Clinical trial NCT05478252: A Research Study to Compare Two Semaglutide Medicines in People With Type 2 Diabetes
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Diabetes Mellitus, Type 2
Lead sponsor: Novo Nordisk A/S
Sponsor class: INDUSTRY
First posted: 2022-07-28
Enrollment: 388
Sex: ALL
Minimum age (years): 18
Maximum age (years): 64
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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).


Eligibility criteria: 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.

Primary outcomes:
measure: Change in Glycosylated Haemoglobin (HbA1c)
timeFrame: From baseline (week 0) to end of treatment (week 28)
Secondary outcomes:
measure: Change in Body Weight
timeFrame: From baseline (week 0) to end of treatment (week 28)
measure: Number of Treatment-Emergent Adverse Events (TEAEs)
timeFrame: From the time of first dosing (week 0) to end of study (week 33)
measure: Occurrence of Anti-semaglutide Antibodies (Yes/no)
timeFrame: From baseline (week 0) to end of study (week 33)
measure: Occurrence of Anti-semaglutide Antibodies With In-vitro Neutralising Effect (Yes/no)
timeFrame: From baseline (week 0) to end of study (week 33)
measure: Occurrence of Anti-semaglutide Binding Antibodies Cross-reacting With Endogenous Glucagon Like Peptide-1 (GLP-1) (Yes/no)
timeFrame: From baseline (week 0) to end of study (week 33)
measure: Occurrence of In-vitro Neutralising Cross-reacting Antibodies to Endogenous GLP-1 (Yes/no)
timeFrame: At week 33
measure: Anti-semaglutide Antibodies Level Measured as Percentage (%) Bound/Total
timeFrame: At week 33
measure: Anti-semaglutide Antibodies Level (Measured as Titre)
timeFrame: At week 33
Other outcomes:
Locations:
city: La Mesa
country: United States
facility: Velocity Clinical Research San Diego
state: California
city: Los Angeles
country: United States
facility: Velocity Clin Res Wstlke
state: California
city: San Carlos
country: United States
facility: LCGK Research
state: California
city: San Diego
country: United States
facility: San Diego Family Care_San Diego
state: California
city: Toluca Lake
country: United States
facility: Med Partners, Inc.
state: California
city: Tustin
country: United States
facility: University Clin Investigators
state: California
city: Clearwater
country: United States
facility: Innovative Research of W Florida Inc.
state: Florida
city: Clearwater
country: United States
facility: Innovative Research of W FL
state: Florida
city: Hollywood
country: United States
facility: Encore Medical Research LLC
state: Florida
city: Miami
country: United States
facility: New Horizon Research Center
state: Florida
city: Miami
country: United States
facility: International Research Associates, LLC_Miami
state: Florida
city: Miramar
country: United States
facility: South Broward Research LLC
state: Florida
city: Pembroke Pines
country: United States
facility: South Broward Research LLC
state: Florida
city: Blackfoot
country: United States
facility: Elite Clinical Trials
state: Idaho
city: Lexington
country: United States
facility: The Research Group of Lexington LLC
state: Kentucky
city: New Bedford
country: United States
facility: BTC of New Bedford, LLC
state: Massachusetts
city: Flint
country: United States
facility: Elite Research Center
state: Michigan
city: Troy
country: United States
facility: Arcturus Healthcare, PLC.
state: Michigan
city: Woodhaven
country: United States
facility: N.Y. Family Practice Physicians
state: New York
city: Greensboro
country: United States
facility: PharmQuest Life Sciences LLC
state: North Carolina
city: Whiteville
country: United States
facility: Whiteville Medical Assoc, PA
state: North Carolina
city: Maumee
country: United States
facility: Advanced Med Res Maumee
state: Ohio
city: Philadelphia
country: United States
facility: Tristar Clin Investigations, PC
state: Pennsylvania
city: Spartanburg
country: United States
facility: Spartanburg Medical Research
state: South Carolina
city: Austin
country: United States
facility: Elligo Clin Res Centre
state: Texas
city: Dallas
country: United States
facility: Velocity Clinical Res-Dallas
state: Texas
city: Paris
country: United States
facility: Tapia Internal Medicine Clinic
state: Texas
city: Sugar Land
country: United States
facility: Sugar Lakes Family Practice PA
state: Texas
city: Tomball
country: United States
facility: Martin Diagnostic Clinic
state: Texas
city: Surrey
country: Canada
facility: Ocean West Research Clinic
state: British Columbia
city: Moncton
country: Canada
facility: G.A. Research Associates Ltd.
