies (Yes/no)	Measured as Number of participants	From baseline visit (visit 2; week 0) to end of study visit (visit 11; week 33)
Occurence of Anti-semaglutide Antibodies With In-vitro Neutralising Effect (Yes/no)	Measured as Number of participants	From baseline visit (visit 2; week 0) to end of study visit (visit 11; week 33)
Occurence of Anti-semaglutide Binding Antibodies Cross-reacting With Endogenous Glucagon Like Peptide-1 (GLP-1) (Yes/no)	Measured as Number of participants	From baseline visit (visit 2; week 0) to end of study visit (visit 11; week 33)
Occurence of In-vitro Neutralising Cross-reacting Antibodies to Endogenous GLP-1 (Yes/no)	Measured as Number of participants	From baseline visit (visit 2; week 0) to end of study visit (visit 11; week 33)
Anti-semaglutide Antibodies Level Measured as %Bound/Total	Antibody levels will be measured in percentage of bound radioactivity-labelled semaglutide/total added radioactivity-labelled semaglutide (%B/T; B =Bound, T = Total).	From baseline visit (visit 2; week 0) to end of study visit (visit 11; week 33)
Anti-semaglutide Antibodies Level (Measured as Titre)	Measured as Titre	From baseline visit (visit 2; week 0) to end of study visit (visit 11; 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 (Estimated): February 23, 2024
• Last Update Submitted That Met QC Criteria: February 21, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Diabetes Mellitus; Diabetes Mellitus, Type 2
• 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