state: New Brunswick
city: Halifax
country: Canada
facility: Nova Scotia Hlth Halifax
state: Nova Scotia
city: Brampton
country: Canada
facility: Centricity Research Brampton
state: Ontario
city: Etobicoke
country: Canada
facility: Centricity Research Etobicoke
state: Ontario
city: Hamilton
country: Canada
facility: Wharton Med Clin Trials
state: Ontario
city: London
country: Canada
facility: Milestone Research
state: Ontario
city: Montreal
country: Canada
facility: Recherche GCP Research
state: Quebec
city: Montreal
country: Canada
facility: LMC Clin Rsrch Inc. (Montreal)
state: Quebec
city: Pointe Claire
country: Canada
facility: Manna Research Inc.
state: Quebec
city: Legnica
country: Poland
facility: Beata Mikłaszewicz&Dariusz Dąbrowski "CARDIAMED" s.j.
state: Dolnoslaskie
city: Lublin
country: Poland
facility: ETG Lublin
state: Lubelskie
city: Bialystok
country: Poland
facility: Osteo Medic s.c. Artur Racewicz Jerzy Supronik
city: Chorzów
country: Poland
facility: M2M Badania Kliniczne
city: Gdansk
country: Poland
facility: NZOZ Gdanska Poradnia Cukrzycowa Sp.z o.o.
city: Krakow
country: Poland
facility: Krakowskie Centrum Medyczne Sp. z o.o.
city: Lodz
country: Poland
facility: FutureMeds Sp. z o.o. Lodz
city: Lublin
country: Poland
facility: ETG Lublin
city: Radom
country: Poland
facility: Centrum Medyczne "Diabetika"
city: Warszawa
country: Poland
facility: PANSTWOWY INSTYTUT MEDYCZNY MSWiA
city: Banska Bystrica
country: Slovakia
facility: Diabetologicka ambulancia DIASTYLE s.r.o.
city: Kezmarok
country: Slovakia
facility: Diabetologicka ambulancia DIAMO s.r.o.
city: Kosice
country: Slovakia
facility: IVAMEDIC s.r.o.
city: Martin
country: Slovakia
facility: DIA - SANTMART, s.r.o., Ambulancia diabetologie a poruch latkovej premeny a vyzivy
city: Nitra
country: Slovakia
facility: Diabetologicka ambulancia MUDr. Iveta Markova s.r.o
city: Prievidza
country: Slovakia
facility: MUDr. Jan Culak, s.r.o.
city: Sabinov
country: Slovakia
facility: MEDI-DIA s.r.o.
city: Bloemfontein
country: South Africa
facility: Medi-Clinic Bloemfontein
state: Free State
city: Brandfort
country: South Africa
facility: Moriana Clinical Research
state: Free State
city: Midrand
country: South Africa
facility: Shop#1 Health Emporium
state: Gauteng
city: Pretoria
country: South Africa
facility: Prinshof Medical Campus
state: Gauteng
city: Pretoria
country: South Africa
facility: Jongaie Research
state: Gauteng
city: Pretoria
country: South Africa
facility: Clinical Trial Systems (CTC)
state: Gauteng
city: Durban
country: South Africa
facility: Dr A Amod
state: KwaZulu-Natal
city: Durban
country: South Africa
facility: Precise Clinical Solutions (Pty) Ltd
state: KwaZulu-Natal
city: Durban
country: South Africa
facility: Dr Pillay's Rooms
state: KwaZulu-Natal
Study officials:
affiliation: Novo Nordisk A/S
name: Clinical Transparency (dept. 2834)
role: STUDY_DIRECTOR
References: